Vidora micro tablets are indicated for oral contraception.
Composition
Active ingredients: drospirenone, ethinylestradiol;
1 blister contains 28 tablets (21 active pink tablets and 7 white placebo tablets);
1 pink film-coated tablet contains drospirenone 3.0 mg and ethinyl estradiol 0.02 mg;
Excipients: lactose, corn starch, povidone K-30, croscarmellose sodium, polysorbate 80, magnesium stearate, Opadry® II pink (polyethylene glycol, polyvinyl alcohol, titanium dioxide (E 171), talc, iron oxide yellow (E 172), iron oxide red (E 172), iron oxide black (E 172)).
1 white film-coated tablet (placebo) contains:
Excipients: lactose, povidone K-30, magnesium stearate, Opadry® II white (polyvinyl alcohol (hydrolyzed part), titanium dioxide (E 171), macrogol 3350, talc (E 553b)).
Contraindication
Combined hormonal contraceptives (CHCs) should not be used if any of the following conditions are present. If any of these conditions appear for the first time during CHC use, the drug should be stopped immediately.
Presence or risk of venous thromboembolism (VTE): Current VTE, particularly due to anticoagulant therapy or a history (e.g. deep vein thrombosis (DVT) or pulmonary embolism (PE)); Known hereditary or acquired predisposition for VTE, such as resistance to activated protein C (including factor V Leiden mutation), antithrombin-III deficiency, protein C deficiency, protein S deficiency; Major surgery with prolonged immobilization; High risk of VTE due to the presence of multiple risk factors. Presence or risk of arterial thromboembolism (ATE): Current or history of ATE (e.g. myocardial infarction) or presence of prodromal symptoms (e.g. angina); Current or history of cerebrovascular accident, presence of prodromal symptoms (e.g. transient ischemic attack (TIA)); Known hereditary or acquired predisposition to ATO, such as hyperhomocysteinemia and antibodies to phospholipids (anti-cardiolipin antibodies, lupus anticoagulant); History of migraine with focal neurological symptoms; High risk of ATO due to the presence of multiple risk factors or due to the presence of one serious risk factor, such as: diabetes mellitus with vascular complications; Severe arterial hypertension; Severe dyslipoproteinemia. Current or history of severe liver disease until liver function tests have returned to normal. Severe renal failure or acute renal failure. Current or history of liver tumors (benign or malignant). Known or suspected malignant tumors (e.g., genital or breast) dependent on sex hormones. Vaginal bleeding of unclear etiology. Hypersensitivity to the active substances or to any of the components of the drug.
The drug Vidora micro is contraindicated when used concomitantly with drugs containing ombitasvir / paritaprevir / ritonavir and dasabuvir.
Method of application
The tablets should be taken daily in the order indicated on the package, at about the same time, washed down with a small amount of liquid if necessary. The tablets should be taken continuously. The drug should be taken 1 tablet / day for 28 consecutive days. Taking the tablets from each subsequent package should begin the day after the end of the previous package. Usually, withdrawal bleeding begins on the 2nd-3rd day after starting the placebo tablets (the last row) and may not end before starting the tablets from the next package.
Application features
Pregnant women
The drug is contraindicated for use during pregnancy.
Children
The drug is indicated for use as prescribed by a doctor only after the onset of stable menstruation.
Drivers
No studies have been conducted on the effect of Vidora Micro on the reaction rate when driving or operating other mechanisms.
Overdose
There are no clinical data on overdose of Vidora micro tablets. Based on general experience with COCs, overdose may cause nausea, vomiting, and in young girls, vaginal bleeding. Vaginal bleeding may occur in girls even before menarche in case of unintentional/accidental use of the drug. There is no specific antidote; treatment should be symptomatic.
Side effects
Women taking CHCs have been shown to be at increased risk of developing venous or arterial thrombotic and thromboembolic events, including myocardial infarction, stroke, TIA, venous thrombosis and PE.
Interaction
The use of contraceptive steroids may affect the results of some laboratory tests, such as biochemical parameters of liver, thyroid, adrenal and renal function, the plasma concentration of transport proteins such as corticosteroid-binding globulin, the plasma concentration of lipid/lipoprotein fractions, and parameters of carbohydrate metabolism, coagulation and fibrinolysis. These changes are usually within normal limits. Drospirenone increases plasma renin and aldosterone activity, which is induced by its moderate antimineralocorticoid activity.
Store out of the reach of children at a temperature not exceeding 25 °C.
Shelf life - 3 years.
