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 aggravation, intensification, or with the first manifestation of risk factors, it may be necessary to cancel the drug.
Diseases of the cardiovascular system
There is evidence of an increased incidence of venous and arterial thrombosis and thromboembolism (such as deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders) with COCs. These diseases are rare.
Before starting the use of Femiss® Gynsta®, you should discuss with a woman a higher (almost 2-fold) risk of developing venous thromboembolism (VTE) compared to other COCs containing levonorgestrel, norgestimate or norethisterone. This risk is highest in the first year of taking the drug or with the resumption of its use after a break for 4 weeks or more.
Data from a large prospective study with 3 groups of women show that this increased risk is present mainly during the first 3 months.
The overall risk of VTE in women taking low-dose COCs (<50 mcg ethinylestradiol) is 2-3 times higher than in women who do not take COC and are not pregnant, and it remains lower in comparison with the risk of VTE during pregnancy and childbirth.
In 1-2% of cases, VTE leads to a lethal outcome.
VTE, manifested as deep vein thrombosis and / or pulmonary embolism, can occur with any COCs.
Very rarely, when using COC, thrombosis occurs in other blood vessels, for example, liver, mesenteric, renal, cerebral veins and arteries or retinal vessels.
Symptoms of deep vein thrombosis include: edema of the lower limb or along the vein on the lower extremity, pain or discomfort in the lower limb only in the vertical position or walking, sensation of warmth in the lower extremity, reddening or discoloration of the skin of the lower limb.
Symptoms of pulmonary embolism include: difficulty breathing or rapid breathing; a sudden cough, including hemoptysis; acute pain in the chest, which can intensify with a deep inspiration; sense of anxiety; severe dizziness; rapid or irregular heartbeat.
Arterial thromboembolism can lead to stroke, vascular occlusion or a heart attack myocardium. Symptoms of a stroke: sudden weakness or loss of face sensitivity, extremities, especially on the one hand: a sudden confusion of consciousness; disorientation and dysarthria; sudden full or partial loss of vision; sudden gait disturbance: dizziness; loss of coordination of movements; sudden severe or prolonged headache for no apparent reason; loss of consciousness or fainting, accompanied by a seizure or without seizures. Other signs of vascular occlusion: sudden pain, puffiness and weak blueing of the extremities, "acute abdomen."
Symptoms of myocardial infarction: pain, discomfort, pressure, feeling of heaviness, contraction or raspiraniya in the chest, in the hand or behind the breastbone; discomfort with irradiation in the back, cheekbone, larynx, hand, stomach; cold sweat; nausea, vomiting; dizziness; strong weakness; sense of anxiety; dyspnea; rapid or irregular heartbeat.
Arterial thromboembolism can be life threatening or fatal.
Women with a combination of several risk factors or high severity of one of them should consider the possibility of their mutual reinforcement.In such cases, the degree of risk increase may be higher than with a simple summation of factors. In this case, taking Femiss® Gynesta® is contraindicated (see section "Contraindications").
The risk of developing thrombosis (venous and / or arterial) and thromboembolism increases:
- with age;
- smokers (with an increase in the number of cigarettes or an increase in age, the risk further increases, especially in women over 35 years of age);
- if there is a family history (ie venous or arterial thromboembolism in close relatives or parents at a relatively young age). In the case of hereditary predisposition, a woman should be examined by the appropriate specialist to decide on the possibility of taking COC;
- with obesity (body mass index more than 30 kg / m2);
- in the case of prolonged immobilization, serious surgical interventions, any operation on the lower limbs or extensive trauma. In these situations, the drug should be discontinued (in the case of a planned operation, at least four weeks before it) and do not resume admission within two weeks after the end of immobilization.Temporary immobilization (for example, air travel lasting more than 4 hours) may also be a risk factor for VTE. especially if there are other risk factors;
- with dyslipoproteinemia;
- with arterial hypertension:
- with migraine;
- with diseases of the valvular heart;
- with atrial fibrillation.
The question of the possible role of varicose veins and superficial thrombophlebitis in the development of VTE remains controversial.
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.
Increased frequency and severity of migraine during COC use (which can precede cerebrovascular disorders) may be the basis for the immediate discontinuation of these medications.
Biochemical indicators indicating 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 antibodies (antibodies to cardiolipin, lupus anticoagulant).
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 has been some increase in the risk of cervical cancer with prolonged use of COCs. However, the connection with the reception of the COC has not been proven. There are contradictions as to the extent to which these data are associated with cervical pathology or with peculiarities of sexual behavior (a more rare application 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 rarely seen in women under 40 years of age, an increase in the number of diagnoses of breast cancer in women,taking COCs now or recently, is insignificant 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. This should be taken into account when making a differential diagnosis in the event of severe pain in the abdominal region, increased liver, or signs of intra-abdominal bleeding.
Other states
In women with hypertriglyceridemia (or in 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, a clinically significant increase in blood pressure was noted rarely. Nevertheless, if a persistent, clinically significant increase in blood pressure develops during the administration of COC, these drugs should be discontinued and the treatment of hypertension should begin. Reception of COCs can be continued if normal blood pressure values are achieved with the help of antihypertensive therapy. Women with an arterial hypertension in the anamnesis or diseases which are associated Arterial hypertension (including renal dysfunction) should use other methods of contraception. If women with hypertension make a choice in taking COC, then they need careful medical supervision. In the case of a significant increase in blood pressure, COCs should be discontinued.
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. Cases of Crohn's disease and ulcerative colitis are also described against the background of COC use.
In women with hereditary forms of angioedema, exogenous estrogens can cause or worsen symptoms of angioedema.
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.
In acute or chronic violations of the liver, it may be necessary to cancel the drug until the liver function indicators return to normal. The recurrence of cholestatic jaundice, which developed for the first time in pregnancy or previous reception of sex hormones, requires discontinuation of COCs.
Although COCs may have an effect on insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in diabetic patients using low-dose COCs (<50 μg ethinylestradiol).Nevertheless, women with diabetes require careful monitoring of blood glucose concentrations during the use of the drug.
Against the background of taking Femiss® Gynsta®, there may be a worsening of the course of endogenous depression and epilepsy.
Medical examinations
Before starting or resuming the use of Femiss® Gynsta®, you need to familiarize yourself with the history of life, the family history of the woman, and carry out a thorough medical examination (including measuring blood pressure, heart rate, body mass index) and gynecological examination, including mammary gland and cytology with the cervix (a test for Pap test), exclude pregnancy. In addition, violations of the blood coagulation system should be avoided. 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.
A woman should be informed that the preparation Femiss® Ginesta® does not protect against HIV infection (acquired immunodeficiency syndrome - AIDS) and other sexually transmitted diseases.
Decreased efficiency
The efficacy of Femiss® Gynsta® may decrease if the drug is not taken, gastrointestinal disorders (see the section "Method of administration and dose") or as a result of drug interaction (see section "Interaction with other medicinal products").
Effect on the nature of bleeding
Against the background of the use of COC, irregular (acyclic) bleeding (spotting spotting and / or breakthrough bleeding) can occur, especially during first months of use. Therefore, any irregular bleeding should be assessed only after an adaptation period of approximately 3 cycles.
If irregular bleeding recurs or develops after previous regular cycles, a thorough examination should be conducted to exclude malignant neoplasms or pregnancy.
Some women during the break in taking pills may not develop a bleeding "cancellation". If the COC was administered in accordance with the directions, pregnancy is unlikely. However, if prior to this, the COC was not taken regularly, or if there are no consecutive "bleeding" bleedings,then before continuing with the drug should be excluded from pregnancy.
Impact on laboratory test scores
Acceptance of COC can influence the results of some laboratory tests, including indicators of liver function, kidney function, thyroid gland, adrenal gland, transport protein concentration in blood plasma, lipid fraction, carbohydrate metabolism, coagulation and fibrinolysis parameters. Changes usually remain within normal physiological values.