If any of states, diseases or risk factors indicated below are currently available, the potential risk and expected benefits of using COCs, including Microginone®,in each individual case and discuss it with a woman before she decides to start taking the drug. In case of weighting, strengthening or the first manifestation of any of these conditions or risk factors, a woman should consult her doctor to decide whether to stop taking the drug.
- Diseases of the cardiovascular system
Epidemiological studies indicate a relationship between the use of COCs and increased incidence of venous and arterial thrombosis and thromboembolism (such as deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders). These diseases are rare.
The risk of developing venous thromboembolism (VTE) is maximal in the first year of taking such drugs. The increased risk is present after the initial use of COC or the resumption of the use of the same or different COCs (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 patients receiving low-dose COC (containing less than 0.05 mg ethinyl estradiol) two to three times higher than in non-pregnant patients who are not taking COCs, nevertheless, this risk is lower than the risk of VTE at pregnancy and childbirth.
VTE can be life threatening or lead to death (in 1-2% of cases).
VTE, manifested in the form of 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 (DVT): unilateral edema or lower extremity along the vein in a lower limb, pain or discomfort in the lower limb in a vertical position or during walking, the local increase in temperature, redness or discoloration of the skin in the affected lower limb.
Symptoms of thromboembolism of the pulmonary artery (PE): shortness of breath or rapid breathing; sudden cough, including hemoptysis; acute pain in the chest,which can intensify with a deep inspiration; sense of anxiety; severe dizziness; rapid or irregular heartbeat. Some of these symptoms (eg, dyspnea, cough) are nonspecific and may be misinterpreted as signs of other more or less severe complications (eg, respiratory tract infection).
Arterial thromboembolism can lead to stroke, vascular occlusion or myocardial infarction. Symptoms of a stroke: sudden weakness or loss sensitivity in 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 squeezing or squashing in the chest or behind the breastbone, with irradiation in the back,jaw, upper limb, 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, taking the drug Microginon® is contraindicated (see the section "Contraindications").
The risk of developing thrombosis (venous and / or arterial) and thromboembolism or cerebrovascular disorders is increased:
- with age;
- for smokers (with an 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 a family history (for example, venous or arterial thromboembolism ever at close relatives or parents at a relatively young age). In case of a hereditary or acquired predisposition, a woman should be examined by the appropriate specialist to decide on the possibility of taking COC;
- with obesity (body mass index more than 30 kg / m2);
- with dyslipoproteinemia;
- with arterial hypertension;
- with migraine;
- with diseases of the heart valves;
- with atrial fibrillation;
- in case of prolonged immobilization, serious surgical intervention, any operation on the lower limbs or extensive trauma. In these situations, it is recommended that COCs be discontinued (in the case of a planned operation, at least four weeks before) and do not resume admission within two weeks after the end of 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.
The question of the possible role of varicose veins and superficial thrombophlebitis in the development of VTE remains controversial.
You should consider the increased risk of thromboembolism in the postpartum period.
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 (which may precede cerebrovascular disorders) during the use of COCs may be grounds for the immediate cessation of these medications.
Biochemical indicators indicating an inherited or acquired predisposition to the development of venous or arterial thrombosis include:
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 relationship between risk and benefit, 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 noted that the risk of thrombosis and thromboembolism in pregnancy is higher than when taking low-dose COCs (containing less than 0.05 mg of ethinylestradiol).
- 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. Communication with the reception of the COC is not proved.There are still contradictions as to the extent to which these data are associated with screening for the pathology of the cervix or with the characteristics of sexual behavior (the 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 COC (relative risk 1.24). Increased risk gradually disappears within 10 years after discontinuation of these drugs. Due to the fact that breast cancer is rare in women under 40 years of age, the increase in the incidence 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 the result of an earlier diagnosis of breast cancer in women using COCs (they have earlier clinical forms of breast cancer diagnosed than women who did not use COCs), the biological effect of COCs, or a combination of both.
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 event of severe pain in the abdomen, liver enlargement, or signs of intra-abdominal bleeding, this should be taken into account when making a differential diagnosis.
- Other states
In women with hypertriglyceridemia (or the presence of this condition in a family history) during the administration of COCs, an increased risk of developing pancreatitis may occur.
Despite the fact that a slight increase in blood pressure was described in many women taking COC, a clinically significant increase was noted rarely. 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 COCs 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 connection with the administration of COC is not proved: cholestatic jaundice and / or itching 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. Cases of Crohn's disease and ulcerative colitis are also described against the background of COC use.
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 have an effect on insulin resistance and glucose tolerance, there is usually no need to correct the dose of hypoglycemic drugs in diabetic patients using low-dose COCs (containing less than 0.05 mg of ethinyl estradiol).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 while taking COC should avoid prolonged exposure to the sun and exposure to ultraviolet radiation.
Laboratory Tests
The use of drugs such as Microinon ® may affect the results of some laboratory tests, including biochemical parameters of liver, thyroid, kidney and adrenal function, the concentration of transport proteins in the plasma (eg globulin, corticosteroids, lipid / lipoprotein fractions, parameters of carbohydrate metabolism , coagulation and fibrinolysis). These changes, as a rule, remain within the limits of normal physiological values.
Decreased efficiency
The effectiveness of COCs can be reduced in the following cases: with the omission of tablets, gastrointestinal disorders or as a result of drug interactions.
Effect on the character of bleeding
With the use of COC, irregular bleeding (spotting spotting and / or breakthrough 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.
Some women during the break in taking pills may not develop a bleeding "cancellation". If Microginone® was taken as directed, it is unlikely that a woman is pregnant. However, if before this preparation Microgynon ® was taken irregularly, or if there are no consecutive two bleeding "cancellations", before continuing with the drug should be excluded pregnancy.
Medical examinations
Prior to the initiation or resumption of the use of the Microgynon® preparation, you need to familiarize yourself with the history of life, the family history of the woman, conduct a general medical examination (including measuring blood pressure, determining the body mass index), and gynecological examination (including breast examination and cytological study of the epithelium of the cervix), to exclude pregnancy.The frequency and nature of such surveys should be based on existing standards of medical practice, with the necessary consideration of the individual characteristics of each patient (but at least every 6 months).
It must be remembered that the preparation Microginon ® does not protect against HIV infection (AIDS) and other sexually transmitted diseases!
Conditions requiring medical advice
- Any changes in health, especially the occurrence of conditions listed in the sections "Contraindications" and "Use with caution";
- Local compaction in the mammary gland;
- Simultaneous reception of other medications (see also "Interaction with other drugs");
- If prolonged immobilization is expected (for example, gypsum is applied to the lower limb), hospitalization or surgery is planned (at least four weeks before the proposed operation);
- Unusually violent bleeding from the vagina;
- A tablet was missed in the first week of taking the drug 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 pills from the next package before consulting a doctor).
You should stop taking the pills and immediately consult a doctor 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.