Before starting the use of the drug, it is recommended to collect a detailed family and personal history and subsequently every 6 months. undergo general medical and gynecological examination (examination by a gynecologist, examination of a cytologic smear, examination of mammary glands and liver function, control of blood pressure (BP), cholesterol concentration in the blood, urine analysis). These studies need to be repeated periodically, due to the need for timely detection of risk factors or contraindications.
The drug is a reliable contraceptive drug: the Perl index (the indicator of the number of pregnancies that occurred during the application of the method of contraception in 100 women for 1 year) with proper application is about 0.05.Due to the fact that the contraceptive effect of the drug from the onset of admission is fully manifested by day 14, in the first 2 weeks of taking the drug, it is recommended additionally to use non-hormonal methods of contraception.
In each case, before the appointment of hormonal contraceptives individually evaluated the benefits or possible negative effects of their reception. This issue should be discussed with the patient, who after receiving the necessary information will make a final decision on the preferences of the hormonal or some other method. contraception. The state of women's health must be carefully monitored. If during the reception of the drug appears or worsens any of the below listed conditions / diseases, you must stop taking the drug and go to another, non-hormonal method of contraception:
-healthy hemostasis system.
-States / diseases, predisposing to the development of cardiovascular, renal failure.
-epilepsy
-migraine
risk of developing an estrogen-dependent tumor or estrogen-dependent gynecological diseases;
diabetes mellitus not complicated by vascular disorders;
- Severe depression (if depression is associated with a violation of tryptophan metabolism, then vitamin B6 can be used to correct it);
- sickle cell anemia, because in some cases (for example, infection, hypoxia), estrogen-containing drugs in this pathology can provoke thromboembolism.
-The appearance of abnormalities in laboratory tests assessing liver function.
Thromboembolic diseases
Epidemiological studies have shown that there is a link between the intake of oral hormonal contraceptives and an increased risk of arterial and venous thromboembolic diseases (including myocardial infarction, stroke, deep vein thrombosis of the lower limbs, pulmonary embolism). The increased risk of venous thromboembolic diseases has been proven, but it is significantly less than in pregnancy (60 cases per 100,000 pregnancies). When using oral contraceptives, arterial or venous thromboembolism of hepatic, mesenteric, renal vessels or retinal vessels is very rare.
The risk of arterial or venous thromboembolic disease increases:
-with age;
- When smoking (intensive smoking and age over 35 are among the risk factors);
-If there is a family history of thromboembolic diseases (eg, parents, brother or sister). If you suspect a genetic predisposition, you must consult a specialist before using the drug.
-if obesity (body mass index above 30 kg / m2);
- with dyslipoproteinemia;
- with arterial hypertension;
- in diseases of heart valves complicated by hemodynamic disorders,
-in atrial fibrillation;
-in diabetes, complicated by vascular lesions;
- with prolonged immobilization, after a large surgical intervention, after surgical intervention on the lower limbs, after severe trauma.
In these cases, a temporary discontinuation of the drug is expected: it is advisable to discontinue no later than 4 weeks before surgery, and resume - not earlier than 2 weeks after remobilization.
Increased risk of venous thromboembolic disease in women after childbirth.
Such diseases as diabetes, systemic lupus erythematosus,hemolytic-uremic syndrome, Crohn's disease, ulcerative colitis, sickle-cell anemia, increase the risk of venous thromboembolic disease.
Such biochemical abnormalities as resistance to activated protein C, hyperchromocysteinemia, protein deficiency C, S, antithrombin deficiency P1, the presence of antiphospholipid antibodies, increase the risk of arterial or venous thromboembolic disease.
When assessing the benefit / risk ratio of taking the drug, one should keep in mind that targeted treatment of this condition reduces the risk of thromboembolism. The signs of thromboembolism are:
- sudden pain in the chest, which radiates into the left arm,
- sudden shortness of breath,
an uncommonly strong headache that lasts for a long time or appears for the first time, especially when combined with sudden total or partial loss of vision or diplopia, aphasia, dizziness, collapse, focal epilepsy), weakness or severe numbness of the body, motor impairment, severe unilateral pain in the gastrocnemius muscle, with a sharp abdomen).
Tumor diseases
Some studies have reported an increase in the incidence of cervical cancer in women who have been taking hormonal contraceptives for a long time, but the results of research are contradictory. In the development of cervical cancer, sexual behavior, infection with human papillomavirus and other factors play a significant role. A meta-analysis of 54 epidemiological studies has shown that there is a relative increase in the risk of breast cancer among women taking oral hormonal contraceptives, but a higher detection of breast cancer could be associated with a more regular medical examination. Breast cancer is rare among women younger than 40, regardless of whether they take hormonal contraceptives or not, and increases with age. The intake of tablets can be regarded as one of many risk factors. Nevertheless, a woman should be informed of the possibility of a risk of developing breast cancer, based on an assessment of the relationship between benefit and risk (protection against ovarian cancer, endometrium and large intestine).
There are few reports of the development of a benign or malignant liver tumor in women who take long-term hormonal contraceptives. This should be borne in mind in the differential diagnosis of abdominal pain, which may be associated with an increase in liver size or intra-abdominal hemorrhage.
A woman should be warned that the drug does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
The effectiveness of the drug may decrease in the following cases:missed tablets, vomiting and diarrhea, simultaneous use of other drugs that reduce the effectiveness of birth control pills.
If the patient simultaneously takes another drug that may decrease the effectiveness of birth control pills, additional contraceptive methods should be used.
The effectiveness of the drug may decrease if after several months of their application irregular, spotting or breakthrough bleeding occurs, in such cases it is advisable to continue taking the tablets before their end in the next package.If at the end of the second cycle menstrual bleeding does not begin or acyclic spotting does not stop, stop taking the pills and resume it only after the pregnancy is excluded.
Chloasma
Chloasma can sometimes be found in women who have had a history in pregnancy. For women who are at risk of developing chloasma, avoid contact with sunlight or ultraviolet light while taking the tablets.
Changes in laboratory indicators
Under the influence of oral contraceptive pills - in connection with the estrogen component - the level of certain laboratory parameters (functional parameters of the liver, kidneys, adrenal glands, thyroid gland, hemostasis, levels of lipoproteins and transport proteins) can vary.
After acute viral hepatitis should be taken after the normalization of liver function (not earlier than 6 months). With diarrhea or intestinal disorders, vomiting contraceptive effect may decrease (without stopping the drug, it is necessary to use additional non-hormonal methods of contraception).Smoking women have an increased risk of developing vascular diseases with serious consequences (myocardial infarction, stroke). The risk depends on the age (especially in women older than 35 years) and on the number of cigarettes smoked. During lactation, milk production may decrease, in small amounts, the drug is excreted in breast milk.