Properties
What is it?
Drospirenone + Ethinylestradiol + Calcium Levomefolate Composition: Each orange film-coated tablet contains: Tablet core: Active substances: Ethinylestradiol (in the form of betadex clathrate) 0.030mg; Drospirenone 3.000mg; Calcium levomefolate 0.451mg; Excipients: Lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropylcellulose, magnesium stearate. Tablet coating: Hypromellose, macrogol 6000, talc, titanium dioxide (E 171), iron oxide, red (E 172), iron oxide, yellow (E 172). Each light orange film-coated tablet contains: Tablet core: Active substances: Calcium levomefolate 0.451mg; Excipients: Lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropylcellulose, magnesium stearate. Tablet coating: Hypromellose, macrogol 6000, talc, titanium dioxide (E 171), iron oxide, red (E 172), iron oxide, yellow (E 172). Indications: Contraception; Contraception and improvement of folate status. The decision to prescribe YARINA PLUS should be taken considering the woman's current individual risk factors, including those associated with the risk of developing venous thromboembolism (VTE). The risk of VTE development when taking YARINA PLUS should also be considered in relation to the risk of VTE development when taking other combined (oral) hormonal contraceptives (COCs). Contraindications: YARINA PLUS is contraindicated in women with the following diseases-pathologies. If any of them develops for the first time while taking the drug, its intake should be immediately discontinued. Risk of venous thromboembolism (VTE): Venous thromboembolism, current or in history (including deep vein thrombosis or pulmonary embolism); Hereditary or acquired predisposition to venous thrombosis, e.g., APC resistance (including Factor V Leiden), antithrombin III deficiency, protein C deficiency, protein S deficiency; Serious surgical intervention with prolonged immobilization; High risk of venous thromboembolism due to multiple risk factors; Risk of arterial thromboembolism (ATE): Arterial thromboembolism, current, or in history (e.g., myocardial infarction) or prodromal symptoms of thrombosis (e.g., angina pectoris); Cerebrovascular disorders-stroke, current or in history (including transient ischemic attacks); Hereditary or acquired predisposition to arterial thromboembolism, e.g., hyperhomocysteinemia and antiphospholipid antibodies (antibodies to cardiolipin, lupus anticoagulant); Migraine with focal neurological symptoms-current or in history; High risk of arterial thromboembolism due to multiple risk factors, e.g., diabetes mellitus; Severe arterial hypertension; Severe dyslipoproteinemia; Severe liver diseases-current or in history (until liver function tests normalize); Severe or acute renal failure; Concomitant use with direct-acting antiviral drugs that include ombitasvir, paritaprevir or dasabuvir and their combinations; Liver tumors (malignant or benign)-current or in history; Known or suspected hormone-dependent malignant diseases (including genital organs or mammary glands); Undiagnosed vaginal bleeding; Pregnancy and suspected pregnancy; Hypersensitivity to any of the components of YARINA PLUS. Pregnancy and lactation: Pregnancy: YARINA PLUS is contraindicated during pregnancy. Storage conditions: Store at a temperature not exceeding 25°C, out of reach of children. Dispensing rule: Pharmaceutical product group II, dispensed with prescription form N3.