Zhanine tablets use. "Janine": effectiveness and side effects of hormonal contraceptives

Latin name: JEANINE
ATX code: G03A A16
Active substance: ethinyl estradiol, dienogest
Manufacturer: BAYER PHARMA (Germany)
Release from the pharmacy: On prescription
Storage conditions: in the dark, at temperatures up to 25 °C
Best before date: 3 years

The drug Janine is one of the most effective means of modern oral contraception.

Composition and dosage form

One dragee Janine contains the following components:

• Active: 30 mcg ethinyl estradiol, 2 mg dienogest
• Additional: lactose (in the form of monohydrate), potato starch, gelatin, E572, talc, sucrose, glucose syrup, macrogol-35000, calcium carbonate, povidone K-25, E171, palm wax.

Contraceptive drugs are available in the form of pills - small pills with a white coating. The product is packaged in blisters of 21 pieces. In a cardboard pack there are 1 or 3 plates, an accompanying annotation.

Medicinal properties

The contraceptive effect of Janine occurs due to the targeted action of two components - ethinyl estradiol and dienoget. The processes they trigger cause multiple biochemical reactions, the most significant among them are blocking ovulation, changing the structure and composition of cervical secretion. As a result of the influence of OC, sperm lose the ability to penetrate the uterine cavity.

When all conditions of administration are met, the value of the Pearl index is less than 1. If the pills are taken with omissions or there are other violations, then the value increases.

Due to the gestagenic properties of dienogest, OC has an antiandrogenic effect, which is confirmed by numerous studies and observations. In addition to the contraceptive effect, the substance simultaneously has a beneficial effect on blood characteristics, increasing the content of dense lipoproteins.

Patients who took Zhanine noted that as a result of OK, the circulatory cycle was normalized, the intensity of PMS decreased or disappeared completely, the duration or intensity of menstruation was reduced, which sharply reduced the threat of IDA. In addition, there is medical evidence that the contraceptive can prevent the occurrence of ovarian and/or endometrial cancer.

• Dienogest

Belongs to the group of nortestosterone derivatives, has pronounced antiandrogenic properties, and is characterized by a strong progestogenic effect. After penetration into the uterine cavity, it affects the nerve endings of the endometrium, suppressing trophic effects. With long-term use, it helps to attenuate endometrioid lesions and reduces the increased synthesis of estrogen by the ovaries.

After taking the pill, the substance is absorbed quite quickly from the gastrointestinal tract, peak concentration values ​​are formed after 2.5-3 hours. It is characterized by high bioavailability - almost 96%. Almost completely metabolized.

It is excreted from the body mainly through urine, a small amount is excreted along with bile. The duration of the process ranges from 8 to 10 hours.

• Ethinyl estradiol

The substance is a synthetic analogue of the hormone estrogen, and therefore has almost the same effect. Activates the formation of the uterus, tubes and secondary signs of sex, affects the condition of the endometrium, increases the excitability of the uterus. In addition, the artificial compound is involved in nitrogen metabolism, reduces lipid content, and regulates the presence of cholesterol. In large doses, it can retain fluid in the body, contributing to swelling.

After oral administration, it is quickly and completely absorbed. The highest concentrations are formed within 1-4 hours. Transformed to form metabolites in the small intestine and liver. It is excreted from the body in two stages along with urine and bile.

Mode of application

The instructions for use for taking Zhanine prescribe one tablet per day, at the same hours and in accordance with the calendar index on the blister. It is not advisable to bite or break the dragee - you should only drink it whole with a small amount of water. After the contents of the blister are finished, a one-week break is observed, during which menstrual-like bleeding should occur. It usually occurs 2-3 days after taking the last pill. After a week, they resume taking OK from a new blister.

When to start drinking OK

If before Zhanine’s appointment the patient was not protected by other OCs or there was a break in taking it for at least a month, then the first pill should be taken on the 1st day of the MC. If this is done later - between days 2 and 5, then you will need an additional week of protection with condoms.

If other OCs are used before Janine, the pills are drunk the next day after taking the previous active tablet (or placebo). In this case, a break of more than a week should not be allowed.

If a woman was protected using a TD patch or vaginal ring, then the pills are drunk on the day the product is removed. In the case of injections - on the day of the next injection.

After stopping the course of drugs with gestagens, start taking pills the next day after taking the tablet from the previous OC, on the day of removal of the uterine contraceptive or on the day of the next hormonal injection. In all cases, additional protection with barrier agents will be required.

After a miscarriage or abortion in the first 3 months of pregnancy, Janine is taken immediately after the termination of pregnancy.

If the pregnancy ends in the 2nd stage, then you need to wait from 21 to 28 days before taking Janine. Later intake should be accompanied by the use of condoms. If an unprotected PA occurred before taking the pill, you will need to make sure there is no pregnancy or postpone the course until your period begins.

What to do in case of omissions OK

If for some reason a woman was unable to drink the pills on time, and the delay was less than 12 hours, then there is nothing particularly to worry about, since the content of substances in the blood, although it will decrease somewhat, will retain the contraceptive effect. She'll just have to take the pills as soon as the opportunity arises.

If more than 12 hours are missed, the contraceptive concentration of the medication will decrease more, and to restore the normal dosage schedule, the woman can use one of the following methods:

• Missing the first week of the course: take the forgotten pill, and the next one according to the schedule. If the methods coincide, drink two pieces at once and then use additional means of protection for a week.
• Skipping in the 2nd week of the course: drink the missed one, and the next one according to the schedule, if the doses coincide - two pieces at once. If there were no violations in the course in the first 7 days, then there is no need for condoms. In case of the same forgetfulness, use them for a week.
• Skipping in the 3rd week of the course: take the forgotten pill and another at the usual hours. After finishing one blister, start a new one, without observing any intervals. Withdrawal bleeding should not occur, but may appear as spotting or breakthrough bleeding.

There is another option to correct the situation: do not replenish the tablets, but take a 7-day break, and after it ends, start a new package of OK.

A decrease in the concentration of substances may occur due to vomiting or diarrhea in the first 4 hours after administration. In this case, you will need to drink another pill.

• How to delay or reschedule a MC day

To reschedule your period to another day, you do not need to take a break, but immediately start taking a new blister and drink the number of pills that you need until it ends completely. Then wait 7 days without pills before taking from the next pack.

To change the start of the MC to a different date, you need to shorten the break by the desired number of days.

Reception features

Teenagers can take Janine only after the first bleeding occurs.

Older women in menopause do not require OC.

If the patient has liver problems, then OK can be taken only after the condition has completely stabilized.

The nuances of taking it in women suffering from kidney pathologies have not been studied. Therefore, it is better to check with your gynecologist whether you can drink OK or not and how to take Janine correctly.

Janine's therapy for endometriosis

Thanks to the active substances it contains, the contraceptive medication can be used in the treatment of endometrial pathology. A significant advantage of OK is that it can be taken in various forms of the disease: both in the early stages and in advanced cases. Depending on the indications, the most effective option is developed for each patient. On average, treatment with the drug takes about 63 days, that is, you need to drink 3 blisters of 21 tablets.

Application regimen: one tablet per day, strictly at one hour. After completing the dose, a seven-day break is observed for menstrual bleeding.

After analyzing the results of therapy, the gynecologist makes a decision whether it is necessary to continue taking the OC. But usually one course of Janine’s therapy for endometriosis is enough to eliminate excess tissue growth.

If the pathology is more advanced, then the course of therapy may take a longer time - 84 days.

During pregnancy and lactation

Average price: No. 21 – 1005 rubles, No. 63 – 2480 rubles.

The drug should not be used while pregnant or breastfeeding. If during the course it turns out that a woman is pregnant, you must immediately stop taking the medication to avoid unforeseen consequences. but so far, various epidemiological studies have not confirmed any pathologies in the development of children born to women who took hormonal pills Janine in the early stages of pregnancy.

Lactating women should not use the medication, as the active ingredients can negatively affect the production and volume of milk. In addition, small amounts of sex hormones and their metabolites may be excreted into milk. If a woman needs to take OK, she must stop lactation during the course of the pills.

Contraindications

Contraceptive pills Janine should not be taken if at least one of the following factors is present. If during the course such conditions or pathologies arose for the first time, then hormonal OC should be immediately discontinued. The drug is prohibited for:

• Thrombosis or thromboembolism at the time of prescription or in the past
• Diseases or conditions that increase the risk of blood clots (current or past)
• Congenital or acquired tendency to thrombosis
• Existing high risk of venous/arterial thrombosis
• Migraines with associated neurological manifestations at the time of prescription or in the past
• Diabetes with damage to the vascular system
• Pancreatitis with severely elevated plasma triglyceride concentrations (current and past)
• Renal failure, severe organ damage (use is possible only after
• Liver neoplasms (benign and malignant) at the time of Zhanine’s appointment or existing in the past
• Benign hormone-dependent neoplasms confirmed by examination and the assumption of their presence
• Vaginal bleeding of unspecified origin
• Confirmed or suspected pregnancy, breastfeeding
• Individual hypersensitivity to the components of Janine
• Congenital lactose intolerance, deficiency of lactase, sucrase in the body, GG malabsorption syndrome (due to lactose and sucrose present in the composition).

OCs should be used with caution if a woman has:

• Predisposition, risk of pulmonary embolism, thrombosis and conditions preceding them
• Tobacco smoking
• Overweight, obesity
• Hypertension amenable to drug correction
• Migraine without focal symptoms
• Congenital tendency to thrombus formation.
• Pathologies that can provoke the development of thrombosis due to circulatory disorders (SLE, diabetes, KS anemia, Crohn's disease, etc.)
• Liver diseases that are not included in the list of categorical contraindications
• Pathologies that first appeared during pregnancy or worsened during gestation
• Postnatal period (about one and a half months).

Precautionary measures

OK Janine should be prescribed by a gynecologist after a thorough analysis of the patient’s condition through a general and gynecological examination, passing tests and clarifying the intricacies of family history, unfavorable conditions in the past, the presence of bad habits and other risk factors. In case of indications for long-term use, the patient should be informed of the need for regular examinations by physicians (usually once a year). In addition, she should be warned that OC cannot protect against sexually transmitted infections and HIV infection.

If a woman has any risk signs that can accelerate or intensify the onset of new diseases or complications of existing ones, then the question of the possibility of using OCs should be decided individually. If prescribed, the patient must be aware of the possible consequences and know what to do if they occur.

The results of numerous studies have confirmed the presence of a relationship between taking OCs and an increase in cases of pathologies of the heart and blood vessels: MI, thrombosis, PE, VTE, etc. Although such complications occur quite rarely, the threat cannot be excluded.

The occurrence of VTE is especially common in the first year of taking OCs. An increase in risk is also noted when the course of OK is resumed after a break (at least a month). This usually happens in the first three months of taking contraceptives.

In addition, there is data on isolated cases where the use of OCs led to death.

Damage to blood vessels of other organs is observed less frequently, so medical opinions are divided on the issue of the “guilt” of OK. Manifestations of hepatic vein thrombosis include the development of unilateral swelling of the leg (pain in the vein area is possible), pain and discomfort in the limb when walking or standing, local temperature, and changes in skin tone.

PE can be recognized by the following signs:

• Difficulty breathing
• Unexplained cough (sometimes with blood)
• Severe chest pain, more intense when inhaling
• Vertigo
• Disturbance of normal heartbeat.

In addition, dyspnea and cough can be precursors of PE, so it is important to interpret them correctly and not confuse them with manifestations of other diseases.

Arterial TE can provoke stroke, MI, and vascular damage. Its manifestations are:

• Unexpected weakness
• Insensitivity of the face, limbs (specific symptom - unilateral paresthesia)
• Spontaneous blackout
• Speech Impairment
• Sudden deterioration of vision
• Gait disorder
• Disorientation in space
• Uncoordinated movements, loss of balance
• Spontaneous severe headache
• Fainting (may be with an epileptic attack).

Typical signs of MI are:

• Pain and discomfort in the chest, a feeling of heaviness or fullness
• Unpleasant sensations radiating to the back, arm, stomach
• Cold perspiration, sweat
• Nausea (with or without vomiting)
• Unexplained weakness, dyspnea
• Increased anxiety
• Rapid heartbeat.

The risk of thrombosis increases:

• As age increases
• In smokers (especially women 35+ with a long history)
• For obesity
• Presence of pathology in relatives
• Prolonged remaining stationary (including during long flights)
• For hypertension, heart valve pathology, atrial damage
• Postpartum period.

Women who have recently given birth, diabetics, patients with SLE, chronic intestinal inflammation, and KS anemia are also at risk.

The occurrence of migraines or worsening attacks is a reason to discontinue the OC.

Cross-drug interactions

Combining the use of OCs with other medications may cause breakthrough bleeding or reduce the effect of OCs, which will increase the risk of unplanned pregnancy. Therefore, Zhanin’s instructions for use advise taking birth control pills, taking into account possible complications. Such undesirable reactions occur in the following combinations:

• The use of drugs that induce liver enzymes can increase the clearance of sex hormones. Such reactions occur when Janine is combined with barbiturates, Phenytoin, and the anti-tuberculosis drug Rifampicin. It is assumed that Oxcarbazpin, Griseofulvin, and medications based on St. John's wort have the same effects.
• Similar effects can be observed when combined with HIV protease inhibitors (PIs) and NNRTIs: Ritonavir and Nevirapine, since the drugs directly affect the rate of hepatic metabolism.
• Certain antibiotic drugs (primarily tetracycline and penicillin groups) can reduce the content of ethinyl estradiol by reducing the circulation of estrogen in the liver and intestines. Therefore, if treatment with these agents is necessary, the patient is recommended to additionally protect herself using other barrier agents or products.
• The effect of OCs changes under the influence of drugs inhibitors of cytochrome CYP3A4 enzymes. The plasma content of Janine's substances will be increased when the contraceptive drug is combined with Ketoconazole and other antimycotics, Cimetidine, Erythromycin, psychotropic drugs (antidepressants), as well as with grapefruit juice.
• If during Janine’s course drugs were used that affect liver enzymes, then after their withdrawal you should use auxiliary means of protection against pregnancy for 28 days.
• Antibiotics reduce the contraceptive effect of OCs (except for Rifampicin, griseofulvin), therefore, during their course and for a week after discontinuation, you should either abstain from intimacy or take additional protection.
• Oral contraceptives can also change the actions of other drugs. Janine increases the plasma levels of Cyclosporine and reduces Laomtrigine.

If at the time of prescribing Janine the conditions for combining it with other medications were not specified, then if other drugs are prescribed, you must inform the doctor about the OC you are taking and clarify the nuances of joint use.

Side effects and overdose

When using Zhanine tablets, the following body reactions are possible:

• Infectious pathologies: vaginitis, thrush, salpino-oophoritis, oral herpes, influenza-like condition, bronchitis, diseases of the urinary tract, respiratory system
• Neoplasms of any etiology, uterine fibroids, lipoma (fat) of the mammary gland
• Blood-forming organs: anemia
• Individual reactions due to hypersensitivity
• Virilism
• Metabolic processes: increased or lack of appetite
• Psycho-emotional state: mental disorders, depression, sleep disturbances, insomnia, unmotivated aggression, mood lability, loss of sexual interest
• NS: headaches, vertigo, migraines, stroke, circulatory disorders in the brain, dystonia
• Visual organs: dryness of the mucous tissues of the eyes, irritation, decreased visual acuity, pain, inability to wear contact lenses
• Hearing organs: temporary hearing loss or decrease, tinnitus
• CVS: cardiovascular complications, rapid heartbeat, sharp increase or decrease in blood pressure, thrombus formation, thrombophlebitis, varicose veins, flushing of the face, dilated and painful veins
• Respiratory system: asthma attacks, hyperventilation
• Gastrointestinal tract: pain in the peritoneum, nausea, vomiting, diarrhea, gastritis, inflammation of the small intestine, difficulty digesting
• Skin: acne, rash, hair loss, baldness, itching, dermatitis (allergic and atopic), hyperpigmentation, chloasma, seborrhea, male pattern hair, cellulite, nevus, urticaria, erythema multiforme
• Locomotor system: pain in the back muscles, bones, limbs
• Reproductive system: breast discomfort and tenderness, intermenstrual bleeding, cyst (uterus, mammary glands), mastopathy, cervical dysfunction, nipple discharge
• Other disorders: fatigue, chest pain, peripheral edema, “flu-like” state, increased irritability, accumulation of fluid in the body, weight change (increase or decrease), increased TG levels in the blood.

Possible risks of using Janine

• Women who use hormonal pills are slightly more likely to be diagnosed with breast cancer than women who do not take contraceptives. There is no evidence yet of a direct relationship between the occurrence of pathology and the use of OCs.
• In patients with congenital angioedema, the risk of exacerbation increases.
• Increased threat of liver damage
• Impaired glucose tolerance and insulin resistance
• Breakthrough bleeding if other drugs were used while using OK Janine.

Consequences of taking overdoses

The active ingredients have virtually no acute toxicity, so the development of intoxication is unlikely. It is assumed that the medicine Janine, taken in overdoses, can cause increased side effects, but mainly the consequences manifest themselves in the form of nausea, vomiting, and girls may experience spotting.

Due to the lack of a specific antidote to Janine, the resulting unfavorable condition can be relieved with the help of symptomatic therapy.

Analogs

If for some reason a woman cannot take the medication, she should contact a gynecologist so that he can determine what to replace Janine with. Today, there are many drugs that act no less effectively: Bonade, Vidora, Jess and Jess Plus, Microgenon, Leya, etc. Which drug is best will be determined only by an experienced specialist.

Laboratorios Leon-Farma (Spain)

Average cost:(21 pcs.) – 395 rub., (63 pcs.) – 876 rub.

An oral contraceptive containing the same composition of active ingredients and in an identical dosage as in Janine. The slight difference lies only in the composition of the auxiliary ingredients included in the structure of the core and shell, and the dosage form: the medication is produced in tablets.

The dosage regimen is also similar: one piece per day.

Pros:

• Helps with serious disorders of the reproductive system
• Can be drunk for a long time.

Flaw:

• Side effects
• Decreased sensitivity in erogenous zones.

GEDEON RICHTER (Hungary)

Average cost: No. 21 – 723 rubles, No. 63 – 1813 rubles.

A contraceptive medication whose effect is provided by ethinyl estradiol and chloramadinone in the form of acetate.

OK is available in tablets. The drug is designed for 21 days of use with a mandatory one-week break for withdrawal bleeding.

Pros:

• Good quality
• Protects against unnecessary pregnancy.

Flaws:

• Acne appears
• Reduces interest in sex.

The drug Zhanine is a hormonal microdosed 1 monophasic 2 combined 3 oral 4 contraceptive 5

1 Microdosed– means that the estrogenic component in the drug is contained in a microdose. This allows you to minimize the risks of developing unwanted side effects and improve the tolerability of the drug.

2 Monophasic– means that one medicinal tablet contains a fixed (identical in each tablet) combination of active medicinal substances.

3 Combined– the drug contains two active substances (synthetic female sex hormones):

• Dienogest - hybrid progesterone - 2.0 mg
• Ethinyl estradiol - active estrogen in microdose - 0.03 mg

4 Oral– the drug is taken orally in a convenient form, “per os - through the mouth,” i.e. The tablet must be swallowed with water.

5 Contraceptive- this means that the target effect of the drug is to protect a woman from unwanted pregnancy.

So, Janine, first of all, a hormonal contraceptive. But a number of additional advantages allow it to be used for the treatment of certain gynecological and other diseases: simplex, acne, etc.

Endometriosis is a pathological benign process during which tissue similar to the endometrium begins to grow not in the uterine cavity, but where it should not be. For example: in the abdominal cavity, bladder, lungs, myometrium, ovaries, fallopian tubes, vagina...

More about endometriosis: its forms, symptoms, causes of development, diagnosis and treatment read

Endometriosis – estrogen dependent disease. Under the influence of cyclical fluctuations in the level of sex hormones, the same changes occur in the foci of endometriosis as in the mucous membrane of the uterus.

Wherever the endometrioid tissue is located, during menstruation it “menstruates”—it becomes inflamed and bleeds, just like the endometrium. During this period, the disease worsens: pelvic pain intensifies; menstruation becomes painful, prolonged, heavy; the functioning of organs affected by endometriosis is damaged. All this leads to poor health, loss of strength and ability to work for the suffering woman. Very often, endometriosis is accompanied by infertility.

Medicines from the COC group can relieve some pathological symptoms. Of all the COCs, Janine is recommended for the treatment of endometriosis.

How does Janine work for endometriosis?

Zhanin's therapeutic mechanism is associated with blockade of gonadotropic releasing factor (GnRH).

The principle of action of Janine for endometriosis:
The drug introduces the same, strictly defined amount of sex steroids into the body every day. Consequently, hormonal “bursts” disappear and ovulation does not occur. No ovulation - no menstruation. Symptoms of the disease subside and remission occurs. The patient feels healthy.

By “leveling out” the hormonal levels, Janine plunges the woman’s reproductive system into a state of “medicinal rest.” The artificial period of “ovarian rest” is similar to the natural period of pregnancy or lactation. At this time, structural restructuring, degradation and atrophy of endometriosis foci occurs.

Along with antiproliferative, Janine has anti-inflammatory (inhibits the synthesis of prostaglandins - mediators of the pro-inflammatory cascade) and antiandrogenic effects.

The combination of strong progesterone and scanty estrogenic effects ensures good tolerability of the drug.

The effectiveness of the drug Zhanine for endometriosis - reviews

Any hormonal therapy for endometriosis does not guarantee final recovery. The productivity of the mild therapeutic effects of COCs is quite low.

The effectiveness of treatment of minor forms of endometriosis by Janine is 58%

In what cases is treatment of endometriosis with this drug advisable?
Indications for use of Zhanine for endometriosis:

• Suspicion of uterine endometriosis, i.e. There are symptoms of the disease, but there is no indisputable objective laboratory and instrumental confirmation of the disease.
• Minor forms of endometriosis.
• Mild endometriosis.
• Endometriosis of the uterus (adenomyosis) stages 1-2.
• Treatment of endometriosis-related pelvic pain.
• Dysmenorrhea.
• Prevention of secondary anemia associated with hyperpolymenorrhea.
• Prevention of disease relapse after surgical treatment of external genital endometriosis.
• As a maintenance treatment after completing a course of GnRH A.
• Restoring fertility.

Treatment of endometriosis by Janine

“Extended regimen” means that the medicine is taken over a long course, for 3-6-9 months to 1.5 years.

The hormonal drug Janine is used only as directed and under supervision
specialist doctor with strict adherence to an individual dosage regimen

How much to drink Janine for endometriosis:

(doctor's consultation required)

Scheme: 42+7
In this case, Janine is taken for 42 days in a row, one tablet once a day.
Then there is a week break (No need to take pills for 7 days).
After which the drug is taken again for 42 days in a row until the next 7-day break, etc.

If you take the pills every day, you will not get your period. Menstruation (withdrawal bleeding) occurs during a 7-day break from taking the medicine (in this case - once every 2 months).

Menstruation during the course of treatment with Janine is, as a rule, quite scanty. This indicates the effectiveness of therapy.

How long to take Janine for endometriosis?
The duration of the course of treatment is six months, nine months, a year... - prescribed by the attending physician.

Janine - instructions for use for endometriosis

How to take Janine for endometriosis?

• 1 tablet 1 time per day at the same time, preferably in the evening after meals.
• Recommended dosage regimen for endometriosis: 63+7 (see above)

The first blister contains 21 tablets.

The release form of Janine is different:

• There are packages with 1 blister in 1 box.
• There are packages with 3 blisters in 1 box.

What to do if for some reason you did not take the pill on time?
If the evening dose of the drug is missed, then the “forgotten” tablet should be taken in the morning of the next day. The next tablet is taken in the evening of the same day at the usual time.

What to do if, against the background of continuous use of Janine, “menstruation” suddenly begins?
It happens that during the period of continuous use of pills, scanty spotting bloody discharge from the uterus or similar to menstruation appears “ breakthrough bleeding" At the same time, light menstruation occurs as expected - during the break between doses of the drug.

There is no need to be afraid of these phenomena. They do not pose any threat to health (let alone life) and do not mean that the treatment is ineffective. It is enough to address this problem to “your” gynecologist. If necessary, the doctor will adjust the individual dosage regimen.

In most cases, scanty intermenstrual bleeding does not require discontinuation of the drug and goes away on its own, after the body and uterine mucosa get used to the treatment.

Despite the high safety profile and good tolerability, the use of Janine (like any hormonal drug) has a number of limitations.

Absolute contraindications to taking Janine:

• Oncological diseases: any malignant or benign tumors, including carcinoma of the uterus and appendages.
• Pregnancy and breastfeeding.
• Thrombophlebitis, thrombosis, thromboembolism of veins, arteries of any location.
• Uncompensated or complicated by vascular pathology diabetes mellitus.
• Severe form of migraine.
• Uncompensated cardiovascular pathology.
• Uncompensated liver diseases.
• Intolerance (allergy) to any component of the drug.
• Psychopathology.

In other cases, Janine is prescribed by a gynecologist with the permission of the therapist after consultation with doctors of other specialties.

Patients with the following diseases (conditions) should take Zhanine with caution:

• Epilepsy.
• Obesity.
• Smoking.
• Diabetes.
• Pathology of the gastrointestinal tract.
• SLE, Crohn's disease.
• Phlebitis, arteritis.
• Hypertension.
• Tendency to angioedema.
• Atherosclerosis, lipid metabolism disorder.
• Sickle cell anemia.
• Multiple sclerosis.

If muscle spasms, swelling, severe pain in the limbs, severe headaches, intense chest pain, deterioration in visual acuity, or vomiting appear during treatment with Zhanine, you should stop taking the drug and immediately consult a doctor.

There are no direct contraindications to drinking alcohol. But ethyl alcohol is toxic. It worsens the tolerability of the drug, creates additional stress on the liver, and can provoke negative (sometimes fatal) conditions. In addition, drinking alcohol is one of the factors that increases the risk of developing endometriosis. Therefore, any woman should give up alcohol in principle.

Tradename

Dosage form

Compound

Each dragee contains:

Active ingredients: ethinyl estradiol 0.03 mg and dienogest 2.0 mg.

Excipients: lactose monohydrate, potato starch, gelatin, talc, magnesium stearate, sucrose, dextrose (glucose syrup), macrogol 35000, calcium carbonate, povidone K25, titanium dioxide (E 171), carnauba wax.

Description

White smooth dragees.

Pharmacotherapeutic group

Combined contraceptive (estrogen + gestagen)

ATX code G03AA

Pharmacological properties

Pharmacodynamics

Zhanine is a low-dose monophasic oral combined estrogen-progestogen contraceptive drug.

The contraceptive effect of Janine is carried out through complementary mechanisms, the most important of which include suppression of ovulation and a change in the viscosity of cervical mucus, as a result of which it becomes impermeable to sperm.

When used correctly, the Pearl index (an indicator reflecting the number of pregnancies in 100 women taking a contraceptive during the year) is less than 1. If pills are missed or used incorrectly, the Pearl index may increase.

The progestin component of Janine, dienogest, has antiandrogenic activity, which is confirmed by the results of a number of clinical studies. In addition, dienogest improves the blood lipid profile (increases the amount of high-density lipoproteins).

In women taking combined oral contraceptives, the menstrual cycle becomes more regular, painful menstruation is less frequent, the intensity and duration of bleeding decreases, resulting in a reduced risk of iron deficiency anemia. In addition, there is evidence of a reduced risk of endometrial and ovarian cancer.

Pharmacokinetics

· Dienogest

Absorption. When taken orally, dienogest is rapidly and completely absorbed, its maximum serum concentration of 51 ng/ml is achieved after approximately 2.5 hours. Bioavailability is approximately 96%.

Distribution. Dienogest binds to serum albumin and does not bind to sex steroid binding globulin (SGBS) and corticoid binding globulin (CBG). About 10% of the total concentration in the blood serum is found in free form; about 90% are not specifically associated with serum albumin. Induction of SHPS synthesis by ethinyl estradiol does not affect the binding of dienogest to serum protein.

Metabolism. Dienogest is almost completely metabolized. Serum clearance after a single dose is approximately 3.6 L/h.

Excretion. The half-life is about 8.5-10.8 hours. A small amount in unchanged form is excreted by the kidneys in the form of metabolites (half-life - 14.4 hours), which are excreted by the kidneys and through the gastrointestinal tract in a ratio of approximately 3:1.

Equilibrium concentration. The pharmacokinetics of dienogest is not affected by the level of SHPS in the blood serum. As a result of daily administration of the drug, the level of the substance in the serum increases approximately 1.5 times.

· Ethinyl estradiol

Absorption. After oral administration, ethinyl estradiol is rapidly and completely absorbed. The maximum serum concentration of approximately 67 pg/ml is achieved within 1.5-4 hours. During absorption and first passage through the liver, ethinyl estradiol is metabolized, resulting in its oral bioavailability averaging about 44%.

Distribution. Ethinyl estradiol is almost completely (approximately 98%), although nonspecifically, bound by albumin. Ethinyl estradiol induces the synthesis of SHBG. The apparent volume of distribution of ethinyl estradiol is 2.8 - 8.6 l/kg.

Indications for use

Contraception.

Contraindications

Janine should not be used if you have any of the conditions/diseases listed below. If any of these conditions develop for the first time while taking it, the drug should be discontinued immediately.

· Thrombosis (venous and arterial) and thromboembolism currently or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke), cerebrovascular disorders.
· Conditions preceding thrombosis (including transient ischemic attacks, angina) currently or in history.
· Migraine with focal neurological symptoms currently or in history.
· Diabetes mellitus with vascular complications.
· Multiple or severe risk factors for venous or arterial thrombosis, including complicated lesions of the heart valve apparatus, atrial fibrillation, cerebral vascular disease or coronary artery disease; uncontrolled arterial hypertension, major surgery with prolonged immobilization, smoking over the age of 35 years.
· Pancreatitis with severe hypertriglyceridemia, currently or in history.
· Liver failure and severe liver disease (until liver tests normalize).
· Liver tumors (benign or malignant) currently or in history.
· Identified or suspected hormone-dependent malignant diseases (including genital organs or mammary glands).
· Bleeding from the vagina of unknown origin.
· Pregnancy or suspicion of it.
· Breastfeeding period.
· Hypersensitivity to any of the components of the drug Janine.

With caution

The potential risks and expected benefits of using combined oral contraceptives should be carefully weighed in each individual case in the presence of the following diseases/conditions and risk factors:

· Risk factors for the development of thrombosis and thromboembolism: smoking; obesity; dyslipoproteinemia, arterial hypertension; migraine; heart valve defects; prolonged immobilization, serious surgical interventions, extensive trauma; hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the immediate relatives)
· Other diseases in which peripheral circulatory disorders may occur: diabetes mellitus; systemic lupus erythematosus; hemolytic uremic syndrome; Crohn's disease and ulcerative colitis; sickle cell anemia; phlebitis of superficial veins
Hereditary angioedema
Hypertriglyceridemia
Liver diseases
· Diseases that first appeared or worsened during pregnancy or against the background of previous use of sex hormones (for example, jaundice, cholestasis, gallbladder disease, otosclerosis with hearing impairment, porphyria, herpes of pregnancy, Sydenham's chorea)
· Postpartum period

Pregnancy and lactation
Janine should not be used during pregnancy and breastfeeding. If pregnancy is detected while taking the drug Janine, it should be discontinued immediately and consult a doctor. However, extensive epidemiological studies have not revealed an increased risk of developmental defects in children born to women who received sex hormones before pregnancy or when taking sex hormones inadvertently in early pregnancy.
Taking combined oral contraceptives may reduce the amount of breast milk and change its composition, so their use is not recommended until you stop breastfeeding.

Directions for use and doses

When and how to take pills
The calendar pack contains 21 tablets. In the package, each pill is marked with the day of the week on which it should be taken. Take the tablets orally at the same time every day with a small amount of water. Follow the direction of the arrow until all 21 tablets have been taken. You do not take the drug for the next 7 days. Menstruation (withdrawal bleeding) should begin within these 7 days. It usually starts 2-3 days after taking Janine’s last pill. After a 7-day break, start taking the tablets from the next pack, even if the bleeding has not stopped yet. This means that you will always start a new pack on the same day of the week, and that your withdrawal bleed will occur on approximately the same day of the week each month.
Reception of the first package of Janine
· When no hormonal contraceptive was used in the previous month
Start taking Janine on the first day of the cycle, that is, on the first day of menstrual bleeding. Take the pill that is marked with the corresponding day of the week. Then take the pills in order. You can also start taking it on days 2-5 of the menstrual cycle, but in this case you must use an additional barrier method of contraception (condom) during the first 7 days of taking the tablets from the first package.
· When switching from other combined oral contraceptives, vaginal ring or contraceptive patch
You can start taking Janine the day after you take the last tablet of the current package of combined oral contraceptive (ie, without taking a break). If the current package contains 28 tablets, you can start taking Janine the day after taking the last active tablet. If you are not sure which pill it is, ask your doctor. You can also start taking it later, but in no case later than the next day after the usual break in taking (for drugs containing 21 tablets) or after taking the last inactive tablet (for drugs containing 28 tablets in a package).
Taking Janine should begin on the day the vaginal ring or patch is removed, but no later than the day when a new ring is to be inserted or a new patch is applied.
· When switching from oral contraceptives containing only gestagen (mini-pills)
You can stop taking the mini-pill any day and start taking Janine the next day at the same time. During the first 7 days of taking the pills, you must also use an additional barrier method of contraception.
· When switching from an injectable contraceptive, an implant or from a progestogen-releasing intrauterine contraceptive (Mirena)
Start taking Janine on the day your next injection is due or on the day your implant or intrauterine device is removed. During the first 7 days of taking the pills, you must also use an additional barrier method of contraception.
· After childbirth
If you have just given birth, your doctor may recommend that you wait until the end of your first normal menstrual cycle before starting Janine. Sometimes, on the recommendation of a doctor, it is possible to start taking the drug earlier.
· After spontaneous miscarriage or abortion in the first trimester of pregnancy
Check with your doctor. It is usually recommended to start taking it immediately.
Taking missed pills
· If the delay in taking the next pill is less than 12 hours, the contraceptive effect of Zhanine remains. Take the pill as soon as you remember. Take your next pill at the usual time.
· If the delay in taking the pill is more than 12 hours, contraceptive protection may be reduced. The more pills in a row you miss, and the closer this skip is to the start of the dose or to the end of the dose, the higher the risk of pregnancy.
In this case, you can be guided by the following rules:
· Forgot more than one tablet from the package Consult your doctor.
· One tablet was missed in the first week of taking the drug
Take the missed pill as soon as you remember (even if this means taking two pills at the same time). Take your next pill at the usual time. Additionally, use a barrier method of contraception for the next 7 days. If sexual intercourse took place within a week before missing the pills, the possibility of pregnancy must be taken into account. Consult your doctor immediately.
· One tablet was missed in the second week of taking the drug
Take the missed pill as soon as you remember (even if this means taking two pills at the same time). Take your next pill at the usual time. If you have taken the pill correctly during the 7 days preceding the first missed pill, the contraceptive effect of Janine is maintained and you do not need to use additional contraceptive measures. Otherwise, as well as if you miss two or more tablets, you must additionally use barrier methods of contraception for 7 days.
· One tablet was missed during the third week of taking the drug
If all tablets have been taken correctly during the 7 days preceding the first missed pill, there is no need to use additional contraceptive methods. You can stick with either of the following two options
1. Take the missed pill as soon as you remember (even if this means taking two pills at the same time). Take the next pill at the usual time. Start the next pack immediately after finishing taking the pills from the current pack, so there is no break between packs. Withdrawal bleeding is unlikely until the tablets from the second package are finished, but spotting or breakthrough bleeding may occur on the days you take the drug.
2. Stop taking the tablets from the current package, take a break of 7 days or less (including the day you skipped the tablets) and then start taking the tablets from a new package.

Using this regimen, you can always start taking the pills from the next package on the day of the week when you usually do it.
If after a break in taking the tablets you do not get your expected menstruation, you may be pregnant. Consult your doctor before you start taking tablets from a new package.
In situations where you are advised to stop taking a combined oral contraceptive, or when the reliability of COCs may be reduced, you should abstain from sexual intercourse or use a non-hormonal method of contraception (such as a condom or other barrier methods). Rhythmic or temperature methods should not be used. These methods may be unreliable because... Taking COCs leads to changes in temperature and cervical mucus.
Recommendations in case of vomiting and diarrhea
If you have had vomiting or diarrhea (stomach upset) within 4 hours of taking Janine, the active ingredients may not have been completely absorbed. This situation is similar to skipping a drug dose. Therefore, follow the instructions for missed pills.
Delaying the onset of menstruation
You can delay the onset of menstruation if you start taking the tablets from the next package of Janine immediately after finishing the current package. You can continue taking the tablets from this pack for as long as you wish, or until the pack runs out. If you want your period to start, stop taking the tablets. While taking Janine from the second package, spotting or bleeding may occur on the days of taking the pills. Start the next pack after the usual 7-day break.
Changing the day your period starts
If you take the pills as recommended, you will have your period on approximately the same day every 4 weeks. If you want to change it, shorten (but do not lengthen) the period of time free from taking pills. For example, if your menstrual cycle usually starts on Friday, but in the future you want it to start on Tuesday (3 days earlier), the next pack should start 3 days earlier than usual. If the break from taking pills is very short (for example, 3 days or less), menstruation may not occur during the break. In this case, bleeding or spotting may occur while taking the pills from the next package.

Additional information for special categories of patients
Children and teenagers
The drug Zhanine is indicated only after the onset of menarche.
Elderly patients
Not applicable. The drug Zhanine is not indicated after menopause.
Patients with liver disorders
Zhanine is contraindicated in women with severe liver disease until liver function tests return to normal. See also section "Contraindications".
Patients with kidney problems
Zhanine has not been specifically studied in patients with renal impairment. Available data do not suggest changes in treatment in these patients.

Side effect

When taking combined oral contraceptives, irregular bleeding (spotting or breakthrough bleeding) may occur, especially during the first months of use.
While taking the drug Janine, other undesirable effects may occur, although their occurrence is not necessary in all patients.
Serious unwanted effects:
See sections "With caution" and "Special instructions". Please read these sections carefully and if you experience any unwanted effects, including serious drug-related reactions, consult your doctor.
Other undesirable effects identified during the study of the drug Janine:
Common undesirable effects (more than 1/100 and less than 1/10):
- headache;
- pain in the mammary glands, including discomfort in the mammary glands and engorgement of the mammary glands.
Infrequent adverse effects (more than 1/1000 and less than 1/100):
- vaginitis/vulvovaginitis (inflammation of the female genital organs);
- vaginal candidiasis (thrush) or other fungal vulvovaginal infections;
- increased appetite;
- decreased mood;
- dizziness;
- migraine;
- high or low blood pressure;
- abdominal pain (including pain in the upper and lower abdomen, discomfort/bloating);
- nausea, vomiting or diarrhea;
- acne;
- alopecia (hair loss);
- rash (including macular rash);
- itching (sometimes itching of the whole body);
Abnormal menstruation, including menorrhagia (heavy periods), hypomenorrhea (scanty periods), oligomenorrhea (irregular periods), and amenorrhea (absence of periods);
- intermenstrual bleeding, including vaginal bleeding and metrorrhagia (irregular bleeding between periods);
- an increase in the size of the mammary glands, including swelling and distension of the mammary glands;
- swelling of the mammary glands;
- dysmenorrhea (painful menstruation);
- vaginal discharge;
- ovarian cysts;
- pain in the pelvic area;
- fatigue, including asthenia (weakness) and malaise (fatigue, including weakness and general poor health);
- weight change (increase or decrease).
Rare undesirable effects (more than 1/10000 and less than 1/1000):
- adnexitis (inflammation of the fallopian (uterine) tubes and ovaries);
- urinary tract infections;
- cystitis (inflammation of the bladder);
- mastitis (inflammation of the mammary gland);
- cervicitis (inflammation of the cervix);
- candidiasis or other fungal infections;
- herpetic lesions of the oral cavity;
- flu;
- bronchitis;
- sinusitis;
- upper respiratory tract infections;
- viral infection;
- uterine fibroids (benign tumors in the uterus);
- breast lipoma (benign tumors of adipose tissue);
- anemia;
- hypersensitivity (allergic reactions);
- virilism (development of male secondary sexual characteristics);
- anorexia (severe loss of appetite);
- depression;
- mental disorders;
- insomnia;
- sleep disorders;
- aggression;
- ischemic stroke (reduced or suddenly stopped blood supply to part of the brain);
- cerebrovascular disorders (disorders of the blood flow system to the brain);
- dystonia (muscle tension (contractures) caused by an uncomfortable posture);
- dryness or irritation of the mucous membrane of the eyes;
- oscillopsia (impaired visual clarity, the illusion of vibration of stationary objects) or other visual disturbances;
- sudden hearing loss;
- noise in ears;
- dizziness;
- hearing impairment;
- cardiovascular disorders (impaired blood supply to the heart);
- tachycardia (rapid heartbeat);
- thrombosis (formation of a blood clot in blood vessels);
- pulmonary embolism (acute blockage of the branches of the pulmonary artery by blood clots);
- thrombophlebitis (inflammation of the venous wall with the formation of a blood clot in the lumen of the vein);
- increase in diastolic pressure (the minimum blood pressure indicator, corresponds to the pressure in the arterial vessels between heartbeats);
- orthostatic circular dystonia (feeling of dizziness, weakness or fainting when changing body position from sitting or lying to vertical);
- tides;
- phlebeurysm;
- vein pathology, pain in the vein area;
- bronchial asthma;
- hyperventilation;
- gastritis;
- enteritis;
- dyspepsia (digestion);
- skin reactions;
- skin pathology, including allergic dermatitis, neurodermatitis/atopic dermatitis, eczema, psoriasis;
- hyperhidrosis (excessive sweating);
- Chloasma (golden-brown pigment spots, so-called “pregnancy spots”, mainly on the face);
- pigmentation disorder/hyperpigmentation;
- seborrhea (oily skin);
- dandruff;
- hirsutism (male pattern hair growth);
- Orange peel;
- spider veins (expansion of subcutaneous vessels in the form of a mesh with a central red spot);
- back pain;
- discomfort in the muscles and bones of the skeleton;
- myalgia (muscle pain);
- pain in the arms and legs;
- cervical dysplasia (abnormal changes in the epithelium of the cervix);
- pain in the area of ​​the uterine appendages or cysts of the uterine appendages (ovaries and fallopian (fallopian) tubes);
- breast cysts;
- fibrocystic mastopathy (benign neoplasms in the mammary glands);
- dyspareunia (pain during sexual intercourse);
- galactorrhea (milk secretion);
- menstrual irregularities;
- chest pain;
- peripheral edema;
- flu-like conditions;
- inflammation.
Adverse effects identified during the study of the drug, the frequency of which is unknown: mood changes, increased or decreased libido, contact lens intolerance, urticaria, skin disorders (such as erythema nodosum or multiforme), breast discharge, fluid retention.
If you have hereditary angioedema, medicines containing certain female sex hormones (estrogens) may worsen symptoms (see Precautions section).
If any of the side effects become serious, or if you notice any side effects not listed in the instructions, please tell your doctor or pharmacist.
Overdose
No serious problems have been reported with a single dose of a large number of Janine tablets.
Symptoms that may occur in case of overdose: nausea, vomiting, spotting or vaginal bleeding.
In case of overdose, consult a doctor.

Interaction with other drugs

special instructions

The following warnings regarding the use of other combined oral contraceptives should also be taken into account when using Janine.
· Thrombosis
Thrombosis is the formation of a blood clot (thrombus) that can block a blood vessel. When a blood clot breaks off, thromboembolism develops. Sometimes thrombosis develops in the deep veins of the legs (deep vein thrombosis), vessels of the heart (myocardial infarction), brain (stroke), and extremely rarely in the vessels of other organs.
The risk of deep vein thrombosis in women taking combined oral contraceptives is higher than in those not using them, but not as high as during pregnancy.
The risk of developing thrombosis increases with age and also increases with the number of cigarettes smoked. When using Janine, you should stop smoking, especially if you are over 35 years old.
The risk of deep vein thrombosis temporarily increases during surgery or prolonged immobilization (immobilization), for example, when applying a cast to the leg, prolonged bed rest. If you are planning surgery or hospitalization, tell your doctor in advance that you are taking combined oral contraceptives. Your doctor may advise you to stop using the drug (if you are planning to have surgery, at least four weeks before it) and not to restart it for two weeks after your immobilization ends.
If your blood pressure is high, your doctor may recommend that you stop taking combined oral contraceptives.
Tumors
The connection between taking combined oral contraceptives and breast cancer has not been proven, although it is detected slightly more often in women taking combined oral contraceptives than in women of the same age who are not using them. This difference may be due to the fact that women are screened more often when taking the drug and therefore breast cancer is detected at an early stage.
In rare cases, during the use of sex steroids, the development of benign, and in extremely rare cases, malignant liver tumors, which can lead to life-threatening intra-abdominal bleeding, has been observed. The connection with the use of drugs has not been proven. If you suddenly experience severe abdominal pain, consult your doctor immediately.
The most significant risk factor for developing cervical cancer is persistent papilloma viral infection. Cervical cancer was detected slightly more often in women using combined oral contraceptives for a long period of time. The connection with the use of combined oral contraceptives has not been proven. This may be due to more frequent gynecological examinations to detect cervical diseases or to characteristics of sexual behavior (less frequent use of barrier methods of contraception).
Reduced efficiency
The effectiveness of combined oral contraceptives may be reduced in the following cases: missed pills, vomiting and diarrhea, or as a result of drug interactions.
Women with a tendency to chloasma while taking combined oral contraceptives, prolonged exposure to the sun and exposure to ultraviolet radiation should be avoided.
· In women with hereditary forms of angioedema exogenous estrogens may cause or worsen symptoms of angioedema

When to consult a doctor
Regular checkups
If you are taking Janine, your doctor will tell you to have regular checkups, at least once a year.
Consult your doctor as soon as possible:

• if you have any health changes, especially any of the conditions listed in this leaflet (see also Contraindications and Caution);
• with local compaction in the mammary gland; if you are going to use other medications (see also “Interactions with other medications”);
• if long-term immobility is expected (for example, the leg is in a cast), hospitalization or surgery is planned (check with your doctor at least 4 to 6 weeks in advance);
• if you experience unusual heavy vaginal bleeding;
• if you forgot to take a pill in the first week of taking the package and had sexual intercourse seven days before;
• you have missed your next period twice in a row or you suspect that you are pregnant (do not start taking the next pack until you have consulted your doctor).

The drug Zhanine is a hormonal microdosed1 monophasic2 combined3 oral4 contraceptive5

1 Microdosed – means that the estrogenic component in the drug is contained in a microdose. This allows you to minimize the risks of developing unwanted side effects and improve the tolerability of the drug.

2 Monophasic - means that one medicinal tablet contains a fixed (identical in each tablet) combination of active medicinal substances.

3 Combined - the drug contains two active substances (synthetic female sex hormones):

• Dienogest - hybrid progesterone - 2.0 mg
• Ethinyl estradiol – active estrogen in a microdose - 0.03 mg

4 Oral – the drug is taken orally in a convenient form, “per os - through the mouth,” i.e. The tablet must be swallowed with water.

5 Contraceptive means that the intended effect of the product is to protect a woman from unwanted pregnancy.

So, Janine, first of all, a hormonal contraceptive. But a number of additional advantages allow it to be used for the treatment of certain gynecological and other diseases: endometriosis, simple endometrial hyperplasia, acne, etc.

The drug Janine - box and blister

Endometriosis is a pathological benign process during which tissue similar to the endometrium begins to grow not in the uterine cavity, but where it should not be. For example: in the abdominal cavity, bladder, lungs, myometrium, ovaries, fallopian tubes, vagina...

Read more about endometriosis: its forms, symptoms, causes of development, diagnosis and treatment here

Endometriosis is an estrogen-dependent disease. Under the influence of cyclical fluctuations in the level of sex hormones, the same changes occur in the foci of endometriosis as in the mucous membrane of the uterus.

Wherever endometrioid tissue is located, during menstruation it “menstruates” - it becomes inflamed and bleeds, like the endometrium. During this period, the disease worsens: pelvic pain intensifies; menstruation becomes painful, prolonged, heavy; the functioning of organs affected by endometriosis is damaged. All this leads to poor health, loss of strength and ability to work for the suffering woman. Very often, endometriosis is accompanied by infertility.

Medicines from the COC group can relieve some pathological symptoms. Of all the COCs, Janine is recommended for the treatment of endometriosis.

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How does Janine work for endometriosis?

Zhanin's therapeutic mechanism is associated with the blockade of gonadotropic releasing factor (GnRH).

The principle of action of Zhanine for endometriosis: The drug daily introduces the same, strictly defined amount of sex steroids into the body. Consequently, hormonal “bursts” disappear and ovulation does not occur. No ovulation - no menstruation. Symptoms of the disease subside and remission occurs. The patient feels healthy.

By “leveling out” the hormonal levels, Janine plunges the woman’s reproductive system into a state of “medicinal rest.” The artificial period of “ovarian rest” is similar to the natural period of pregnancy or lactation. At this time, structural restructuring, degradation and atrophy of endometriosis foci occurs.

Along with antiproliferative properties, Janine has anti-inflammatory (inhibits the synthesis of prostaglandins - mediators of the pro-inflammatory cascade) and antiandrogenic effects.

The combination of strong progesterone and scanty estrogenic effects ensures good tolerability of the drug.

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The effectiveness of the drug Zhanine for endometriosis - reviews

Any hormonal therapy for endometriosis does not guarantee final recovery. The productivity of the mild therapeutic effects of COCs is quite low.

The effectiveness of treatment of minor forms of endometriosis by Janine is 58%

In what cases is treatment of endometriosis with this drug advisable? Indications for use of Zhanine for endometriosis:

• Suspicion of uterine endometriosis, i.e. There are symptoms of the disease, but there is no indisputable objective laboratory and instrumental confirmation of the disease.
• Minor forms of endometriosis.
• Mild endometriosis.
• Endometriosis of the uterus (adenomyosis) stages 1-2.
• Treatment of endometriosis-related pelvic pain.
• Dysmenorrhea.
• Prevention of secondary anemia associated with hyperpolymenorrhea.
• Prevention of disease relapse after surgical treatment of external genital endometriosis.
• As a maintenance treatment after completion of the GnRH A course.
• Restoring fertility.

Treatment of endometriosis by Janine

“Extended regimen” means that the medicine is taken over a long course, for 3-6-9 months to 1.5 years.

The hormonal drug Zhanine is used only as directed and under the supervision of a medical specialist with strict adherence to the individual dosage regimen

How much to drink Janine for endometriosis:

(doctor's consultation required)

Scheme: 42+7 In this case, Janine is taken for 42 days in a row, one tablet once a day.

Then a week break is taken (no need to take pills for 7 days).

After which the drug is taken again for 42 days in a row until the next 7-day break, etc.

If you take the pills every day, you will not get your period. Menstruation (withdrawal bleeding) occurs during a 7-day break from taking the medicine (in this case - once every 2 months).

Menstruation during the course of treatment with Janine is, as a rule, quite scanty. This indicates the effectiveness of therapy.

Again a 7-day break, etc.

How long to take Janine for endometriosis? The duration of the course of treatment is six months, nine months, a year... - prescribed by the attending physician.

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Janine - instructions for use for endometriosis

How to take Janine for endometriosis?

• 1 tablet 1 time per day at the same time, preferably in the evening after meals.
• Recommended dosage regimen for endometriosis: 63+7 (see above)

The first blister contains 21 tablets.

The release form of Janine is different:

• There are packages with 1 blister in 1 box.
• There are packages with 3 blisters in 1 box.

What to do if for some reason you did not take the pill on time? If the evening dose of the drug is missed, then the “forgotten” tablet should be taken in the morning of the next day. The next tablet is taken in the evening of the same day at the usual time.

What to do if, against the background of continuous use of Janine, “menstruation” suddenly begins? It happens that during the period of continuous use of pills, scanty spotting bloody discharge from the uterus or “breakthrough bleeding” similar to menstruation appears. At the same time, light menstruation occurs as expected - during the break between doses of the drug.

There is no need to be afraid of these phenomena. They do not pose any threat to health (let alone life) and do not mean that the treatment is ineffective. It is enough to address this problem to “your” gynecologist. If necessary, the doctor will adjust the individual dosage regimen.

In most cases, scanty intermenstrual bleeding does not require discontinuation of the drug and goes away on its own, after the body and uterine mucosa get used to the treatment.

Despite the high safety profile and good tolerability, the use of Janine (like any hormonal drug) has a number of limitations.

Absolute contraindications to taking Janine:

• Oncological diseases: any malignant or benign tumors, including carcinoma of the uterus and appendages.
• Pregnancy and breastfeeding.
• Thrombophlebitis, thrombosis, thromboembolism of veins, arteries of any location.
• Uncompensated or complicated by vascular pathology diabetes mellitus.
• Severe form of migraine.
• Uncompensated cardiovascular pathology.
• Uncompensated liver diseases.
• Intolerance (allergy) to any component of the drug.
• Psychopathology.

In other cases, Janine is prescribed by a gynecologist with the permission of the therapist after consultation with doctors of other specialties.

Patients with the following diseases (conditions) should take Zhanine with caution:

• Epilepsy.
• Obesity.
• Smoking.
• Diabetes.
• Pathology of the gastrointestinal tract.
• SLE, Crohn's disease.
• Phlebitis, arteritis.
• Hypertension.
• Tendency to angioedema.
• Atherosclerosis, lipid metabolism disorder.
• Sickle cell anemia.
• Multiple sclerosis.

If muscle spasms, swelling, severe pain in the limbs, severe headaches, intense chest pain, deterioration in visual acuity, or vomiting appear during treatment with Zhanine, you should stop taking the drug and immediately consult a doctor.

There are no direct contraindications to drinking alcohol. But ethyl alcohol is toxic. It worsens the tolerability of the drug, creates additional stress on the liver, and can provoke negative (sometimes fatal) conditions. In addition, drinking alcohol is one of the factors that increases the risk of developing endometriosis. Therefore, any woman should give up alcohol in principle.

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Advantages and disadvantages of Janine for endometriosis

• Today, Janine is the only COC with the progesterone component Dienogest. It is Dienogest that is recommended by WHO experts as the first choice progestogen for the treatment of endometriosis.
• The bioavailability of Dienogest when administered orally is 90%, which is several times higher than that of progesterone components and other COCs.
• Antiandrogenic effect of Dienogest: - provides Janine with additional bonuses that are beneficial for the female body: treats acne, blackheads, oily seborrhea, improves the general condition of the skin and hair, etc.

  Eliminates the undesirable effects associated with androgenic influence: does not affect body weight, does not increase blood pressure, does not worsen the lipid profile, etc.

• According to German specialists, it is the drug Valletta, registered in Russia as Zhanine, that is ideal for oral contraception for women with endometriosis.

To prescribe Zhanin for endometriosis, laparoscopic or histological confirmation of the diagnosis is not required.

• The therapeutic effect of Janine in the case of endometriosis is much lower than that of.
• Janine cannot be an alternative to surgical treatment of the disease.

By and large, for endometriosis, Janine is used as a supportive, anti-relapse and preventive agent in the complex treatment of the disease.

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Janine and pregnancy after taking

Janine, as mentioned above, is a contraceptive. Accordingly, you cannot become pregnant while taking it.

At the same time, Janine does not have any negative effects on a woman’s fertility, and in some cases even restores it. You can try to get pregnant immediately after finishing the course of treatment with the drug.

Sometimes it may take several months for the menstrual cycle to fully return. After which the desired pregnancy occurs without difficulty.

If this does not happen, you should consult a doctor to find out and eliminate the causes of infertility unrelated to the retrospective use of Janine.

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Endometriosis of the uterus: symptoms and treatment Endometriosis of the uterus - simply about the complex 10/08/2017 (Updated: 11/22/2017)

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Treatment of endometriosis by Janine

The hormonal drug Janine is an oral drug for the prevention of unwanted pregnancy and for the treatment of endometriosis. Most often, to eliminate this disease, doctors prescribe special treatment regimens. But here you need to carefully listen to your feelings, recording side effects. They may indicate that the drug is contraindicated. According to many experts, Janine is the safest for endometriosis, since it does not affect the ability to conceive.

The drug contains two active components: estrogen itself in the form of ethinyl estradiol (30 mcg) and gestagen (dienogest in a dosage of 2 mg).

A product with such active substances does not have a harmful effect, but only stimulates the natural functioning of the woman’s body. When Janine enters the body, the following occurs:

• suppression of ovulation;
• complication of sperm entry due to poor patency of the cervix;
• normalization of the menstrual cycle (elimination of pain, reduction in the volume of blood discharge, regulation);
• decrease in the content of androgenic hormones in the body.

Use for endometriosis

In fact, Janine has one general indication - protection against unwanted pregnancy. But trials have shown that it also treats endometriosis. The disease can cause infertility, and the drug helps to avoid this. At the same time, the therapeutic effect of the drug is quite great.

Sometimes this remedy is used (it contains not one active ingredient, but several at once) when therapy with other drugs does not bring the desired result. Zhanine does not produce any significant side effects in the treatment of endometriosis. It is important to use it as directed in the instructions for use.

Indications for use

The drug is prescribed for the following purposes:

• normalization of the menstrual cycle;
• eliminating pain from endometriosis;
• treatment of endometrial hyperplasia;
• normalization of hormonal levels after surgical interventions related to the treatment of endometriosis;
• acne treatment;
• improving the functioning of the ovaries with cystic formations.

Like any other hormonal drugs, the drug has a number of side effects, so you should first consult with a specialist and adjust the dosage. Whether a woman intends to become a mother in the near future or not can also play a role in selecting a course of treatment.

It is better to start drinking Janine from the first day of the new cycle.

Contraindications

Possible side effects of taking Janine for endometriosis include the following:

• change in stool character;
• allergic manifestations on the skin;
• intolerance to contact vision correction agents;
• inconstancy of emotions;
• migraine-like headaches;
• cholestatic jaundice;
• thrombosis, myocardial infarction, liver, kidney;
• thrombophlebitis of veins;
• strokes;
• spotting from the vagina, similar to menstruation;
• hyperrexia;
• soreness of the mammary glands, their swelling.

If all the doctor’s recommendations are followed exactly, such symptoms are very likely not to occur. Those who have a smoking habit should especially pay attention to their health. This applies to a greater extent to women over 35 years of age. If you have bad habits at this age, the risk of thrombosis increases significantly.

There are also some contraindications. These include:

• arterial hypertension;
• diabetes;
• thromboembolic diseases (even if they were in the past);
• cancer of the reproductive system related to hormonal levels;
• serious liver diseases;
• cholelithiasis;
• epileptic seizures;
• migraine.

Drug interactions

Like any other contraceptives, Jeannine is incompatible with drugs that cause oxidative biochemical reactions in the liver (for example, carbamzepine, barbiturates, rifampicin, tetracycline antibiotics). Taking them with Janine at the same time may cause a decrease in the therapeutic effect against endometriosis. The contraceptive effect also decreases.

Siluet, which has the same active substances, can work as an analogue of the drug. They can completely replace Janine.

When to consult a doctor during treatment

Those taking the drug should immediately consult a doctor if the following symptoms occur:

• the occurrence of swelling of the arms and legs;
• increased blood pressure;
• unauthorized withdrawal of the drug for more than a week;
• severe uterine bleeding;
• fainting, dizziness;
• absence of menstrual-like discharge during discontinuation of the drug Janine;
• breast tightness, swelling of the mammary glands.

This may indicate additional diseases or that the medicine is not suitable for the woman.

Previously, endometrial diseases were treated only surgically, but now it is enough to take a course of Janine, and endometriosis will recede. This is one of the most proven and safe means for treating the disease and implementing contraception. It does not include too many contraindications and side effects. The drug has a hormonal structure, so a doctor can prescribe it based on the patient’s health condition. A specialist should also explain how to take Janine and how long to take the course.

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"Janine": instructions for use

The drug "Zhanine" is prescribed to prevent pregnancy. The product also helps to smooth out the menstrual cycle, which can make them less painful. The drug should be taken on the first day of menstruation, provided that no other oral contraceptives were used in the previous month. If you need to switch to “Janine”, it should be used immediately after taking the last tablet of the previous contraceptive.

After taking the drug "Zhanine", bleeding becomes less intense, this reduces the likelihood of anemia. Tablets "Zhanine" should be taken once a day, at the same time. The course of treatment lasts 21 days, after which a break is taken for 7 days, at which time menstruation should begin. You should not skip taking the drug. If this happens, you must take the tablet within the next twelve hours. Then continue the usual intake of the drug.

If you miss a pill in the first week for more than 12 hours, in order to avoid getting pregnant, you should additionally use barrier methods of contraception over the next week. If you miss taking the drug in the second week (provided that the drug was taken as scheduled in the first week), additional contraceptives do not need to be used. If you miss a pill in the third week, you can do the following: start taking the next pack without taking a week's break; or stop taking the drug, take a seven-day break, including the day you missed the pill, and then start a new pack.

Side effects, contraindications to the use of the drug "Zhanin"

The drug "Janine" can cause the following side effects: pain, tension and breast enlargement, discharge from the mammary glands, migraine, bloody spotting vaginal discharge, mood swings, changes in libido, blurred vision, lens intolerance, vomiting, nausea, abdominal pain, diarrhea , fluid retention, weight change, jaundice, allergies, itching, rash.

If after taking “Janine” diarrhea or vomiting begins within the next 4 hours, you need to take care of additional contraception and follow the recommendations when skipping pills.

"Zhanine" is contraindicated in case of vaginal bleeding of unknown origin, thrombosis, migraine, diabetes mellitus with vascular complications, liver failure, pancreatitis, malignant hormone-dependent formations, if pregnancy is suspected, during pregnancy, lactation, with detected hypersensitivity, during leg operations, extensive injuries, serious surgical interventions.

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Janine

The contraceptive effect of combined oral contraceptives (COCs) is based on the interaction of various factors, the most important of which are suppression of ovulation and changes in cervical secretion. In addition to preventing pregnancy, PDAs have a number of other positive properties that can be used when choosing a method of contraception. The menstrual cycle becomes more regular, menstruation becomes less painful, and blood loss decreases. The latter reduces the incidence of iron deficiency anemia.

The progestogenic component of the drug Janine, dienogest, is a strong progestogen and is considered the only norethisterone derivative with antiandrogenic properties. The presence of an antiandrogenic effect has been proven in clinical studies involving a limited number of patients with the inflammatory form of acne vulgaris. Dienogest has a positive effect on the lipid profile, while the HDL content increases. There is evidence of a reduced risk of endometrial and ovarian cancer. In addition, it has been proven that when using COCs in high doses (50 mcg ethinyl estradiol), the risk of ovarian cysts, pelvic inflammatory diseases, benign breast diseases and ectopic pregnancy is reduced.

Standard preclinical studies of repeated dose toxicity, genotoxicity, carcinogenicity and reproductive toxicity do not indicate any specific risk to humans. However, it should be noted that sex steroids may promote the growth of certain hormone-dependent tissues and pre-existing tumors.

Dienogest

After oral administration, dienogest is rapidly and completely absorbed. The maximum serum concentration is reached within 2.5 hours after a single oral dose and is approximately 51 pkg/ml. The absolute bioavailability of dienogest after oral administration is 96%.

Dienogest binds to serum albumin and does not bind to sex hormone binding globulin (SHBG) or corticoid binding globulin (CBG). Only 10% of the total serum concentration of dienogest is in the form of a free steroid, and 90% is nonspecifically bound to albumin. The increase in SHBG levels induced by ethinyl estradiol does not affect the binding of dienogest to serum proteins.

Dienogest is completely metabolized primarily by hydroxylation and conjugation to form inactive metabolites. These metabolites are quickly cleared from the blood plasma so that not a single active metabolite is detected in it, but only dienogest in an unchanged state. The total clearance is about 3.6 l/h after a single use.

The level of dienogest in the blood serum decreases with a half-life of 8.5–10.8 hours. Only a small part of dienogest is excreted unchanged by the kidneys. Metabolites are excreted in urine and bile in a ratio of about 3:1. The half-life is approximately 14.4 hours.

The pharmacokinetics of dienogest are independent of SHBG levels. When taken daily, the concentration of the substance in the blood serum increases 1.3 times, reaching a steady state during the first half of the treatment cycle.

Ethinyl estradiol

When taken orally, ethinyl estradiol is rapidly and completely absorbed. Peak serum concentrations of approximately 67 pg/ml are achieved within 1.5–4 hours.

Ethinyl estradiol binds tightly but not specifically to serum albumin (approximately 98%) and increases serum SHBG concentrations.

Ethinyl estradiol is metabolized mainly by aromatic hydroxylation, however, a large number of hydroxylated and methylated metabolites are additionally formed, including both free metabolites and conjugates with glucuronides and sulfates. Clearance is 2.3–7 ml/min/kg body weight.

Serum ethinyl estradiol levels decrease in 2 phases with half-lives of about 1 hour and 10–20 hours, respectively. The substance is not excreted from the body unchanged; ethinyl estradiol metabolites are excreted in urine and bile in a ratio of 4:6. The half-life of metabolites is approximately 1 day.

Based on variable serum half-life and daily dosing, steady-state serum concentrations of ethinyl estradiol are achieved in approximately 1 week.

Indications

Contraception.

Application

The pills should be taken daily according to the order indicated on the blister, at approximately the same time, with a small amount of liquid. The drug is taken 1 tablet per day for 21 days. Taking pills from each subsequent package should begin after the end of a 7-day break in taking the drug, during which, as a rule, menstrual-like bleeding occurs, which usually begins on the 3rd day after taking the last pill and may not end before the start of taking pills from next package.

If hormonal contraceptives were not used in the previous period (last month)

Taking pills should start on the 1st day of the menstrual cycle. You can start taking it from days 2–5, but in this case, during the first cycle, it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the drug.

Switching from another combined oral contraceptive (COC)

It is advisable to start taking Janine the day after taking the last active tablet of the previous COC, at least not later than the next day after a break in taking tablets or after taking placebo tablets of the previous COC.

Switching from a method based on the use of progestogen only (mini-pills, injections, implants) or an intrauterine system with progestogen.

You can start taking Janine any day after you stop taking the mini-pill (in the case of an implant or intrauterine system - on the day of their removal; in the case of an injection - instead of the next injection). However, in all cases it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the pill.

After an abortion in the first trimester of pregnancy

You can start using the drug Janine immediately. In this case, there is no need to use additional contraception.

After childbirth or abortion in the second trimester of pregnancy

In case of breastfeeding (see subsection “Pregnancy and breastfeeding”), it is recommended to start taking the drug Zhanine from the 21st to 28th day after childbirth or abortion in the second trimester of pregnancy. If you start taking the pill later, you should additionally use a barrier method of contraception during the first 7 days of taking the drug. However, if sexual intercourse has already taken place, then before starting to use the PDA it is necessary to exclude a possible pregnancy or wait until menstruation.

What to do if you miss a pill dose

If the delay in taking the pill does not exceed 12 hours, the effectiveness of the contraceptive effect of the drug is not reduced. The missed pill should be taken as soon as possible. The next pill from this package is taken at the usual time.

If the delay in taking the missed pill exceeds 12 hours, contraceptive protection may decrease. In this case, you can follow two basic rules:

The break in taking the pills can never exceed 7 days;

Adequate suppression of the hypothalamus-pituitary-ovarian system is achieved by continuous intake of the pill for 7 days.

Accordingly, the following recommendations should be followed in daily life:

1st week

The last missed pill must be taken as soon as possible, even if you have to take 2 pills at the same time. After this, continue to take the pills at the usual time. In addition, over the next 7 days you must use a barrier method of contraception, such as a condom. If sexual intercourse took place in the previous 7 days, the possibility of pregnancy should be considered. The more pills you miss and the closer the break in taking the drug, the higher the likelihood of pregnancy.

2nd week

It is necessary to take the last missed pill as soon as possible, even if you have to take 2 pills at the same time. After this, continue to take the pills at the usual time. If you take the tablets correctly for 7 days before the first missed period, there is no need to use additional contraceptives. In another case or if more than 1 tablet is missed, it is recommended to additionally use a barrier method of contraception for 7 days.

3rd week

The risk of decreased reliability increases as the break in taking the pill approaches. However, if you follow the regimen for taking pills, you can avoid a decrease in contraceptive protection. If you adhere to one of the following options, then there will be no need to use additional contraceptives, provided you take the tablets correctly for 7 days before the missed period. If this is not the case, you should stick to the first option below and use additional methods of contraception for the next 7 days.

It is necessary to take the last missed pill as soon as possible, even if you have to take 2 pills at the same time. After this, continue to take the pills at the usual time. Dragees from the next package should be taken immediately after the end of the previous one, that is, there should be no breaks. It is unlikely that menstrual bleeding will begin by the end of the second pack, although spotting or breakthrough bleeding may occur while taking the pills.

You may also be advised to stop taking the tablets from the current package. In this case, the break in taking the drug should be up to 7 days, including days of missing pills; You should start taking the pills from the next package.

If you miss taking a pill and there is no menstrual bleeding during the first regular break in taking the pill, you should exclude the possibility of pregnancy.

In case of severe gastrointestinal disorders, incomplete absorption of the drug is possible; in this case, additional contraception should be used.

If vomiting occurs within 3-4 hours after taking the pills, it is advisable to use the recommendations regarding skipping pills. If the patient does not want to change her usual regimen of taking the drug, she needs to take additional pill(s) from a different package.

How to change the timing of your period or how to delay your period

To delay the appearance of menstruation, you should continue to take Janine tablets from a new package and not take a break from taking the drug. If desired, the period of administration can be continued until the end of the second package. In this case, breakthrough bleeding or spotting cannot be ruled out. The usual intake of the drug Janine is restored after a 7-day break from taking the pills.

To shift the onset of menstruation to another day of the week, it is recommended to shorten the break in taking pills by the desired number of days. It should be noted that the shorter the break, the more often the absence of menstrual-like bleeding and breakthrough bleeding or spotting is noted while taking the pills from the second package (as in the case of delayed menstruation).

Contraindications

COCs should not be used if you have at least one of the following conditions or diseases. If any of these conditions or diseases occur for the first time while using a COC, the drug should be stopped immediately.

Venous or arterial thrombotic/thromboembolic events (eg deep vein thrombosis, pulmonary embolism, myocardial infarction) or cerebrovascular disorders, current or in history.

The presence or history of prodromal symptoms of thrombosis (for example, transient cerebrovascular accident, angina pectoris).

History of migraine with focal neurological symptoms.

Diabetes mellitus with vascular damage.

The presence of severe or multiple risk factors for venous or arterial thrombosis may also be a contraindication (see SPECIAL INSTRUCTIONS).

Current or history of pancreatitis if associated with severe hypertriglyceridemia.

Current or history of severe liver disease until liver function tests return to normal.

Diagnosed or history of liver tumors (benign or malignant).

Diagnosed or suspected malignant tumors (for example, genital or breast tumors) that are dependent on sex hormones.

Vaginal bleeding of unknown etiology.

Diagnosed or suspected pregnancy.

Hypersensitivity to the active substances or to any of the components of the drug.

Side effects

The most serious side effects associated with the use of COCs are described in the USES section.

Other undesirable effects have been reported with the use of COCs, but their connection with the use of COCs has been neither confirmed nor refuted:

special instructions

If any of the following conditions/risk factors are present, the benefits of using COCs should be assessed against the possible risks, taking into account the individual characteristics of each patient and discussed with her before she decides to take COCs. If any of the following conditions or risk factors become worse, worse, or occur for the first time, it is recommended that you consult your doctor. The doctor must decide whether to stop using the COC.

Circulatory disorders

Based on the results of epidemiological studies, there is an association between the use of COCs and an increased risk of venous, arterial, thrombotic and thromboembolic diseases, such as myocardial infarction, stroke, deep vein thrombosis and pulmonary embolism. These conditions occur rarely.

Venous thromboembolism (VTE), manifested as venous thrombosis and/or pulmonary embolism, can occur with the use of any COC. The risk of venous thromboembolism is highest during the 1st year of COC use. The incidence of VTE in women taking oral contraceptives with low-dose estrogens (≤0.05 mg ethinyl estradiol) is up to 4 cases per 10,000 women/year compared with 0.5–3 cases per 10,000 women/year in women not using oral contraceptives. The incidence of VTE associated with pregnancy is 6 cases per 10,000 women/year.

Thrombosis of other blood vessels, such as arteries and veins of the liver, kidneys, mesenteric vessels, cerebral or retinal vessels, has been extremely rarely reported in women using COCs. There is no consensus regarding the connection between these complications and the use of PDAs.

Symptoms of venous or arterial thrombotic/thromboembolic events or stroke may include: unilateral lower extremity pain or swelling; sudden severe chest pain radiating to the left arm; sudden shortness of breath; sudden onset of cough; any unusual, severe, prolonged headache; sudden decrease or complete loss of vision; diplopia; speech impairment or aphasia; vertigo; collapse with or without partial epileptic seizure; weakness or very severe sudden numbness of one side or one part of the body; motor impairment; acute stomach

Factors that increase the risk of venous or arterial thrombotic/thromboembolic events or stroke:

Age;

Tobacco smoking (in combination with heavy smoking and with age, the risk increases, especially in women over 35 years of age);

Family history (for example, cases of venous or arterial thromboembolism in siblings or parents at a relatively early age). If a hereditary predisposition is suspected, the woman should be referred for consultation to an appropriate specialist before making a decision on the use of any PDA;

Obesity (body mass index more than 30 kg/m2);

Dyslipoproteinemia;

Hypertension;

Migraine;

Heart valve pathology;

Atrial fibrillation;

Prolonged immobilization, radical surgical interventions, any surgical operations on the lower extremities, significant injuries. In these cases, it is recommended to stop using the COC (for planned operations at least 4 weeks before they are performed) and not restore it earlier than 2 weeks after complete remobilization.

There is no consensus regarding the possible role of varicose veins and superficial thrombophlebitis in the development of venous thromboembolism.

It is necessary to take into account the increased risk of thromboembolism in the postpartum period.

Other diseases that may be associated with serious circulatory disorders include diabetes mellitus; systemic lupus erythematosus; hemolytic uremic syndrome; chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell anemia.

An increased incidence of migraine or its exacerbation during the period of use of COCs (which may be a harbinger of cerebrovascular accident) may require urgent cessation of COC use.

Biochemical indicators characteristic of hereditary or acquired susceptibility to venous or arterial thrombosis include: resistance to CRP, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies).

When analyzing the risk/benefit ratio, the physician should take into account that adequate treatment for the conditions mentioned above can reduce the associated risk of thrombosis, and also that the risk of thrombosis associated with pregnancy is higher than with the use of COCs in low doses (≤0.05 mg ethinyl estradiol).

The most important risk factor for the development of cervical cancer is the persistence of papillomavirus. The results of epidemiological studies indicate an additional increase in this risk with long-term use of COCs. This statement is controversial because the extent to which the studies account for associated risk factors, such as cervical smear testing and sexual behavior, including the use of barrier methods of contraception, is unclear.

The results of a meta-analysis based on data from 54 epidemiological studies indicate a slight increase in the relative risk (RR = 1.24) of developing breast cancer in women using COCs. This increased risk gradually disappears within 10 years of stopping taking COCs. Because breast cancer is rarely diagnosed in women under 40 years of age, the increase in breast cancer diagnosis among current or recent COC users is small relative to the overall risk of breast cancer. The results of these studies do not provide evidence of a causal relationship. The increased risk may be due to both earlier diagnosis of breast cancer in women using COCs, the biological effects of COCs, or a combination of both factors. There is a tendency that breast cancer detected in women who have ever taken COCs is clinically less severe than in those who have never taken COCs.

In isolated cases, benign, and even less often, malignant liver tumors were noted in women using COCs, which sometimes led to the development of life-threatening intra-abdominal bleeding. If there are complaints of severe pain in the epigastric region, liver enlargement, or signs of intra-abdominal bleeding, the differential diagnosis should take into account the possibility of a liver tumor in women taking COCs.

Other conditions

Women with hypertriglyceridemia or a family history of this disorder are at risk of developing pancreatitis when using COCs.

Although slight increases in blood pressure have been reported in many women taking COCs, clinically significant increases in blood pressure are rare. However, if prolonged, clinically significant hypertension occurs while taking a COC, it may sometimes be more appropriate to discontinue the COC and treat the hypertension.

The occurrence or exacerbation of the following diseases has been reported during pregnancy and with the use of COCs, but their relationship with the use of COCs has not been conclusively established: jaundice and/or pruritus associated with cholestasis, gallstone formation, porphyria, systemic lupus erythematosus, hemolytic uremic syndrome, Sydenham's chorea, herpes of pregnancy, hearing loss associated with otosclerosis.

In acute or chronic liver dysfunction, it may be necessary to stop taking COCs until liver function tests return to normal. If cholestatic jaundice relapses, which first occurred during pregnancy or previous use of sex hormones, taking COCs should be discontinued.

Although COCs may affect peripheral insulin resistance and glucose tolerance, there are no data regarding the need to change the therapeutic regimen in women with diabetes mellitus taking low-dose COCs (containing ≤0.05 mg ethinyl estradiol). However, women with diabetes should be closely monitored while taking COCs.

Crohn's disease and ulcerative colitis may be associated with COC use.

Chloasma can sometimes occur, especially in women with a history of chloasma during pregnancy. Those prone to chloasma should avoid exposure to direct sunlight or ultraviolet radiation while taking COCs.

Medical examination

Before starting or reinstating the use of the drug Zhanine, a full medical examination should be performed and the patient’s medical history should be studied in detail, taking into account contraindications (see CONTRAINDICATIONS) and warnings (see APPLICATION). When using COCs, it is recommended to conduct periodic examinations, which is very important, since contraindications (for example, transient circulatory disorders, etc.) or risk factors (for example, a family history of venous or arterial thrombosis) may first appear during the period of taking COCs. The frequency and nature of these examinations should be based on the standards of medical practice, taking into account the individual characteristics of each woman, however, special attention is paid to the examination of the pelvic organs, including a standard analysis of cytology of the cervix, abdominal organs, mammary glands, and determination of blood pressure.

The patient must be warned that oral contraceptives do not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Reduced efficiency

The effectiveness of combined oral contraceptives may be reduced if you miss a pill, have gastrointestinal problems, or use other medications.

Cycle control

When taking oral contraceptives, intermenstrual bleeding (spotting or breakthrough bleeding) may occur, especially during the first few months of treatment. Taking this into account, examination in the event of any intermenstrual bleeding should be carried out only after a period of adaptation of the body to the drug, which is approximately 3 cycles.

If menstrual irregularities continue or recur after several normal cycles, non-hormonal causes of bleeding should be considered and appropriate investigations should be carried out to exclude the presence of tumors and pregnancy. Diagnostic measures can include curettage.

Some patients may not experience menstrual bleeding during a break in taking the drug. Pregnancy is unlikely when you take COCs as directed. However, if the contraceptive is taken irregularly or if menstrual-like bleeding is absent for 2 cycles, pregnancy must be excluded before continuing to take the COC.

During pregnancy and breastfeeding

The drug is contraindicated for use during pregnancy. If pregnancy occurs during the period of use of the drug Zhanine, the drug should be discontinued. However, research results do not indicate an increased risk of congenital pathologies in children born to mothers who took COCs during pregnancy, nor do they indicate the existence of a teratogenic effect when unintentionally taking COCs in early pregnancy.

PDAs can affect lactation, since under their influence the amount of breast milk can decrease and also change its composition. With this in mind, COCs are not recommended for use while breastfeeding.

The active substances included in the drug and/or their metabolites are excreted in small quantities into breast milk, but there is no data on their negative effect on the health of the infant.

Impact on the ability to drive vehicles and operate machinery

No effect noted.

Interactions

Interactions between oral contraceptives and other drugs may result in breakthrough bleeding and/or loss of contraceptive effectiveness. The following interactions have been reported in the literature.

Hepatic metabolism: possible interaction with drugs that induce microsomal enzymes, which can lead to an increase in the clearance of sex hormones (for example, phenytoin, barbiturates, primidone, carbamazepine, rifampicin and possibly also oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin and drugs containing St. John's wort).

Interaction with the enterohepatic circulation: Some clinical studies suggest that the enterohepatic circulation of estrogens may be decreased by certain antibiotics that reduce ethinyl estradiol concentrations (such as penicillin and tetracycline antibiotics).

When treating with any of the above drugs, you should temporarily use a barrier method in addition to taking COCs or choose another method of contraception. When treating with drugs that induce microsomal enzymes, the barrier method should be used throughout the entire period of treatment with the corresponding drug and for another 28 days after stopping its use. When treating with an antibiotic (with the exception of rifampicin and griseofulvin), the barrier method should be used for another 7 days after discontinuation of the antibiotic. If the barrier method is still being used, and the tablets in the PDA package have already run out, taking the tablets from the next package should be started without the usual break.

Oral contraceptives may affect the metabolism of other drugs. Taking this into account, the concentrations of active substances in blood plasma and tissues (for example, cyclosporine) may change.

Note. To determine the potential for interaction with drugs that are prescribed concomitantly with COCs, it is recommended that you read the instructions for medical use of these drugs.

Impact on laboratory results

Taking contraceptives may affect the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and kidney function, plasma proteins (carriers), such as sex hormone binding globulin and lipid/lipoprotein fractions, parameters carbohydrate metabolism, as well as parameters of coagulation and fibrinolysis.

Overdose

No serious adverse effects due to overdose have been reported. The following symptoms of overdose may occur: nausea, vomiting, and in young patients, slight bleeding from the vagina. There are no specific antidotes; treatment should be symptomatic.

Janine: instructions for use and reviews

Latin name: Jeanine

ATX code: G03AA

Active substance: ethinylestradiol + dienogest (ethinylestradiol + dienogest)

Manufacturer: Bayer Weimar GmbH and Co. KG (Bayer Weimar, GmbH & Co. KG) (Germany)

Updating the description and photo: 20.08.2019