If any of the conditions, diseases or risk factors outlined below are present, carefully weigh the potential risk and the expected benefits of using the drug Jeanine® in each individual case and discuss it with the woman before she decides to start taking preparation. In the case of weighting, amplification or the first manifestation of any of these states,diseases or risk factors, a woman should consult with her doctor who can decide whether to cancel the drug.
- Diseases of the cardiovascular system
There are epidemiological data on the increase in the incidence of venous and arterial thrombosis and thromboembolism (such as deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke) with COCs. These diseases are rare.
The risk of developing venous thromboembolism (VTE) is maximal in the first year of taking such drugs. An increased risk is present after the initial use of COC or the resumption of the use of the same or another COC (after a break between doses of 4 weeks or more). Data from a large prospective study with 3 groups of patients show that this increased risk is present mainly during the first 3 months.
The overall risk of VTE in women taking low-dose COCs (<0.05 mg of ethinyl estradiol) is two to three times higher than in non-pregnant patients who do not take COC, however, this risk remains lower compared to the risk of VTE during pregnancy and childbirth.
VTE can be life threatening or lead to death (in 1-2% of cases).
VTE, manifested as deep vein thrombosis or pulmonary embolism may occur when using any COCs.
Very rarely, when using COC, thrombosis occurs in other blood vessels, for example, liver, mesenteric, renal, cerebral veins and arteries or retinal vessels.
Symptoms of deep vein thrombosis: unilateral swelling of the lower extremity or edema along the veins on the lower limb, pain or discomfort in the lower limb, and only in the vertical position or walking, local temperature increase in the affected lower limb, reddening or discoloration of the skin of the lower extremity.
Symptoms of thromboembolism of the pulmonary artery: difficulty or rapid breathing; sudden cough, including hemoptysis; acute pain in the chest, which can increase with a deep breath; sense of anxiety; severe dizziness; rapid or irregular heartbeat. Some of these symptoms (eg, dyspnea, cough) are non-specific and may be misinterpreted as signs of other more common and less severe conditions / diseases (eg, respiratory tract infections).
Arterial thromboembolism can lead to stroke, vascular occlusion or myocardial infarction. Symptoms of a stroke include: sudden weakness or loss of sensitivity of the face, limbs, especially on one side of the body, sudden confusion, problems with speech and understanding; sudden one- or two-sided loss of vision; sudden gait disturbance, dizziness, loss of balance or coordination of movements; sudden, severe or prolonged headache for no apparent reason; loss of consciousness or fainting with or without an epileptic seizure. Other signs of vascular occlusion: sudden pain, puffiness and weak blueing of the extremities, "sharp" abdomen.
Symptoms of myocardial infarction: pain, discomfort, pressure, heaviness, a feeling of contraction or raspiraniya in the chest or behind the breastbone, with irradiation in the back, jaw, left upper extremity, epigastric region; cold sweats, nausea, vomiting or dizziness, severe weakness, anxiety, or shortness of breath; rapid or irregular heartbeat. Arterial thromboembolism can be life threatening or fatal.
Women with a combination of several risk factors or high severity of one of them should consider the possibility of their mutual reinforcement. In such cases, the degree of risk increase may be higher than with a simple summation of factors. In this case, the use of the drug Jeanin® is contraindicated (see section "Contraindications").
The risk of developing thrombosis (venous and / or arterial) and thromboembolism or cerebrovascular disorders is increased:
- with age;
- smokers (with the increase in the number of cigarettes or an increase in the age of the risk increases, especially in women older than 35 years);
in the presence of:
- obesity (body mass index more than 30 kg / m2);
- family history (for example, venous or arterial thromboembolism ever at close relatives or parents at a relatively young age). In the case of a hereditary or acquired predisposition, a woman should be examined by the appropriate specialist to decide on the possibility of taking Zanin®;
- prolonged immobilization, extensive surgical intervention, any operation on the lower extremities or extensive trauma.In these cases, the preparation of the drug Jeanine® should be discontinued (in the case of a planned operation, at least four weeks before) and do not resume the reception for two weeks after immobilization. Temporary immobilization (for example, air travel lasting more than 4 hours) may also be a risk factor for venous thromboembolism, especially if there are other risk factors;
- dyslipoproteinemia;
- arterial hypertension;
- migraine;
- heart valve diseases;
- atrial fibrillation.
The question of the possible role of varicose veins and superficial thrombophlebitis in the development of V'GE remains controversial.
An increased risk of thromboembolism in the postpartum period should be considered.
Violations of peripheral circulation can also occur in diabetes mellitus, systemic lupus erythematosus, hemolytic-uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell anemia.
An increase in the frequency and severity of migraine during the use of the preparation of Jeanine® (which may precede cerebrovascular disorders) is the basis for the immediate withdrawal of this drug.
Biochemical indicators indicating hereditary or acquired predisposition to venous or arterial thrombosis include the following: resistance to activated protein C, hyperhomocysteinemia, and deficiency of antithrombin III. Protein C deficiency, protein deficiency S. antiphospholipid antibodies (antibodies to cardiolipin, lupus anticoagulant).
When assessing the risk-benefit ratio, it should be borne in mind that adequate treatment of the relevant condition can reduce the risk of thrombosis associated with it. It should also be taken into account that the risk of thrombosis and thromboembolism in pregnancy is higher than when taking low-dose COCs (<0.05 mg of ethinyl estradiol).
- Tumors
The most significant risk factor for developing cervical cancer is persistent papillomavirus infection. There are reports of a slight increase in the risk of developing cervical cancer with prolonged use of COCs. However, the connection with the reception of the COC has not been proven. Contradictions remain regarding the extent to which these data are associated with screening for cervical pathology or with features of sexual behavior (a more rare use of barrier methods of contraception).
A meta-analysis of 54 epidemiological studies showed that there is a slightly increased relative risk of developing breast cancer diagnosed in women currently taking COCs (relative risk 1.24). Increased risk gradually disappears within 10 years after discontinuation of these drugs. Due to the fact that breast cancer is rarely seen in women under 40 years of age, an increase in the number of diagnoses of breast cancer in women who are currently taking COCs or who have recently taken COC is insignificant in relation to the overall risk of this disease. His connection with the use of COC has not been proven. The observed increase in risk may also be a consequence of an earlier diagnosis of breast cancer in women using COCs. Women who have ever used COC. earlier stages of breast cancer are revealed than in women who never used them.
In rare cases, the development of benign, and extremely rare, malignant liver tumors, which in some cases led to life-threatening intraabdominal hemorrhage, was observed with the use of COCs.In the case of severe pain in the abdominal region, enlarged liver, or signs of intra-abdominal bleeding, this should be taken into account when making a differential diagnosis.
- Other conditions
In women with hypertriglyceridemia (or the presence of this condition in a family history), an increased risk of developing pancreatitis during COC administration is possible.
Despite the fact that a small increase in blood pressure was described in many women taking COC, clinically significant increases were rarely noted. However, if a persistent clinically significant increase in blood pressure develops during the administration of COCs, these drugs should be discontinued and treatment of hypertension should begin. Reception of the drug can be continued if normal blood pressure values are achieved with the help of antihypertensive therapy.
The following conditions have been reported to develop or worsen, both during pregnancy and when taking COC, but their relationship with COCs has not been proven: jaundice and / or pruritus associated with cholestasis; formation of stones in the gallbladder; porphyria; systemic lupus erythematosus; hemolytic-uremic syndrome; chorea; herpes during pregnancy; hearing loss associated with otosclerosis.Also, cases of worsening of the course of endogenous depression, epilepsy, Crohn's disease and ulcerative colitis are described along with the use of COCs.
In women with hereditary forms of angioedema, exogenous estrogens can cause or worsen symptoms of angioedema.
Acute or chronic liver dysfunction may require cancellation of the COC until the liver function returns to normal. Recurrence of cholestatic jaundice, which developed for the first time during previous pregnancy or previous reception of sex hormones, requires discontinuation of COCs.
Although COCs may affect insulin resistance and glucose tolerance, the need for dose adjustment for hypoglycemic agents in patients with diabetes mellitus using low-dose COCs (<0.05 mg ethinylestradiol) generally does not occur. Nevertheless, women with diabetes should be carefully monitored while taking COC.
Sometimes chloasma can develop, especially in women with a history of pregnancy chloasma. Women with a tendency to chloasma during the use of the drug Jeanine® should avoid prolonged exposure to the sun and exposure to ultraviolet radiation.
Preclinical dacha for safety
Preclinical data obtained from routine studies to detect toxicity with multiple doses of the drug, as well as genotoxicity, carcinogenic potential, and toxicity to the reproductive system, do not indicate a particular risk to humans. Nevertheless, it should be remembered that sex hormones can promote the growth of certain hormone-dependent tissues and tumors.
Laboratory Tests
The administration of the preparation ZHanin® can influence the results of some laboratory tests, including liver, kidney, thyroid, adrenal, traffic protein in plasma, carbohydrate metabolism parameters, blood coagulation parameters and fibrinolysis. Changes usually do not go beyond the limits of normal values.
Decreased efficiency
The effectiveness of the drug Jeanine ® can be reduced in the following cases: when skipping dragees, gastrointestinal disorders or as a result of drug interactions.
Frequency and severity of menstrual bleeding
Against the background of taking Zanin®, irregular bleeding ("spotting" bleeding and / or "breakthrough" uterine bleeding) can occur, especially during the first months of use.Therefore, any irregular bleeding should be assessed only after an adaptation period of approximately three cycles.
If irregular bleeding recurs or develops after previous regular cycles, a thorough examination should be conducted to exclude malignant neoplasms or pregnancy.
The absence of another menstrual bleeding
Some women may not develop a bleeding "withdrawal" during a break in taking a dragee. If the preparation Zhanin® was taken according to recommendations, it is unlikely that a woman is pregnant. Nevertheless, if the drug has not been used regularly or if there are no consecutive "bleeding" bleedings, the drug can not be taken until the pregnancy is excluded.
Medical examinations
Before starting or resuming the use of JAnin®, you need to familiarize yourself with the history of life, the family history of a woman, and conduct a thorough medical examination (including measuring blood pressure, heart rate, body mass index) and gynecological examination,including breast examination and cervical cytology (Papanicolaou test), to exclude pregnancy. With the resumption of JAnin®, the amount of additional research and the frequency of follow-up visits is determined individually, but not less than once every 6 months.
It must be borne in mind that the preparation of Janine® does not protect against HIV infection (AIDS) and other sexually transmitted diseases!
Conditions requiring medical advice
- Any changes in health, especially the emergence of conditions listed in the sections "Contraindications" and "With caution";
- Local compaction in the mammary gland;
- Simultaneous reception of other medications (see also "Interaction with other drugs");
- If prolonged immobility is expected (for example, gypsum is applied to the lower extremity), hospitalization or surgery is planned (at least four weeks before the proposed operation);
- Unusually violent bleeding from the vagina;
- The pills were missed in the first week of taking the package and there was sexual contact seven or less days before;
- The absence of another menstrual bleeding twice or a suspicion of pregnancy (do not start taking the pills from the next package before consulting a doctor).
You should stop taking the pills and consult your doctor immediately if there are possible signs of thrombosis, myocardial infarction or stroke: an unusual cough; unusually severe pain behind the sternum, giving to the left arm; unexpected shortness of breath, unusual, severe and prolonged headache or migraine attack; partial or complete loss of vision or double vision; inarticulate speech; sudden changes in hearing, smell, or taste; dizziness or fainting; weakness or loss of sensitivity in any part of the body; severe pain in the abdomen; severe pain in the lower limb, or a sudden edema of any of the lower limbs.