Vidor film-coated tablets are indicated for oral contraception.
Composition
1 blister contains 28 tablets (21 active yellow tablets and 7 white placebo tablets).
Active ingredients: drospirenone, ethinylestradiol;
1 yellow film-coated tablet contains drospirenone 3.0 mg and ethinylestradiol 0.03 mg;
Excipients: lactose, corn starch, corn starch, crospovidonePlasdone XL-10 crospovidonePlasdone XL, povidone K-30, polysorbate 80, magnesium stearate, Opadry yellow (polyethylene glycol, polyvinyl alcohol, titanium dioxide (E 171), talc, iron oxide yellow (E172)).
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 oral contraceptives (COCs) should not be used in the presence of any of the conditions listed below. If any of the conditions listed below appear for the first time while taking COCs, the drug should be stopped immediately.
venous thrombosis (deep vein thrombosis, pulmonary embolism) present or history; arterial thrombosis (e.g. myocardial infarction) in history or presence of prodromal events (e.g. angina pectoris and transient ischemic attack); stroke in history.
Presence of severe or multiple risk factors for arterial thrombosis:
diabetes mellitus with vascular symptoms; severe arterial hypertension; severe dyslipoproteinemia; hereditary or acquired predisposition to venous or arterial thrombosis, including resistance to activated protein C (APC), antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant); history of pancreatitis, if associated with severe hypertriglyceridemia; history of severe liver disease until liver function tests return to normal; severe renal failure or acute renal failure; history of liver tumors (benign or malignant); known or suspected sex hormone-dependent tumors (e.g. tumors of the genital organs or mammary glands); vaginal bleeding of unclear etiology; migraine with focal neurological symptoms in history; hypersensitivity to any of the active substances or to any of the excipients; known or suspected pregnancy.
Method of application
Method of administration: oral administration.
When combined oral contraceptives (COCs) are used correctly, the failure rate is about 1% per year. If pills are missed or used incorrectly, the failure rate can increase.
The tablets should be taken at the same time every day, if necessary with a small amount of liquid, in accordance with the order indicated on the blister pack.
The tablets are taken continuously. One tablet is taken daily for 28 consecutive days. Taking the tablets from each subsequent pack begins the day after taking the last tablet from the previous pack.
Application features
Pregnant women
Contraindicated.
Children
The drug is indicated for use as prescribed by a doctor only after the onset of stable menstruation.
Drivers
No studies on the effects of the drug on the ability to drive and use machines have been conducted. No effect on the ability to drive and use machines has been observed in women using COCs.
Overdose
To date, there is no experience of overdose with drospirenone/ethinylestradiol. Based on general experience with combined oral contraceptives, symptoms that may occur with an overdose of active tablets are: nausea, vomiting, and in young girls - slight vaginal bleeding. There is no antidote and further treatment should be symptomatic.
Side effects
Emotional lability, headache, abdominal pain, acne, breast pain, breast enlargement, dysmenorrhea, metrorrhagia, weight gain.
Interaction
To determine possible interactions with drugs prescribed simultaneously with COCs, it is recommended to read the instructions for use of this drug.
The use of contraceptive steroids may affect the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and renal function, plasma levels of proteins (carriers), e.g. corticosteroid-binding globulins, and lipids/lipoprotein fractions, parameters of carbohydrate metabolism, and parameters of coagulation and fibrinolysis. In general, these changes remain within normal limits. Drospirenone causes an increase in plasma renin activity and plasma aldosterone levels through a slight antimineralocorticoid activity.
Storage conditions
Store out of the reach of children at a temperature not exceeding 25 °C.
Shelf life - 3 years.
