If any of the conditions, diseases and risk factors identified below are present, careful consideration should be given to the potential risk and expected benefit of using COCs in each individual case and to discuss it with the woman before she decides to start taking the drug. With weighting, strengthening, or with the first manifestation of risk factors, it may be necessary to cancel the drug.
Diseases of the cardiovascular system
The results of epidemiological studies indicate the existence of a relationship between the use of COCs and an increase in the incidence of venous and arterial thrombosis and thromboembolism, such as deep vein thrombosis.thromboembolism of the pulmonary artery, myocardial infarction, cerebrovascular disease. The risk of venous thromboembolism (VTE) is especially high during the first year of COC use. The approximate frequency of VTE in women taking oral low-dose oral contraceptives (less than 50 μg ethinyl estradiol) is from 20 cases per 100,000 reproductive years of women (for preparations containing levonorgestrel) to 40 cases per 100,000 reproductive years of women (for preparations containing desogestrel / gestoden) compared to 5-10 cases per 100,000 reproductive years for women who do not take COC and 60 cases per 100,000 pregnancies. VTE leads to a lethal outcome in 1-2% of cases.
Women taking COCs have extremely rare cases of thrombosis of other blood vessels, for example, liver, mesenteric, renal arteries and veins or veins and arteries of the retina. The relationship of these cases with the use of COCs has not been proven.
A woman should stop taking the drug and consult a doctor if symptoms of venous or arterial thrombosis develop, which may include unilateral pain in the lower limb and / orswelling: sudden severe chest pain with irradiation or without in the left arm; sudden shortness of breath; sudden coughing attacks; any unusual, strong, prolonged headache: increased frequency and severity of migraine; sudden partial or complete loss of vision; Diplomacy; slurred speech or aphasia; dizziness; fainting with or without a seizure attack; weakness or very significant loss of sensitivity, suddenly appeared on one side or in one part of the body; motor disorders; "sharp" abdomen.
the risk of thrombosis (venous and / or arterial) and thromboembolic events increases with age, in smokers (with increasing number of cigarettes smoked, or increasing age the risk further increases, especially in women over 35 years), in the presence of family history (ie venous or arterial thromboembolism ever in close relatives or parents at a relatively young age), obesity (body mass index over 30 kg / m2) Dislipoproteinemia, hypertension, disease of the heart valves, prolonged immobilization, major surgery, any surgery to the legs, or major trauma, atrial fibrillation.
The question of the possible role of varicose veins and superficial thrombophlebitis in the development of venous thromboembolism remains controversial. In the case of a planned operation, the drug should be discontinued at least 4 weeks before and should not be resumed within 2 weeks after the end of immobilization. An increased risk of thromboembolism in the postpartum period should be considered.
Violations of peripheral circulation can also occur in diabetes mellitus, SLE, 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 attacks during the use of COCs (which may precede cerebrovascular disorders) should be grounds for the immediate discontinuation of these medications.
The presence of a single expressed risk factor or multiple risk factors is a contraindication to the use of an oral contraceptive. The possibility of anticoagulant therapy should be considered. You should choose a suitable alternative method of contraception.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.
Tumors
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). The most significant risk factor for developing cervical cancer is persistent papillomavirus infection. 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). The increased risk gradually disappears within 10 years after discontinuation of these medications. Due to the fact that breast cancer is rare in women under 40 years old. an increase in the number of diagnoses of breast cancer in women who are currently taking COCs or who have recently taken is small in relation to the overall risk of this disease.The relationship between the development of breast cancer and the use of COC has not been proven. The observed increase in risk may be due not only to an earlier diagnosis of breast cancer in women using COC, but also to the biological effect of sex hormones or a combination of these two factors. Women who have ever used COC have earlier stages of breast cancer than women who have 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 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), 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 hypertension was rare.Nevertheless, if a persistent, clinically significant increase in blood pressure develops during the administration of COC, the drug 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 relationship with COC use has not been proven: jaundice and / or pruritus associated with cholestasis; formation of stones in the gallbladder: porphyria; SLE; hemolytic-uremic syndrome; chorea; herpes during pregnancy; hearing loss associated with otosclerosis.
There have been reports of worsening of the course of endogenous depression, epilepsy, Crohn's disease and ulcerative colitis during COC administration.
In women with hereditary forms of angioedema, exogenous estrogens can cause or worsen symptoms of angioedema.
In acute or chronic violations of liver function, it may be necessary to cancel the drug before normalizing the parameters of functional liver samples.Recurrent cholestatic jaundice, which develops for the first time during pregnancy or previous admission of sex hormones, requires discontinuation of COCs.
Although COCs can affect insulin resistance and glucose tolerance, as a rule, correction of the dosage regimen for hypoglycemic drugs in patients with diabetes mellitus is not required. Nevertheless, women with diabetes require careful monitoring of blood glucose concentrations during the use of the drug.
When using the drug, the development of chloasma is possible, especially in women with a history of pregnant chloasma. Women with a tendency to chloasma while taking COC should avoid prolonged exposure to the sun and exposure to ultraviolet radiation.
Decreased efficiency
The effectiveness of COCs can be reduced by skipping tablets, vomiting and diarrhea, or as a result of drug interactions with concomitant medications.
Medical examinations
Before starting or resuming the use of MODELL® LIBER, it is necessary to familiarize yourself with the history of life, the family history of a woman, to conduct a thorough general medical (including measuring blood pressure,heart rate, body mass index), and gynecological examinations, including breast examination and cytological examination of scrapings from cervical (Pap test), to exclude pregnancy. The volume of additional studies and the frequency of follow-up visits are determined individually. Usually, follow-up examinations should be conducted at least once every 6 months.
The woman must be informed that the drug MODELL® Lieber does not protect against HIV infection (Acquired Immunodeficiency Syndrome - AIDS) and other diseases, sexually transmitted diseases.
Influence on the menstrual cycle
On the background of the use of COC, irregular (acyclic) bleeding (spotting spotting or breakthrough bleeding) can occur, especially during the first 3 months of use. Therefore, any irregular bleeding should be assessed only after an adaptation period of approximately 3 cycles.
In clinical studies, the drug MODELL® Liberia scheduled menstrualnopodobnoe bleeding (bleeding "cancel") and / or the appearance of "smearing" bleeding remained relatively constant, lasted an average of three days during each cycle lasting 91 days.The frequency of unplanned bleeding "cancellation" and unplanned "smearing" bloody discharge was reduced during a cycle of 91 days. A woman should be warned that in the case of "spotting" bleeding or the occurrence of unplanned bleeding, you should still adhere to the same regimen for taking MODELL® LIBER. If the bleeding is permanent or lasts too long, a woman should consult a doctor.
If a woman did not have a bleeding "cancellation" during the 13th week (when taking white tablets containing ethinyl estradiol), the possibility of pregnancy should be excluded.
Impact on laboratory test scores
Admission COC can affect the results of some laboratory tests, including indicators of liver function, kidney function, thyroid gland, adrenal gland, plasma protein concentration, carbohydrate metabolism, coagulation and fibrinolysis parameters. Changes usually do not go beyond the limits of normal values.
Conditions requiring medical advice
- Any changes in the state of 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 immobilization is expected (for example, gypsum is applied to the lower limb), hospitalization or surgery is planned (at least 4-6 weeks before the proposed operation);
- Uncommonly severe bleeding from the vagina;
- A tablet was 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 pills from the next package before consulting a doctor).
The woman should stop taking the pills and immediately consult a doctor if there are possible signs of thrombosis, myocardial infarction or stroke (see section "Special instructions").