Sofitel tablets are used for oral contraception.
Composition
Active ingredients: ethinylestradiol, dienogest;
1 film-coated tablet (white) contains ethinylestradiol 0.03 mg, dienogest 2 mg;
Excipients: lactose, corn starch, K-30, vegetable magnesium stearate, coating: hypromellose 2910, polyethylene glycol, titanium dioxide (E 171).
1 tablet, coated with a placebo shell (green) contains: lactose, corn starch, K-30, colloidal silicon, magnesium stearate, shell: hypromellose 2910, triacetin (E1518), polysorbate, titanium dioxide (E171), FD&C Blue 2 Aluminum Lake (E132), iron oxide yellow (E172).
Contraindication
Combined hormonal contraceptives (CHCs) should not be used if any of the conditions listed below are present. If any of these conditions appear for the first time during use, they should be discontinued immediately.
Presence or risk of venous thromboembolism (VTE):
current (while on anticoagulant therapy) or history of venous thromboembolism (e.g. deep vein thrombosis (DVT) or pulmonary embolism (PE)); known hereditary or acquired predisposition to venous thromboembolism, 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 venous thromboembolism due to the presence of multiple risk factors.
Presence or risk of arterial thromboembolism (ATE):
arterial thromboembolism - the presence of arterial thromboembolism now or in history (for example, myocardial infarction) or the presence of prodromal symptoms (for example, angina); current or history of cerebrovascular accident, the presence of prodromal symptoms (for example, transient ischemic attack (TIA)); known hereditary or acquired predisposition to arterial thromboembolism, such as hyperhomocysteinemia and antibodies to phospholipids (anticardiolipin antibodies, lupus anticoagulant); migraine with focal neurological symptoms in history; high risk of arterial thromboembolism 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; pancreatitis now or in history, if associated with severe hypertriglyceridemia. Severe liver disease, present or in history, until liver function tests have returned to normal. Current or history of liver tumors (benign or malignant). Known or suspected malignant tumors (e.g., genital or breast) that are sex hormone dependent. Known or suspected pregnancy. Vaginal bleeding of unknown etiology. Known or suspected pregnancy. Hypersensitivity to the active substances or to any of the excipients.
The drug Sofitel is contraindicated when used simultaneously with drugs containing ombitasvir / paritaprevir / ritonavir and dasabuvir.
Method of application
Sofita® tablets are intended for oral use.
Application features
Pregnant women
Contraindicated.
Children
The drug is indicated for use only after the onset of menstruation.
Drivers
No studies on the effects on the ability to drive or use machines have been conducted. No effects on the ability to drive or use machines have been observed in women using COCs.
Overdose
The acute toxicity of ethinylestradiol and dienogest when administered orally is very low. If, for example, a child takes several tablets of the drug Sofitel at the same time, it is unlikely that symptoms of intoxication will occur. Symptoms that may occur in this case include nausea, vomiting and withdrawal bleeding. Withdrawal bleeding may occur in girls even before menarche in case of unintentional / accidental use of the drug. Specific treatment is usually not required. If necessary, symptomatic therapy can be carried out.
Side effects
From the nervous system: often (from ≥ 1/100 to ≤ 1/10) - headache.
Reproductive system and breast disorders: common (≥ 1/100 to ≤ 1/10) - breast tenderness.
Interaction
The use of contraceptive steroids may affect the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and renal function, plasma concentrations of proteins (carriers) such as GSK, lipid/lipoprotein fractions, parameters of carbohydrate metabolism, and indicators of coagulation and fibrinolysis. Usually such changes are within normal limits.
Storage conditions
Store at a temperature not exceeding 30 °C.
Keep out of reach of children.
Shelf life - 3 years.
