Жанин®

General characteristics. Structure:

Active components: ethinylestradiol of 0,03 mg and диеногест 2,0 mg.
Excipients: lactoses monohydrate, potato starch, gelatin, talc, magnesium stearate, sucrose, dextrose (glucose syrup), macrogoal 35000, calcium carbonate, K25 povidone, titanium dioxide (Е 171), wax of karnaubskiya.
Description. White smooth dragees.

Pharmacological properties:

Pharmacodynamics. Jeanine - the combined estrogen-gestagenny low-dosed monophase peroral contraceptive drug.
The contraceptive effect of Zhanin is carried out by means of complementary mechanisms suppression of an ovulation and change of viscosity of cervical slime therefore it becomes impenetrable for spermatozoa concern to the most important of which.
At the correct use Perl's index (the indicator reflecting number of pregnancies at 100 women accepting a contraceptive within a year) makes less than 1. At the admission of tablets or the wrong use Perl's index can increase.
The Gestagenny component of Zhanin - диеногест - has anti-androgenic activity that is confirmed with results of a number of clinical trials. Besides, диеногест improves a blood lipid profile (increases quantity of lipoproteids of high density).
At the women accepting the combined oral contraceptives, the menstrual cycle becomes more regular, painful periods are less often observed, intensity and duration of bleeding therefore the risk of an iron deficiency anemia decreases decreases. Besides, there are data on decrease in risk of development of endometrial cancer and ovarian cancer.

Pharmacokinetics.

• Диеногест Absorption. At oral administration диеногест it is quickly and completely absorbed, its maximum concentration in blood serum, equal 51 ng/ml, is reached approximately in 2,5 hours. Bioavailability makes about 96%.
Distribution. Диеногест contacts albumine of blood serum and does not contact the globulin, connecting sexual steroids (G,CSS) and the kortikoid-connecting globulin (KSG). In a free look there are about 10% of the general concentration in blood serum; about 90% - are not specifically connected with a seralbumin. Induction by ethinylestradiol of synthesis of GSPS does not influence linkng of a diyenogest with a serumal protein.
Metabolism. Диеногест it is almost completely metabolized. The clearance after reception of a single dose makes about 3.6 l/h of serum.
Removal. The elimination half-life makes about 8,5-10,8 h. The insignificant quantity in not changed form is removed by kidneys in the form of metabolites (an elimination half-life - 14,4 h) which are removed by kidneys and through digestive tract in the ratio about 3:1.
Equilibrium concentration. The pharmacokinetics of a diyenogest is not influenced by the GSPS level in blood serum. As a result of daily administration of drug substance level in serum increases approximately by 1,5 times.
• Ethinylestradiol
Absorption. After intake ethinylestradiol is quickly and completely absorbed. The maximum concentration in blood serum, equal about 67 pg/ml, is reached in 1,5-4 hours. During absorption and the first passing through a liver ethinylestradiol is metabolized therefore its bioavailability at intake averages about 44%.
Distribution. Ethinylestradiol almost completely (about 98%), though it is not specific, communicates albumine. Ethinylestradiol induces synthesis of GSPG. The seeming volume of distribution of ethinylestradiol is equal to 2,8 - 8,6 l/kg.
Metabolism. Ethinylestradiol is exposed to presistemny conjugation, both in mucous a small bowel, and in a liver. The main way of metabolism - an aromatic hydroxylation. Clearance speed makes 2,3 - 7 ml/min. of a blood plasma.
Removal. Reduction of concentration of ethinylestradiol in blood serum has two-phase character; the first phase is characterized by an elimination half-life about 1 hour, the second — 10-20 hours. In not changed view from an organism it is not removed. Metabolites of ethinylestradiol are removed with urine and bile in the ratio 4: 6 with an elimination half-life about 24 h.
Equilibrium concentration. Equilibrium concentration is reached throughout the second half of a medical cycle.

Indications to use:

Contraception.

Route of administration and doses:

The dragee should be accepted inside on the order specified on packaging, every day approximately at the same time with a small amount of water. Accept on one dragee a day continuously within 21 days. Reception of the following packaging begins after a 7-day break in reception of a dragee during which cancellation bleeding usually develops. Bleeding, as a rule, begins for 2-3 day after reception of the last dragee and can not end prior to reception of a dragee from new packaging.
How to begin Zhanin's reception
• In the absence of reception of any hormonal contraceptives last month.
Zhanin's reception begins in the first day of a menstrual cycle (i.e. in the first day of menstrual bleeding). The beginning of reception for 2-5 day of a menstrual cycle is allowed, but in this case it is recommended to use in addition a barrier method of contraception during the first 7 days of reception of a dragee from the first packaging.
• Upon transition from other combined hormonal contraceptives (the combined oral contraceptives (COOK), a vaginal ring, a transdermalny plaster).
It is preferable to begin Zhanin's reception next day after reception of the last active dragee from the previous packaging, but by no means no later than the next day after a usual 7-day break (for the drugs containing 21 tablets) or after reception of the last inactive tablet (for the drugs containing 28 tablets in packaging). Upon transition from a vaginal ring, a transdermalny plaster it is preferable to begin Zhanin's reception in day of removal of a ring or plaster, but no later than day when the new ring has to be entered or the new plaster is pasted.
• Upon transition from the contraceptives containing only gestagena ("mini-drank", injection forms, an implant) or from the intrauterine contraceptive (Mirren) releasing гестаген.
The woman can pass with mini-saw on Jeanine in any day (without interruption), from an implant or an intrauterine contraceptive with gestageny - in day of its removal, from an injection form - from the date of when the following injection would have to be made. In all cases it is necessary to use in addition barrier method of contraception during the first 7 days of reception of a dragee.
• After abortion in the first trimester of pregnancy.
The woman can begin administration of drug immediately. At observance of this condition the woman does not need additional contraceptive protection.
•  After the delivery or abortion in the second trimester of pregnancy.
It is recommended to begin administration of drug for 21-28 day after the delivery or abortion in the second trimester of pregnancy. If reception is begun later, it is necessary to use in addition barrier method of contraception during the first 7 days of reception of a dragee. However if the woman already led sex life, prior to Zhanin's reception pregnancy has to be excluded or it is necessary to wait for the first periods.
Reception of the passed dragees
If delay in administration of drug made less than 12 hours, contraceptive protection does not decrease. The woman has to accept a dragee as soon as possible, the following is accepted in usual time.
If delay in reception of a dragee made more than 12 hours, contraceptive protection can be reduced. At the same time it is possible to be guided by the following two basic rules:
•    Administration of drug never has to be interrupted more, than for 7 days.
• 7 days of continuous reception of a dragee are required for achievement of adequate suppression гипоталамо - pituitary and ovarian regulation.
The following advice if delay in reception of a dragee made more than 12 hours (an interval can be respectively given from the moment of reception of the last dragee more than 36 hours):
• First week of administration of drug
The woman has to accept the last passed dragee as soon as possible as soon as remembers (even if it means reception of two dragees at the same time). The following dragee is accepted in usual time. The barrier method of contraception (for example, condom) during the next 7 days has to be in addition used. If the sexual intercourse took place within a week before the admission of a dragee, it is necessary to consider probability of approach of pregnancy. What more dragee is passed by, and than closer they to a break in reception of active agents, that a pregnancy high probability.
• Second week of administration of drug
The woman has to accept the last passed dragee as soon as possible as soon as remembers (even if for this purpose it is necessary to accept two dragees at the same time). The following dragee is accepted in usual time.
Provided that the woman accepted a dragee correctly within 7 days preceding the first passed dragee there is no need for use of additional contraceptive measures. Otherwise, and also at the admission of two and more dragees it is necessary to use in addition barrier methods of contraception (for example, condom) within 7 days.
• Third week of administration of drug
The risk of decrease in reliability is inevitable because of the forthcoming break in reception of a dragee.
The woman has to adhere strictly to one of two following options. At the same time if within 7 days preceding the first passed dragee all dragees were accepted correctly, there is no need to use additional contraceptive methods.
1. The woman has to accept the last passed dragee as soon as possible as soon as remembers (even if it means, reception of two dragees at the same time). The following dragee is accepted in usual time, dragees from the current packaging will not end yet. The following packaging should be begun at once. Bleeding of cancellation is improbable, the second packaging will not end yet, but the smearing allocations and breakthrough bleedings can be noted during reception of a dragee.
2. The woman can also interrupt reception of a dragee from the current packaging. Then it has to take a break for 7 days, including day of the admission of a dragee and then begin reception of new packaging.
If the woman missed reception of a dragee, and then during a break in reception of a dragee she has no cancellation bleeding, it is necessary to exclude pregnancy.
Recommendations in case of vomiting and diarrhea
If the woman had a vomiting or diarrhea in limits till 4 o'clock after reception of active dragees, absorption can be not full and additional contraceptive measures have to be taken. In these cases it is necessary to be guided by recommendations at the admission of a dragee.
Change of day of the beginning of a menstrual cycle
To delay the beginning of periods, the woman has to continue reception of a dragee from new packaging of Zhanin right after all dragees from previous, without interruption in reception are accepted. The dragee from this new packaging can be accepted as long as the woman wishes (until packaging does not end). Against the background of administration of drug from the second packaging at the woman the smearing allocations or breakthrough uterine bleedings can be noted. It is necessary to resume Zhanin's reception from a new pack after a usual 7-day break.
To transfer day began periods the next day of week, the woman should reduce the next break in reception of a dragee by so many days, on how many it wants. The interval is shorter, the risk is higher that it will have no cancellation bleeding, and further, there will be smearing allocations and breakthrough bleedings during reception of the second packaging (just as in case she like to delay the beginning of periods).

Additional information for special categories of patients
Children and teenagers
Jeanine's drug is shown only after approach of menarche. Patients of advanced age
It is not applicable. Jeanine's drug is not shown after approach of a menopause. Patients with disturbances from a liver
Jeanine's drug is contraindicated to women with a serious illness of a liver until indicators of function of a liver do not return to normal. See also section "Contraindications".
Patients with disturbances from kidneys
Jeanine's drug specially was not studied at patients with disturbances from kidneys. The available data do not assume change of treatment at such patients.

Features of use:

If any of the states, diseases and risk factors provided below are available now, then it is necessary to weigh carefully potential risk and the expected advantage of use of the combined oral contraceptives in each individual case and to discuss it with the woman before she decides to begin administration of drug. In case of weighting, strengthening or the first manifestation of any of these states, diseases or risk factors, the woman has to consult with the doctor who can make the decision on need of drug withdrawal.
•  Diseases of cardiovascular system
Results of epidemiological researches indicate existence of interrelation between use of the CPC and increase in frequency of development of venous and arterial thromboses and thromboembolisms (such as deep vein thrombosis, thromboembolism of a pulmonary artery, myocardial infarction, cerebrovascular disturbances) at reception of the combined oral contraceptives. These diseases are noted seldom.
The risk of development of a venous thromboembolism (VTE) is maximum in the first year of reception of such drugs. The increased risk is present after initial use of the combined oral contraceptives or resuming of use same or the different combined oral contraceptives (after a break between administrations of drug in 4 weeks and more). Data of a large prospective research with participation of 3 groups of patients show that this increased risk is present preferential within the first 3 months.
The general risk of a venous thromboembolism (VTE) at the patients accepting the low-dosed combined oral contraceptives (<50 mkg of ethinylestradiol) is two-three times higher, than at nonpregnant patients who do not accept the CPC, nevertheless, this risk remains lower in comparison with risk of VTE at pregnancy and childbirth.
VTE can lead to a lethal outcome (in 1-2% of cases).
The venous thromboembolism (VTE) which is shown as a deep vein thrombosis, or an embolism of a pulmonary artery can occur when using of any combined oral contraceptives.
Extremely seldom when using of the combined oral contraceptives there is thrombosis of other blood vessels, for example, of hepatic, mesenteric, renal, brain veins and arteries or vessels of a retina. A consensus concerning communication between emergence of these events and use of the combined oral contraceptives is absent.
Symptoms of the deep vein thrombosis (DVT) include the following: unilateral hypostasis of the lower extremity or along a vein on a leg, pain or discomfort in a leg only in vertical position or when walking, local temperature increase in the affected leg, reddening or change of coloring of integuments on a leg.
Symptoms of a thromboembolism of a pulmonary artery (TELA) consist in the following: the complicated or hurried breathing; sudden cough, including with a pneumorrhagia; an acute pain in a thorax which can amplify at a deep breath; feeling of alarm; severe dizziness; the speeded-up or irregular heartbeat. Some of these symptoms (for example, "short wind", "cough") are nonspecific and can be interpreted incorrectly as signs of other more or less heavy events (for example, respiratory infection).
The arterial thromboembolism can lead to a stroke, occlusion of vessels or a myocardial infarction. Symptoms of a stroke are as follows: sudden weakness or anesthesia of the person, hand or leg, especially on the one hand bodies, sudden confusion of consciousness, problem with the speech and understanding; sudden one - or bilateral loss of sight; sudden disturbance of gait, dizziness, loss of balance or coordination of movements; sudden, heavy or long headache for no apparent reason; a loss of consciousness or a syncope with an epileptic seizure or without it. Other signs of occlusion of vessels: sudden pain, puffiness and weak posineniye of extremities, acute abdomen.
Symptoms of a myocardial infarction include: pain, discomfort, pressure, weight, feeling of compression or a raspiraniye in a breast, in a hand or behind a breast; discomfort with irradiation in a back, a cheekbone, a throat, a hand, a stomach; cold sweat, nausea, vomiting or dizziness, strong weakness, alarm or asthma; the speeded-up or irregular heartbeat. The arterial thromboembolism can lead to a lethal outcome. The risk of development of thrombosis (venous and/or arterial) and thromboembolisms increases:
- with age;
- at smokers (with increase in quantity of cigarettes or increase in age the risk increases, especially at women 35 years are more senior);
in the presence:
- obesity (index of body weight of more than 30 kg/sq.m);
- the family anamnesis (for example, a venous or arterial thromboembolism ever at close relatives or parents at rather young age). In case of the hereditary or acquired predisposition, the woman has to be examined by the corresponding specialist for the solution of a question of a possibility of reception of the combined oral contraceptives;
- long immobilization, serious surgical intervention, any operation standing or extensive injury. In these situations it is desirable to stop use of the combined oral contraceptives (in case of the planned operation, at least, in four weeks prior to it) and not to resume reception within two weeks after the termination of an immobilization;
- dislipoproteinemiya;
- arterial hypertension;
- migraines;
- diseases of valves of heart;
- fibrillations of auricles.
The question of a possible role of a varicosity and superficial thrombophlebitis in development of a venous thromboembolism remains disputable.
It is necessary to consider the increased risk of development of thromboembolisms in a puerperal period.
Disturbances of peripheric circulation can be also noted at a diabetes mellitus, a system lupus erythematosus, a hemolitic uraemic syndrome, chronic inflammatory diseases of intestines (a disease Krone or nonspecific ulcer colitis) and a sickemia.
Increase in frequency and weight of migraine during use of the combined oral contraceptives (that can precede cerebrovascular disturbances) can be the basis for the immediate termination of reception of these drugs.
The following belongs to the biochemical indicators indicating the hereditary or acquired predisposition to venous or arterial thrombosis: resistance to the activated protein C, a gipergomotsisteinemiya, a lack of antithrombin-III, a lack of protein C, a lack of protein S, anti-phospholipidic antibodies (anti-cardiolipin antibodies, lupus anticoagulant).
At assessment of a ratio of risk and advantage, it is necessary to consider that adequate treatment of the corresponding state can reduce the related risk of thrombosis. Also it is necessary to consider that the risk of thromboses and thromboembolisms at pregnancy is higher, than at reception of the low-dosed oral contraceptives (<0,05 mg of ethinylestradiol).
• Tumors
The most essential risk factor of development of cancer of neck of uterus, the persistent human papillomavirus infection is. There are messages on some increase in risk of development of cancer of neck of uterus at prolonged use of the combined oral contraceptives. However, communication with reception of the combined oral contraceptives is not proved. Contradictions concerning in what degree these data are connected with screening regarding pathology of a neck of uterus or with features of a sexual behavior (more rare use of barrier methods of contraception) remain.
Meta-analysis of 54 epidemiological researches showed that there is a little increased relative risk of development of the breast cancer diagnosed for women who used the combined oral contraceptives (relative risk 1,24). The increased risk gradually disappears within 10 years after the termination of reception of these drugs. Because the breast cancer is noted seldom at women to 40 years, increase in number of diagnoses of a breast cancer at the women accepting the combined oral contraceptives now or accepting recently is insignificant in relation to the general risk of this disease. Its communication with reception of the combined oral contraceptives is not proved. Observed increase in risk can be also a consequence of earlier diagnosis of a breast cancer at the women applying the combined oral contraceptives. At the women ever using the combined oral contraceptives earlier stages of a breast cancer, than at women, never their applying come to light.
In rare instances against the background of use of the combined oral contraceptives development of tumors of a liver which in some cases led to life-threatening intra belly bleeding was observed. In a case emergence of severe pains in a stomach, increases in a liver or symptoms of intra belly bleeding it should be considered when carrying out the differential diagnosis.
•  Other states
At women with a gipertriglitseridemiya (or existence of this state in the family anamnesis) increase in risk of development of pancreatitis is possible during reception of the combined oral contraceptives.
Though small increase in arterial pressure was described at many women accepting the combined oral contraceptives, clinically significant increases were noted seldom. Nevertheless, if during reception of the combined oral contraceptives permanent, clinically significant increase in arterial pressure develops, it is necessary to cancel these drugs and to begin treatment of arterial hypertension. Reception of the combined oral contraceptives can be continued if by means of hypotensive therapy normal values of arterial pressure are reached.
The following states as it was reported, develop or worsen both during pregnancy, and at reception of the combined oral contraceptives, but their communication with reception of the combined oral contraceptives is not proved: jaundice and/or the itch connected with a cholestasia; formation of stones in a gall bladder; porphyria; system lupus erythematosus; hemolitic uraemic syndrome; Sydenham's chorea; herpes of pregnant women; the hearing loss connected with an otosclerosis. Disease cases Krone and nonspecific ulcer colitis against the background of use of the combined oral contraceptives are also described.
At women with hereditary forms of a Quincke's disease exogenous estrogen can cause or worsen symptoms of a Quincke's disease.
Acute or chronic abnormal liver functions can demand cancellation of the combined oral contraceptives until indicators of function of a liver do not return to norm. Recurrent cholestatic jaundice which develops for the first time in time of pregnancy or previous reception of sex hormones demands the termination of reception of the combined oral contraceptives.
Though the combined oral contraceptives can exert impact on resistance to insulin and tolerance to glucose, the patients with a diabetes mellitus using the low-dosed combined oral contraceptives have no need of change of the therapeutic mode (<0,05 mg of ethinylestradiol). Nevertheless, women with a diabetes mellitus have to be observed carefully during reception of the combined oral contraceptives.
The hloazma can sometimes develop, especially women with existence in the anamnesis have hloazma of pregnant women. Women with tendency to a hloazma during reception of the combined oral contraceptives have to avoid long stay to the sun and influences of ultraviolet radiation.
Preclinical data on safety
The preclinical data obtained during the standard researches regarding detection of toxicity at multiple dose of doses of drug, and also genotoxicity, cancerogenic potential and toxicity for reproductive system do not indicate existence of extra risk for the person. Nevertheless, it is necessary to remember that sexual steroids can promote growth of some hormonedependent fabrics and tumors.
Laboratory tests
Reception of the combined oral contraceptives can influence results of some laboratory tests, including indicators of function of a liver, kidneys, a thyroid gland, adrenal glands, level of transport proteins in plasma, indicators of carbohydrate metabolism, parameters of coagulation and a fibrinolysis. Changes usually do not overstep the bounds of normal values.
Decrease in efficiency
Efficiency of the combined peroral contraceptive drugs can be reduced in the following cases: at the admission of tablets, at vomiting and diarrheas or as a result of medicinal interaction.
Influence on a menstrual cycle
Against the background of reception of the combined oral contraceptives the irregular bleedings (smearing bloody allocations or breakthrough bleedings), especially within the first months of use can be noted. Therefore, assessment of any irregular bleedings has to be carried out only after the period of adaptation making about three cycles.
If irregular bleedings repeat or develop after the previous regular cycles, it is necessary to conduct careful examination for an exception of malignant new growths or pregnancy.
At some women during a break in reception of tablets cancellation bleeding can not develop. If the combined oral contraceptives were accepted as directed, it is improbable that the woman is pregnant. Nevertheless, if before the combined oral contraceptives were accepted irregularly or if there are no in a row two bleedings of cancellation, before continuation of administration of drug pregnancy has to be excluded.
Medical examinations
Before the beginning or resuming of use of drug of Jeanine it is necessary to study the anamnesis of life, the family anamnesis of the woman, to carry out careful all-medical (including measurement of the ABP, heart rate, definition of an index of body weight) and gynecologic inspection, including a research of mammary glands and a cytologic research of scraping from a neck of uterus (the test across Papanikolau), to exclude pregnancy. The volume of additional researches and frequency of control surveys is defined individually. Usually control examinations should be conducted at least 1 time a year.
It is necessary to warn the woman that Jeanine drugs do not protect from HIV infection (AIDS) and other diseases, sexually transmitted!

Influence on ability to drive the car and the equipment.
It is not revealed.

Side effects:

At reception of the combined oral contraceptives the irregular bleedings (smearing bloody allocations or breakthrough bleedings), especially within the first months of use can be noted.

Against the background of administration of drug of Jeanine at women also other undesirable effects provided in the table below were observed. Within each group allocated depending on the frequency of undesirable effect, undesirable effects are presented as weight reduction.

At the women receiving the CPC it was reported about development of the following undesirable effects (see also section "Special Instructions"):

· Venous tromboembolic episodes;

· Arterial tromboembolic episodes;

· Cerebrovascular complications;

· Hypertensia;

· Gipertriglitseridemiya;

· Change of tolerance in glucose or influence on insulin resistance of peripheral fabrics;

· Liver tumors (high-quality or malignant);

· Disturbances of functions of a liver;

· Hloazma;

· With a hereditary Quincke's disease exogenous estrogen can cause an aggravation of symptoms in women;

· Emergence or aggravation of states for which the interrelation with use of the CPC is definitively not proved: the jaundice and/or an itch connected with a cholestasia; formation of stones in a gall bladder; porphyria; system lupus erythematosus; gemolitiko-uraemic syndrome; Sydenham's chorea; herpes of pregnant women; an otosclerosis with deterioration in hearing, a disease Krone, ulcer colitis, cancer of a neck of uterus.

At the women using the CPC absolutely small increase in frequency of detection of a breast cancer is observed. As the breast cancer seldom arises at women up to 40 years, taking into account the general risk of development of a breast cancer, additional number of cases very little. The interrelation using the CPC is not known. Additional information is provided in the sections "Contraindications" and "Special Instructions".

Interaction with other medicines:

Interaction of oral contraceptives with other medicines can lead to breakthrough bleedings and/or decrease in contraceptive reliability. In literature it was reported about the following types of interaction.
Influence on hepatic metabolism: use of the drugs inducing microsomal enzymes of a liver can lead to increase of clearance of sex hormones. Treat such medicines: Phenytoinum, barbiturates, Primidonum, carbamazepine, rifampicin; also there are assumptions concerning an okskarbazepin, a topiramata, a felbamata, the griseofulvin and drugs containing a St. John's Wort.
HIV proteases (for example, ритонавир) and nenukleozidny inhibitors of the return transcriptase (for example, not Virapinum) and their combinations also potentially can influence hepatic metabolism.
Influence on enterohepatic circulation: according to separate researches, some antibiotics (for example, penicillin and tetracycline) can reduce kishechnopechenochny circulation of estrogen, thereby, lowering concentration of ethinylestradiol.
During any of above-mentioned medicines the woman should apply in addition a barrier method of contraception (for example, condom).
The substances influencing metabolism of the combined hormonal contraceptives (inhibitors of enzymes)
Диеногест is substrate of P450 (CYP) cytochrome 3A4. The known CYP3A4 inhibitors, such as azolovy antifungal drugs (for example, кетоконазол), Cimetidinum, verapamil, macroleads (for example, erythromycin), diltiazem, antidepressants and grapefruit juice, can increase plasma levels of a diyenogest.
During administration of drugs, influencing microsomal enzymes, and within 28 days after their cancellation it is necessary to use a barrier method of contraception in addition.
During reception of antibiotics (except for rifampicin and griseofulvin) and within 7 days after their cancellation it is necessary to use a barrier method of contraception in addition.   If   the period   of use  of a barrier   method  of protection comes to an end later, than tablets in packaging, it is necessary to pass to the following packaging of Zhanin without usual break in reception of a dragee.
The oral combined contraceptives can influence metabolism of other drugs that leads to increase (for example, cyclosporine) or to decrease (for example, ламотриджин) their concentration in plasma and fabrics.

Contraindications:

By Jeanine it should not be applied in the presence of any of the states/diseases which are listed below. If any of these states develop for the first time against the background of its reception, drug has to be immediately cancelled.
• Fibrinferments (venous and arterial) and thromboembolisms now or in the anamnesis (including, a deep vein thrombosis, a thromboembolism of a pulmonary artery, a myocardial infarction, a stroke), cerebrovascular disturbances.
• The states preceding thrombosis (including, the tranzitorny ischemic attacks, stenocardia) now or in the anamnesis.
• Migraine with focal neurologic symptoms now or in the anamnesis.
• A diabetes mellitus with vascular complications.
• The multiple or expressed risk factors of venous or arterial thrombosis, including the complicated defeats of the valve device of heart, fibrillation of auricles, diseases of vessels of a brain or coronary arteries of heart; uncontrollable arterial hypertension, serious surgical intervention with a long immobilization, smoking is aged more senior than 35 years.
• Pancreatitis with the expressed gipertriglitseridemiya now or in the anamnesis.
• A liver failure and a serious illness of a liver (before normalization of hepatic tests).
• Liver tumors (high-quality or malignant) now or in the anamnesis.
• The revealed hormonedependent malignant diseases (including generative organs or mammary glands) or suspicion of them.
• Bleeding from a vagina of not clear genesis.
• Pregnancy or suspicion on it.
• Feeding period breast.
• Hypersensitivity to any of components of drug of Jeanine.
With care
It is necessary to weigh carefully potential risk and the expected advantage of use of the combined oral contraceptives in each individual case in the presence of the following diseases / states and risk factors:
• Risk factors of development of thrombosis and thromboembolisms: smoking; obesity; dislipoproteinemiya, arterial hypertension; migraine; defects of valves of heart; long immobilization, serious surgical interventions, extensive injury; genetic predisposition to thrombosis (thromboses, a myocardial infarction or disturbance of cerebral circulation at young age at any of the immediate family)
• Other diseases at which disturbances of peripheric circulation can be noted: diabetes mellitus; system lupus erythematosus; hemolitic uraemic syndrome; disease Krone and nonspecific ulcer colitis; sickemia; phlebitis of superficial veins
• Hereditary Quincke's disease
• Gipertriglitseridemiya
• Liver diseases
• The diseases which for the first time arose or aggravated during pregnancy or against the background of the previous reception of sex hormones (for example, jaundice, a cholestasia, diseases of a gall bladder, an otosclerosis with deterioration in hearing, a porphyria, herpes of pregnant women, Sydenham's trochee)
• Puerperal period

Pregnancy and lactation
Jeanine is not appointed during pregnancy and during feeding by a breast.
If pregnancy comes to light during administration of drug of Jeanine, drug should be cancelled at once. However extensive epidemiological researches did not reveal the increased risk of defects of development in the children born by women, receiving sex hormones before pregnancy, or teratogenic action when sex hormones were accepted on imprudence in early durations of gestation.
Reception of the combined oral contraceptives can reduce amount of breast milk and change its structure therefore, their use is contraindicated at a lactation. A small amount of sexual steroids and/or their metabolites can be removed with milk.

Overdose:

About serious violations at overdose it was not reported. Symptoms which can be noted at overdose: nausea, vomiting, the smearing bloody allocations or a metrorrhagia. There is no specific antidote, it is necessary to carry out a symptomatic treatment.

Storage conditions:

To store at a temperature not above 25 °C. To store in the place, unavailable to children. Period of validity 3 years. Not to use after a period of validity!

Issue conditions:

According to the recipe

Packaging:

Dragee. On 21 dragees in the blister from a film of polyvinyl chloride and aluminum foil. 1 or 3 blisters together with the application instruction place in a cardboard pack.