If there are any diseases / conditions / risk factors listed below, the possible risk and expected benefits of using COCs in each individual case should be carefully weighed and discussed with the patient prior to taking Anabella. In the event of aggravation or the onset of any of these diseases / conditions / risk factors for the first time, a woman should consult a doctor who can decide whether 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 DVT, PE, myocardial infarction, cerebrovascular disorders). These diseases are rare.
The risk of VTE is maximal in the first year of taking COC. An increased risk is present after the initial use of the drugs or the resumption of use of the same or different COCs (after a break between doses of 4 weeks or more), mainly during the first 3 months.
The overall risk of VTE in patients taking low-dose COCs (<50 mcg ethinyl estradiol) 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. VTE can be life threatening or fatal (in 1-2% of cases).
According to some data, preparations containing drospirenone have a higher risk of developing thromboembolic complications, compared with drugs containing levonorgestrel, norgestimate or norethindrone.
VTE, manifested as DVT or PE, can occur when using any COCs.
It is extremely rare when using COC occurs thrombosis of other blood vessels, for example, liver, mesenteric, renal, cerebral veins and arteries or vessels of the retina. A common opinion regarding the relationship between the occurrence of these events and the use of COC is absent.
Symptoms of DVT include unilateral edema of the lower limb or along the vein, pain or discomfort in the limb only in the vertical position or walking, local temperature increase in the affected limb, redness or discoloration of the skin.
Symptoms of pulmonary embolism include difficulty breathing or rapid breathing, sudden coughing, including hemoptysis, acute pain in the chest, which can intensify with deep inhalation, 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 or less severe conditions (eg, respiratory tract infections).
Atherosclerosis may lead to stroke, vascular occlusion or myocardial infarction. Symptoms of a stroke include sudden weakness or loss of sensitivity of the face, upper and lower extremities, especially on one side of the body, sudden confusion, speech disorders or aphasia; sudden one- or two-sided vision loss, diplopia; sudden gait disturbance, dizziness, loss of balance or coordination of movements; sudden, severe or prolonged headache for no apparent reason; loss of consciousness or fainting with or without an epileptic seizure.
Other signs of vessel occlusion include sudden pain, puffiness and weak blueing of the extremities, and symptomatology of the "acute abdomen."
Symptoms of myocardial infarction include pain, discomfort, pressure, heaviness, a feeling of contraction or raspiraniya in the chest or behind the breastbone; pain with irradiation in the back, jaw, larynx, hand, stomach; cold sweats, nausea, vomiting or dizziness, severe weakness, anxiety, or shortness of breath; rapid or irregular heartbeat.
An ATE 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 total value of the available risk factors is increased. In this case, the drug Anabella® is contraindicated (see the section "Contraindications").
The risk of developing thrombosis (venous and / or arterial) and thromboembolism increases:
- with increasing age;
- among women who smoke (with an increase in the number of cigarettes or an increase in the age, the risk increases, especially in women over 35).
It increases with:
- Obesity (body mass index more than 30 kg / m2);
- dyslipoproteinemia;
- arterial hypertension;
- migraine;
- defeat of the heart valves;
- atrial fibrillation;
- family history (for example, venous or arterial thromboembolism ever at close relatives or parents at a relatively young age). In the case of a hereditary or acquired predisposition, a woman should be examined by an appropriate specialist to decide on the possible application of COCs;
- prolonged immobilization, serious surgical intervention, any operation on the lower extremities or extensive trauma. In these cases, the COC is discontinued (in the case of a planned operation, at least 4 weeks before it) and is not resumed for another 2 weeks after the recovery of the woman's full mobility.If necessary, barrier methods of contraception are recommended. Temporary immobilization (for example, air travel lasting more than 4 hours) may also be a risk factor for the development of VTE, especially if there are other risk factors.
The question of the possible role of varicose veins and superficial thrombophlebitis in the development of VTE remains controversial.
Violations of peripheral circulation can also occur in diabetes mellitus, systemic lupus erythematosus, 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) may be the reason for the immediate discontinuation of these medications.
Biochemical indicators indicating hereditary or acquired predisposition to venous or arterial thrombosis include the following: resistance to activated C-protein, hyperhomocysteinemia, antithrombin III deficiency, C-protein deficiency, deficiency S-protein, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant). When assessing the risk-benefit ratio, it should be borne in mind that adequate treatment of the relevant condition can reduce the risk of thrombosis associated with it. It should also be noted that the risk of thrombosis and thromboembolism in pregnancy is higher than when taking low-dose COCs (<50 mcg ethinyl estradiol).
Tumors
The most significant risk factor for developing cervical cancer is persistent papillomavirus infection. There are reports of a slight increase in the risk of developing cervical cancer with prolonged use of COCs. The connection with the reception of the COC has not been proved. Contradictions remain as to the extent to which these findings are associated with screening of cervical pathology or with features of sexual behavior (a more rare use of barrier methods of contraception).
There is also evidence of a reduction in the risk of endometrial and ovarian cancer when taking COCs. 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 who are currently taking COCs or who have recently taken COC is insignificant in relation to the overall risk of this disease. The observed increase in risk may be the result of an earlier diagnosis of breast cancer in women using these drugs, their biological effect or a combination of both. Women who use COC have earlier stages of breast cancer than women who have never used them.
In rare cases, with the use of COC, benign, and in very rare cases, malignant liver tumors, which in some cases led to life-threatening intraabdominal hemorrhage, was observed. This should be taken into account when making a differential diagnosis in the event of severe pain in the abdomen, liver enlargement, or signs of intra-abdominal bleeding. Tumors can endanger life or lead to death.
Other states
The results of clinical studies showed no effect of drospirenone on the potassium concentration in blood plasma in patients with mild and moderate renal insufficiency. There is a theoretical risk of developing hyperkalemia in patients with impaired renal function with an initial concentration of potassium in the blood plasma at the upper limit of the norm, simultaneously taking medications leading to a delay in potassium in the body. Nevertheless, in women with an increased risk of developing hyperkalemia, it is recommended to determine the concentration of potassium in the blood plasma during the first cycle of taking Anabella.
Women with hypertriglyceridemia (or having this condition in a family history) may have an increased risk of developing pancreatitis while taking Anabella. Although a small increase in blood pressure has been described in many women taking COC, clinically significant BP increases were rare. Nevertheless, if during the administration of the drug Anabella® a persistent, clinically significant increase in blood pressure develops, these drugs should be discontinued and treatment of arterial hypertension should begin.Reception of the drug Anabella® can be continued if normal blood pressure values are achieved with the help of antihypertensive therapy.
The following conditions occur or worsen during pregnancy and with COCs, but their relationship with the administration of these drugs has not been proven: jaundice and / or skin itching associated with cholestasis; formation of stones in the gallbladder; porphyria; systemic lupus erythematosus; hemolytic-uremic syndrome; chorea; herpes pregnant; 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.
Acute or chronic liver dysfunction may require the abolition of the drug Anabella® until the liver function test results return to normal. The recurrence of cholestatic jaundice, which developed for the first time during pregnancy or previous reception of sex hormones, requires the discontinuation of the Anabella® drug.
Although COCs can affect peripheral insulin resistance and glucose tolerance,dose adjustment and dosing regimen for hypoglycemic drugs in patients with diabetes using low-dose COCs (less than 50 μg ethinyl estradiol) is generally not required. Nevertheless, during the intake of Anabella®, women with diabetes should be closely monitored by the endocrinologist.
Sometimes chloasma can develop, especially in women with a history of pregnancy chloasma. Women predisposed to chloasma, while taking Anabella® should avoid prolonged exposure to sunlight and exposure to ultraviolet radiation.
Medical checkup
Before starting or resuming the use of Anabella, it is necessary to familiarize yourself with the history of life, the family history of the woman, to conduct a thorough medical examination (including measurement of blood pressure, heart rate, determination of BMI) and gynecological examination (including breast examination and cytological examination of the cervix epithelium) 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.
A woman should be warned that COCs do not protect against HIV infection (AIDS) and other sexually transmitted diseases. Also, tell the woman about the contraindications and precautions when using the drug Anabella.
Laboratory Tests
The administration of COC may affect the results of some laboratory tests, including liver, kidney, thyroid, adrenal, transport protein levels in the blood plasma (eg globulin binding corticosteroids, and lipid / lipoprotein fractions), carbohydrate metabolism, blood coagulation and fibrinolysis. Changes usually do not go beyond the limits of normal values. Drospirenone increases the activity of renin and aldosterone in the blood plasma, which is associated with its antimineralocorticoid effect.
Decreased efficiency
The effectiveness of the drug Anabella® can be reduced in the following cases: when you miss taking pills, vomiting, diarrhea, or as a result of drug interactions.
Insufficient control of the menstrual cycle
As with other COCs, irregular bleeding ("smearing" spotting or "breakthrough" bleeding) may occur with the drug Anabella®, especially in the first months of admission. Therefore, any irregular bleeding should be assessed only after an adaptation period of approximately three cycles.
If irregular bleeding recurs or develops after previous regular cycles, non-hormonal causes should be considered, as well as a thorough examination to exclude malignant neoplasms or pregnancy. The examination may include diagnostic scraping. During a break in taking active pills, some women may not have a bleeding "cancellation". If a woman has taken the drug Anabella® as directed, it is unlikely that she is pregnant. If a woman was taking the drug Anabella® irregularly or, in succession, there were no two bleeding "cancellations", pregnancy should be excluded before continuing with the drug.
Lactose
Tablets of the drug Anabella® contain lactose.Patients with rare hereditary lactose intolerance, lactase deficiency, glucose-galactose malabsorption should not take this drug.