Smoking increases the risk of developing severe unwanted reactions from the cardiovascular system when using COCs. The risk rises with age and depends on the number of cigarettes smoked. The risk is more pronounced in women over the age of 35. Smoking women over the age of 35 should use other methods of contraception.
When applying the COC increases risk of serious diseases: myocardial infarction, thrombosis / thromboembolism, cerebrovascular disorders and neoplasms of the liver. Other risk factors, such as hypertension, hyperlipidemia, obesity and diabetes mellitus, clearly increase the risk of morbidity and mortality. In the presence of one of the above diseases / risk factors, it is necessary to weigh the possible benefits of the appointment of Angeletta against risks, and this should be discussed with the woman before she starts taking the drug.If these diseases or risk factors start to appear or progress during the administration of the drug, you should consult a doctor. The doctor must decide whether or not to take this medication.
Thromboembolism and other vascular diseases
It is noted that there is a correlation between the administration of COCs and an increased risk of diseases caused by venous or arterial thromboembolism, for example, myocardial infarction, cerebrovascular disorders, deep vein thrombosis or pulmonary embolism. These complications are rare.
In extremely rare cases when oral contraceptives were taken, thrombosis of vessels of rare localizations (liver, mesentery, kidneys, brain, retina) was reported. Taking COC leads to an increased risk of venous thromboembolism (VTE). The risk of VTE is greatest during the first year of admission. The degree of such risk is less than in pregnancy, when the frequency of VTE is 60 cases per 100,000 pregnancies. VTE leads to death in 1-2% of cases. There is no evidence of an evaluation of the risk of VTE when taking Angelote's medication compared to other COCs.
Risk of development venous thromboembolic complications when taking COC increases:
- with age;
- in the presence of thromboembolism in relatives (venous thromboembolism in siblings, sisters or parents at a relatively young age). If hereditary predisposition is presumed, it is recommended that a woman be referred to a specialist for advice before the Angeletta drug is prescribed;
- with prolonged immobilization;
- with obesity (body mass index> 30 kg / m2);
- with extended surgical interventions;
- at any operations on the lower extremities and pelvic region;
- with neurosurgical operations;
- with extensive injuries;
- with an air flight lasting more than 4 hours.
It is recommended to stop taking the preparation of Angeletta for the entire period of immobilization and for at least 2 weeks after restoring the patient's complete mobility.
Risk of development arterial thromboembolic complications when taking COC increases:
- with age;
- smokers;
- with dyslipoproteinemia;
- with obesity (body mass index> 30 kg / m2);
- with arterial hypertension;
- with heart diseases;
- with atrial fibrillation;
- in the presence of thromboembolism in relatives (arterial thromboembolism in siblings, sisters or parents at a relatively young age). If there is a presumed hereditary predisposition, it is recommended that a woman be referred for consultation to a specialist before the Angeletta drug is prescribed.
The risk of developing thromboembolic complications increases when there is a pronounced or a combination of several risk factors.
Other diseases affecting blood circulation are: diabetes mellitus, systemic lupus erythematosus, haemolytic uremic syndrome, chronic intestinal inflammations (Crohn's disease and ulcerative colitis), sickle cell anemia. When assessing the risk / benefit, it should be remembered that adequate treatment of the above diseases can reduce the risk of thrombosis. It is necessary to take into account the increased risk of thromboembolic complications in the postpartum period.
There is no consensus as to whether there is a relationship between venous thrombophlebitis and / or varicose veins and the etiology of venous thromboembolism. With the development of venous or arterial thrombosis, the following symptoms may occur:
- pain in lower limbs and / or swelling;
- sudden severe pain in the chest, with irradiation or without irradiation in the left arm;
- sudden shortness of breath, cough for no apparent reason;
- unexpected severe prolonged headache;
- partial or complete loss of vision;
- diplopia / speech disorders or aphasia;
- dizziness, collapse, in some cases accompanied by a focal epileptic seizure;
- sudden weakness or dysesthesia (perversion of sensitivity) on one side or in one part of the body;
- motor disorders;
- Sharp pain in the abdomen.
Women who are taking Angeletta should be informed that when symptoms appear that resemble thrombosis symptoms, you should consult your doctor. The preparation of Angeletta should be canceled if there is a suspicion or confirmation of a diagnosis of thrombosis.
The increase or increase in the severity of migraine attacks during the administration of Angellet's preparation (which may be a harbinger of development or a symptom of cerebrovascular disease) is an indication for the immediate discontinuation of Angellet's drug.
Tumors
It was noted that the use of COC is a risk factor for cervical cancer in women infected with human papillomavirus (HPV).However, the question of the degree of influence on the results of this observation of other concomitant factors (for example, the number of sexual partners or the use of mechanical contraceptives) remains controversial. There is evidence that the relative risk (RR= 1.24) of breast cancer in women who take COC is slightly higher. Within 10 years after stopping the COC, the risk level gradually decreases and returns to age. Because breast cancer is rare in women under the age of 40, the difference between the risk of breast cancer in current and recent COC women and the general risk of developing the disease is low.
There are reports of the development in rare cases of benign, even more rarely, malignant liver tumors during the administration of COCs. In some cases, these tumors are the causes of life-threatening intraabdominal bleeding. In case of severe pain in the abdomen, which does not go away by itself, hepatomegaly or signs of intra-abdominal bleeding, it is necessary to take into account the possibility of a liver tumor, and stop taking the drug Angellet.
Other diseases
Many women taking oral contraceptives have a slight increase in blood pressure; however, a clinically significant increase is rare. The relationship between the appointment of oral contraceptives and the clinical manifestation of hypertension has not been confirmed to date. If a clinically significant increase in blood pressure occurs during the reception of the Angellet drug, stop taking the medication and administer the treatment of hypertension. As soon as the blood pressure returns to normal against the background of antihypertensive therapy, the use of the drug Angeletta can continue.
In women with herpes of pregnant women in an anamnesis against the background of taking the drug Angellet can be a relapse of the disease. In women with hypertriglyceridemia in a history or a family history, the risk of developing pancreatitis increases with the use of the drug Angeletta. Acute or chronic liver dysfunction may require discontinuation of the drug before the liver function is normalized. The recurrence of cholestatic jaundice, which first arose during pregnancy or previous reception of sex hormones, requires the abolition of Angellet's preparation.
COCs may have an effect on insulin resistance or glucose tolerance. Therefore, patients with diabetes mellitus during the reception of the drug Angeletta should be under constant supervision.
In rare cases, chloasma may develop, especially in women with a history of pregnant women with chloasma. Women with a risk of developing chloasma should avoid exposure to sunlight and ultraviolet radiation while taking the drug Angeletta.
Patients with a rare congenital pathology - intolerance to galactose, deficiency of Lactate lactase or glucose-galactose malabsorption syndrome - use of the drug Angellet is contraindicated.
Medical examination
Before the appointment of the drug Angeletta, it is necessary to collect complete data on the health of the woman and her relatives in order to identify contraindications (see section Contraindications) and risk factors (see section Carefully). A woman must undergo a medical examination. The medical examination should be conducted every 6 months during the reception of the preparation of Angeletta. Regular medical examination is also necessary due to the fact that diseases that are contraindications (for example,transient ischemic attacks), or risk factors (for example, thrombosis of veins or arteries) may first appear against the background of taking the drug Angellet.
The medical examination should include measurement of blood pressure, examination of the mammary glands, abdominal and pelvic organs, including cytological examination of the cervical epithelium and appropriate laboratory tests.
A woman should be warned that the appointment of oral contraceptives, including that of Angeletta, does not protect her from becoming infected with HIV (AIDS) or other sexually transmitted diseases.
Insufficient efficiency
Passing the tablet (see section "Method of administration and dose "), vomiting and diarrhea, prolonged simultaneous use of certain medications (see section Interaction with other medicinal products) or, in very rare cases, metabolic disorders can reduce the effectiveness of contraception.
Effects on the menstrual cycle
"Breakthrough" bleeding or acyclic spotting
All oral contraceptives can cause irregular vaginal bleeding (bleeding "breakthrough" oracyclic spotting), especially during the first few cycles on the background of taking the drug. Therefore, a medical examination for irregular cycles should be conducted only after the adaptation period, which usually lasts for 3 cycles. If, during the reception of Angellet's preparation, the appearance of extraordinary bleeding continues or appeared for the first time in a woman with a regular cycle, a survey should be performed to exclude pregnancy or organic pathology. After the exclusion of pregnancy and organic pathology, the use of the drug Angeletta can continue or go to another drug.
Bleeding, appearing between cycles, may be a sign of insufficient contraceptive effectiveness.
Absence of menstrual bleeding (bleeding "withdrawal")
After 21 days after taking the drug, bleeding "cancellation" usually occurs. Sometimes, especially in the first few months of taking the drug, bleeding "cancellation" may be absent. However, this is not evidence of an insufficient contraceptive effect.If bleeding does not occur after taking the drug for one cycle, provided that no ingestion of the film-coated tablet was allowed, the period after completion of taking the drug did not exceed 7 days, no other medications were taken at the same time, there was no vomiting or diarrhea, pregnancy unlikely. After the exclusion of pregnancy and organic pathology, the use of the drug Angeletta can be continued. If you are taking the drug Angeletta instructions are not carried out before the first absence of bleeding, "cancel", or bleeding of "lifting" was absent for two consecutive cycles, pregnancy must be excluded for the presence of a decision on the continuation of treatment.
Simultaneously with the reception Angeletta drug should not be taken herbal medicines containing St. John's wort (Hypericum perforatum).
Laboratory indicators
During dosing Angeletta changes may occur some laboratory parameters, including functional activity of the liver, adrenal and thyroid-associated protein concentration in plasma (e.g., binding globulin sex hormones, lipoproteins), carbohydrate metabolism, coagulation and fibrinolysis.The nature and extent of changes are partly determined by the nature and dose of hormones taken.