In the presence of any of the following conditions or risk factors, the potentialrisk and the expected benefits of using the drug and discuss it with a woman before she decides to start taking the drug. In the event the existing symptoms of the disease, disease exacerbation, or the first signs of these states or the risk factors in the application of the drug, should consult with a physician who can decide whether to cancel the drug.
Thrombosis
Thrombosis is the formation of a blood clot (thrombus) that can clog the blood vessel. When thrombus is broken off, thromboembolism develops. Sometimes thrombosis develops in the deep veins of the lower extremities (deep venous thrombosis wei), vessels of the heart (myocardial infarction), brain (stroke), and rarely - in the vessels of other organs. The risk of deep vein thrombosis in women taking COC is higher than those who do not take them, but not as high as during pregnancy.
Epidemiological studies suggest an association between the use of COCs and an increased risk of thrombosis and thromboembolic diseases such as myocardial infarction, stroke, deep vein thrombosis and pulmonary embolism during COC.These complications are rare.
The risk of developing venous thromboembolism (VTE) is maximal in the first year of taking such drugs, mainly during the first 3 months. An increased risk is present after the initial use of COCs or with the resumption of the use of the same or different COCs (after a break between doses of 4 weeks or more). The overall risk of VTE in patients taking low-dose COCs (<50 mcg ethinylestradiol) is two to three times higher than in non-pregnant patients who do not take COC, however, this risk remains lower compared with the risk of VTE during pregnancy and childbirth .
In very rare cases, venous or arterial thromboembolism can be fatal. VTE, manifested as deep vein thrombosis and / or pulmonary embolism, can occur when using any COC. It is extremely rare when using COCs, thrombosis occurs in other blood vessels, for example, veins and arteries of the liver, mesentery, kidneys, brain or retina.
Symptoms of deep vein thrombosis (DVT) include the following: a one-sided swelling of the lower limb or along the vein on the lower limb,pain or discomfort in the lower extremity only in the vertical position or walking, local temperature increase in the affected lower limb, redness or discoloration of the skin on the lower limb.
Symptoms of thromboembolism of the pulmonary artery (PE) are as follows: shortness of breath or rapid breathing; sudden cough, incl. with 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 nonspecific and can be misinterpreted - as signs of other more common and less severe conditions / diseases (eg, respiratory tract infection).
In case of occurrence of the above listed symptoms in women taking COC, it is necessary to immediately consult a doctor.
The risk of VTE increases:
- with age;
- when smoking (with intensive smoking and with increasing age, the risk is further increased, especially in women over 35. Women over 35 should be strongly advised to quit if they want to take BONADE®);
- with a family history of family history (i.e.if there is an anamnesis of cases of venous thromboembolism at a relatively young age from parents or close relatives). In case of suspected hereditary predisposition, before deciding on any hormonal contraception the woman should consult with specialist;
- with prolonged immobilization, a serious surgical operation, any operation on the lower extremities or extensive trauma. In these situations, discontinue use planned operation not less than 4 weeks), and do not renew it until expiration of two weeks after full recovery motor activity. If application of BONADE preparation® not was terminated in advance, should consider the antithrombotic therapy;
- air travel of more than 4 hours;
- with obesity (body mass index more than 30 kg /m2).
The risk of arterial thromboembolic complications or disorders of the brain blood circulation is increased:
- with age;
- when smoking (with intensive smoking and with increasing age the risk is further increased, especially in women older than 35 years. Women older than 35 years should strongly recommend quit smoking if they want to take the drug BONADE®);
- with dyslipoprotenemine;
- with arterial hypertension;
- with migraine;
- with diseases of the valvular heart;
- with atrial fibrillation;
- with a family history (ie, with a history of arterial thrombosis cases in the relatively young age of the parents or close relatives). In case of suspected hereditary predisposition, before deciding on any hormonal contraception, a woman should consult a specialist.
Violations peripheral circulation also may occur in diabetes mellitus, systemic lupus erythematosus, hemolytic-uremic syndrome, chronic inflammatory bowel diseases (i.e. Crohn's disease or ulcerative colitis) and sickle cell anemia.
It is necessary to take into account the increased risk of thromboembolism in the postpartum period. Increasing the frequency or severity of migraine attacks during use BONADE® drug (which can be a precursor of cerebral circulation) is a cause for immediate withdrawal of the drug.
There is no consensus on the potential role of varicose veins and superficial thrombophlebitis in the development of VTE.
Tumors
The most important risk factor for cervical cancer is persistent papillomovirus infection. Some epidemiological studies show that long-term use of COCs can contribute to increasing this risk. However, there is still a discussion about how this result depends on other factors, such as cervical screening and more free sexual behavior and the rejection of barrier methods of contraception.
Meta-analysis the results 54 epidemiological studies suggest a slightly increased relative risk of breast cancer detection in women, applying COOK (relative risk 1.24). The increased risk gradually decreases within 10 years after stopping the COC administration. Given the fact that breast cancer is rare in women younger than 40 years, an increase in the number of diagnosed breast cancer in women taking or previously taking COCs is small compared to the overall risk breast cancer.These studies do not confirm the existence of a causal relationship. The cause of the observed increase in the incidence of breast cancer in women taking COCs may be earlier diagnosis, the biological effects of the drugs or a combination of these factors. Breast cancer diagnosed in women taking or previously taking COC. usually represents less clinically advanced cancer than in patients who never used them. Individual cases of benign liver tumors and, more rarely, malignant liver tumors in women taking COCs were diagnosed. In rare cases, such tumors caused life-threatening intraabdominal bleeding. In the case of severe pain in the upper abdomen, an increase in the liver, or signs of intra-abdominal bleeding in women taking COC, it is necessary immediately consult a doctor.
Other states
Among women, suffering hypertriglyceridemia or having this disease in a family history, the risk of pancreatitis during COC administration may be increased. Despite the fact that many women, receiving a COC, there was a slight increase in blood pressure, a clinically significant increase is rare. However, if a clinically significant increase in blood pressure develops (above 140/90 mm Hg) during the administration of COC, the BONADE® preparation should be discontinued and treatment of hypertension is started. The drug can be continued if normal blood pressure values are achieved with the help of antihypertensive therapy.
Cancellation of COCs may be unavoidable in acute and chronic violations of liver function until all the liver function indicators have returned to normal. Recurrences of cholestatic jaundice, which occurred for the first time during pregnancy or during the previous period of using COC, also require discontinuation of the drug. The use of COCs (which include the BONADE ® preparation) can cause the appearance or deterioration of conditions for which the association with the use of these drugs is not undeniable: jaundice and / or pruritus associated with cholestasis, gallstones, porphyria, systemic lupus erythematosus, hemolytic-uremic syndrome, Sydenham's chorea, herpes during an earlier pregnancy,hearing loss associated with otosclerosis.
Although COCs may have an impact on peripheral insulin resistance and glucose tolerance, women with diabetes mellitus who take low-dose COCs generally do not need a dose adjustment or dosage regimen for hypoglycemic drugs. Nevertheless, such women should be carefully monitored. Crohn's disease and ulcerative colitis can be associated with the administration of COCs. Sometimes there may be chloasma (hyperpigmentation of the facial skin), especially if it was observed during pregnancy. Women with a predisposition to chloasma during the use of COCs should beware of direct sunlight and exposure to other ultraviolet radiation. The disappearance of symptoms of acne (acne) usually occurs after 3-4 months of therapy.
Women should be warned that the drug BONADE® does not protect them from HIV infections and other sexually transmitted diseases.
Decreased efficiency
The effectiveness of COCs may decrease, for example, if skips are missed, in the case of gastrointestinal disorders (vomiting, diarrhea) or concomitant use other medications.
Irregularity of the cycle
During the administration of any COC, irregular bleeding may occur ("spotting" or "breakthrough" bleeding), especially in the first months of taking the pills. Bleeding usually ceases as the body adapts to BONADE® (usually after three cycles of taking tablets). If bleeding continues, and the degree of their severity increases, consult with an expert.
The absence of another bleeding "cancellation"
In some women, bleeding "cancellation" does not occur during a break in taking tablets. If the drug was taken in accordance with the instructions, the occurrence of pregnancy is unlikely. However, if the tablets were taken irregularly, or bleeding "cancellation" did not occur two times in a row, then before continuing the use of the drug, pregnancy should be excluded.
Laboratory research
The use of COCs can influence the results of laboratory tests, including biochemical indices of liver, thyroid, adrenal and kidney efficiency, the concentration of plasma proteins, for example, corticosteroid-binding globulin, lipid / lipoprotein composition of blood, carbohydrate metabolism and indicators of the blood coagulation system.However, deviations usually remain within the range of normal laboratory values.
Medical checkup
Before the first appointment or resumption of BONADE®, a detailed medical history should be collected and a medical examination performed taking into account contraindications, special instructions and precautions. The survey should be repeated on a regular basis. Regular medical examination is also necessary because of contraindications (for example, transient ischemic conditions, etc.) or risk factors (for example, the presence of venous or arterial thrombosis in a family history) that may occur for the first time only during the administration of COCs. The frequency and nature of such surveys should be based on approved practical techniques adapted to the particular patient, but in general they should include, first and foremost, pregnancy, blood pressure, including cytological examination of the epithelium of the cervix, exclude abnormalities on the part of the system blood coagulation.
In case of prolonged use preparation examination is necessary pass, at least 1 time in 6 months.
Consult your doctor as as soon as possible:
- With any changes health, especially any condition, listed in this application (see section "Contraindications" and "Carefully");
- For local compaction in the mammary gland;
- If you intend to apply other medications (see para. section "Interaction with other medicinal products ");
- If a prolonged immobilization (for example, on the foot is imposed gypsum), hospitalization is planned or surgery (consult a doctor for 4-6 weeks before it);
- In case of unusual occurrence severe uterine bleeding;
- If you forgot to take the pill in the first week of receiving the package (blister) and there was sexual contact one week before this;
If you have not had another "bleeding" bleeding twice or you suspect that you are pregnant (do not start taking the next package (blister) until you consult a doctor).