In the presence of any of the following conditions or risk factors, the benefits and possible harm of using KGC should be carefully weighed. This issue should be discussed with the patient even before taking the drug.
In case of aggravation of the disease, worsening of the condition or appearance of the first symptoms of the above conditions or risk factors, the patient should immediately consult a doctor. The doctor should decide whether to abolish KGC.
In this section, the term KGC is used when data are available for both oral and non-oral contraceptives: the term COC is used when data are available only for oral contraceptives.
Circulatory disorders
- In the course of epidemiological studies, a link was established between the use of CHC and the increased risk of arterial and venous thrombotic and thromboembolic disease, such as myocardial infarction, stroke, deep vein thrombosis and pulmonary embolism. These diseases are extremely rare.
- The use of any GGC is associated with an increased risk of developing VTE, manifested as deep vein thrombosis and / or pulmonary embolism. The greatest risk of VTE development is observed in the first year of application of KGC. The risk is also increased at the beginning of the use of KGC or with the resumption of the use of the same or another CGC after a break of 4 weeks or more.
- Some epidemiological studies show that women who took low-dose COCs containing a third generation of progestogens, including desogestrel, have an increased risk of developing VTE compared to those who took low-dose COCs containing levonorgestrel progestogen. These studies demonstrated an approximately twofold increase in the risk of developing VTE, which corresponds to 1-2 additional cases of VTE development per 10,000 LL. However, data from other studies did not show a twofold increase in the risk of developing VTE.
- The frequency of VTE development in patients taking low-dose KGC containing estrogen (<0.05 mg of ethinylestradiol) is from 3 to 12 cases per 10,000 LL. For comparison, a similar parameter in non-pregnant women who do not take KGC, is from 1 to 5 cases per 10,000 LL. The frequency of VTE development in the use of CHC is lower than the frequency of VTE development in pregnant women - from 5 to 20 cases per 10,000 women (pregnancy data are based on the actual length of pregnancy in standard studies, on the grounds that the pregnancy lasts 9 months, the risk is from 7 to 27 cases per 10,000 LL). VTE can lead to a lethal outcome in 1-2% of cases.In women in the postpartum period, the risk of VTE development ranges from 40 to 65 cases per 10,000 LL.
- Extremely rare in the use of CHC, thrombosis occurs in other blood vessels (for example, in veins and arteries of the liver, mesentery, kidney, brain or retina).
- Symptoms of venous and arterial thrombosis or acute impairment of the cerebral circulation may include the following conditions: sudden pain and / or edema of the lower limb, sudden intense chest pain irradiating or not radiating to the left arm, sudden shortness of breath, sudden cough, unusual severe and prolonged headache, sudden partial or complete loss of vision, diplopia, speech disorder or aphasia, dizziness, collapse accompanied or not accompanied by focal cramps, weakness or pronounced numbness, which suddenly appear on one side of the body, motor disorders, "acute abdomen."
- The risk of venous thromboembolism increases with the following risk factors:
- age;
- the presence of diseases in the family history (venous thrombosis and embolism in the brothers, sisters or parents at a young age).If hereditary predisposition is assumed, then before starting any hormonal contraceptives, you should consult a specialist;
- prolonged immobilization, extensive surgical intervention, any operation on the lower limbs or a serious injury. In these cases, it is recommended to stop taking COC (at least 4 weeks before the planned surgical intervention) and resume it only 2 weeks after the full recovery of the motor activity (see also the section "Contraindications");
- Obesity (body mass index more than 30 kg / m2);
- possibly, thrombophlebitis of superficial veins with varicose veins. There is no consensus on the possible role of these conditions in the etiology of venous thrombosis.
- The risk of complications of arterial thromboembolism increases with the following risk factors:
- age;
- smoking (the risk is even more likely to increase with intensive smoking, especially in women older than 35 years);
- dyslipoproteinemia;
- Obesity (body mass index more than 30 kg /m2).
- arterial hypertension;
- migraine;
- valvular heart disease;
- atrial fibrillation;
- the presence of diseases in the family history (arterial thrombosis in the brothers, sisters or parents at a young age). If hereditary predisposition is assumed, then before starting any hormonal contraceptives should consult with a specialist.
- It is necessary to take into account the increased risk of thromboembolism in the postpartum period (see the section on "Application during pregnancy and during breastfeeding").
- Other conditions that can lead to circulatory disorders include diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel diseases (eg, Crohn's disease or ulcerative colitis), and sickle cell anemia.
- An increase in the frequency or intensity of migraine (which may be a prodromal symptom of cerebral circulation disorders) during the application of COC may lead to an immediate cessation of COC use.
- Biochemical factors that may indicate hereditary or acquired predisposition to venous or arterial thrombosis include resistance to activated protein C, hyperhomocysteinemia, antithrombin deficiency III, Protein C Deficiency, Protein Deficiency S, Antiphospholipid antibody (antibodies to cardiolipin, lupus anticoagulant).
- In assessing the benefit / risk ratio doctor should take into account that these conditions therapy may reduce the associated risk of thrombosis.
Tumors
- The most important factor for cervical cancer risk is the persistence of human papillomavirus (HPV) infection. Some epidemiological studies have noted an increase in the risk of cervical cancer in women, long-term use of COCs, but to date there are inconsistencies regarding the degree of influence on the data blending of various factors, in particular the uptake of cervical screening, differences in sexual behavior including use of barrier methods of contraception , as well as the causal relationship of these factors.
- According to a meta-analysis of 54 epidemiological studies found a slight increase (1.24) the risk of developing breast cancer in women using COCs. The increased risk gradually decreases within 10 years after the cancellation of COC. Since breast cancer in women under 40 years of age is rare,the increase in the likelihood of developing breast cancer in women using COCs currently or recently abandoned their use is small relative to the initial likelihood of developing cancer. These studies do not provide data on the ethnology of cancer. The increased risk of developing breast cancer can be explained both by the fact that women taking COOK, The diagnosis of breast cancer is established at an earlier time, and biological effects COOK, or a combination of these factors. There is a trend according to which in women who have ever taken COC, breast cancer is clinically less neglected than in women who never took COOK.
- Very rarely in the use of COC, there have been cases of development of benign, and even more rarely, malignant liver tumors. In some cases, these tumors resulted in life-threatening intra-abdominal bleeding. The doctor should consider the possibility of having a liver tumor in the differential diagnosis of diseases in a woman taking COC, if the symptoms include acute pain in the upper abdomen, an enlarged liver, or signs of intra-abdominal bleeding.
Other states
- In women with hypertriglyceridemia or a corresponding family history, the risk of developing pancreatitis when taking COC is increased.
- Many women taking COC had a slight increase in blood pressure, but clinically significant increases in blood pressure were rare. The relationship between COC administration and hypertension is not established. However, if on the background of taking COC develops persistent arterial hypertension, it is advisable to cancel the COC and prescribe antihypertensive therapy. With adequate control of blood pressure with the help of antihypertensive drugs, it is possible to resume COC administration.
- Against the background of pregnancy and during application of COC, development or deterioration of the following conditions was noted, although their relationship with the reception of contraceptives is not definitively established; jaundice and / or itching caused by cholestasis, gallstones, porphyria, systemic lupus erythematosus, hemolytic uremic syndrome, Sydenham's chorea (small chorea), herpes of pregnant women, hearing loss due to otosclerosis, (hereditary) angioedema.
- Acute or chronic liver dysfunction can be the basis for cancellation of COCs until the liver function is normalized. The recurrence of cholestatic jaundice, observed earlier in pregnancy or with the use of sex hormones, requires the abolition of COCs.
- Despite the fact that COCs can render the effect on insulin resistance and glucose tolerance, the need for a change in the dosage regimen of hypoglycemic drugs in patients with diabetes mellitus taking COC containing less than 0.05 mg of ethinylestradiol is absent. In any case, it is necessary to carefully conduct periodic examinations of women with diabetes mellitus while taking COC.
- There is evidence that there is a link between the administration of COC and Crohn's disease and ulcerative colitis.
- Sometimes, when taking COC, pigmentation of the facial skin (chloasma) can occur, especially if it occurred earlier in pregnancy. Women with a predisposition to chloasma should avoid direct sunlight and ultraviolet radiation from other sources when taking COC.
- 1 tablet of Marvelon ® contains less than 80 mg of lactose.The drug is contraindicated in women with rare hereditary diseases associated with lactase deficiency, lactose intolerance, glucose-galactose malabsorption, on a lactose-free diet.
All the above information should be taken into account when choosing a method of contraception.
Medical examinations / consultations
Before the appointment or resumption of Marvelon® you should carefully review the medical history (including family) of a woman and exclude pregnancy. It is necessary to measure blood pressure and, in the presence of indications, conduct a physical examination taking into account contraindications and cautions. A woman should read the instructions for use and follow all recommendations. The frequency and nature of medical examinations depends on the individual characteristics of each patient, but medical examinations are conducted at least once every 6 months.The woman should be informed that oral contraceptives do not protect against HIV (AIDS) and other sexually transmitted infections.
Decreased efficiency
The effectiveness of COCs may be reduced if tablets are missed (see Table 1).(See the "Dosage and Administration" section), gastrointestinal disorders (see "Dosage and Administration") or in the case of concomitant therapy (see "Interaction with Other Drugs"Mr.th Ppreparations ").
Irregular spotting
When taking COC, especially in the first months of use, there may be irregular "smearing" or copious spotting, therefore an assessment of irregular bleeding should be made only after the end of the adaptation period lasting three months.
If irregular bleeding persists or appears after previous regular cycles, it is necessary to take into account possible non-hormonal causes of the cycle and conduct appropriate studies to exclude malignant neoplasms or pregnancy. These measures may include diagnostic scraping.
Some women may not have menstrual bleeding during a break between taking the drug. If the COC was taken according to the recommendations given above, the likelihood that the woman is pregnant is small. Otherwise, or if bleeding is absent two times in a row,Pregnancy should be excluded before continuing COC use.
Laboratory research
Oral contraceptives may affect the results of some laboratory tests, including biochemical parameters of liver, thyroid, adrenal and kidney functions, the content of transport proteins in the plasma, for example, corticosteroid-binding globulin (CSG) and lipid / lipoprotein fraction. parameters of carbohydrate metabolism, parameters of coagulation and fibrinolysis. Usually, these changes are within the normal values of laboratory indicators.