Simvastatin Sandoz film-coated tablets 40 mg blister No. 30

Simvastatin Sandoz tablets are indicated for the treatment of hypercholesterolemia and for cardiovascular prevention.

Composition

Active ingredient: simvastatin;

1 film-coated tablet contains 10 mg or 20 mg of simvastatin;

Excipients: lactose, microcrystalline cellulose, corn starch, butyloxyanisole (guaiacol), ascorbic acid, citric acid, silicon dioxide, talc, magnesium stearate, red iron oxide, yellow iron oxide, triethyl citrate, titanium dioxide, povidone.

Contraindication

Method of application

Daily doses of the drug - from 5 mg (use the dosage form with the appropriate dosage) to 80 mg orally 1 time per day in the evening. Dose selection should be carried out at intervals of at least 4 weeks to a maximum daily dose of 80 mg, taken once a day in the evening. The dose of 80 mg is recommended only for patients with severe hypercholesterolemia and a high risk of cardiovascular complications, who have not achieved the goal of treatment with low doses, and when it is expected that the benefits will outweigh the potential risks.

Application features

Pregnant women

Contraindicated.

Children

From the age of 10.

Drivers

You should refrain from driving or operating machinery.

Overdose

Several cases of overdose have been reported, the maximum dose taken was 3.6 g, and none of the patients showed any specific symptoms. All patients recovered without complications. In case of overdose, symptomatic and supportive measures should be taken, as there is no specific treatment.

Side effects

Cases of severe hypersensitivity syndrome have been reported, including some of the following manifestations: angioedema, lupus-like syndrome, polymyalgia rheumatica, dermatomyositis, vasculitis, thrombocytopenia, eosinophilia, increased erythrocyte sedimentation rate (ESR), arthritis and arthralgia, urticaria, photosensitivity, fever, flushing, dyspnea, and malaise.

Interaction

Concomitant use of potent CYP3A4 inhibitors (drugs that increase AUC by approximately 5-fold or more) such as itraconazole, ketoconazole, posaconazole, voriconazole, HIV protease inhibitors (e.g. nelfinavir), boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin and nefazodone is contraindicated.

Storage conditions

Store at a temperature not exceeding 30 °C in the original packaging.

Keep out of reach of children.

Shelf life - 3 years.