Formula
Each film-coated tablet contains simvastatin 10 mg and excipients q.s. (butylated hydroxyanisole, anhydrous lactose, ascorbic acid, citric acid, microcrystalline cellulose, pregelatinized starch, magnesium stearate, film coating excipient).

Dosage form
Film-coated tablets.

Presentation
Box of 1 bottle x 50 film-coated tablets.
Box of 2 blisters x 14 film-coated tablets.

Indications
Hypercholesterolemia: Simvastatin is indicated for the reduction of elevated total and LDL cholesterol levels in patients with primary hypercholesterolemia (type IIa and IIb), when the response to diet and other measures alone have been inadequate.
Coronary heart disease: Simvastatin is indicated to reduce the risk of coronary death, non-fatal myocardial infarction and to reduce the risk of undergoing myocardial revascularization procedures. 

Contra-indications
Known hypersensitivity to any component of the drug; active liver disease or unexplained persistent elevations of serum transaminases; pregnancy and lactation. 

Precautions
Myopathy; unexplained serum transaminase elevation; severe renal dysfunction; children and the elderly (over 65 years of age).
Side effects
Simvastatin is well tolerated. Side effects have usually been mild and transient, manifested as abdominal pain, constipation, diarrhea, flatulence, asthenia, headache. Rare cases manifested as myopathy, hepatitis, cholestatic jaundice, pancreatitis, hypersensitive reactions, alteration of taste.
Inform the physician any side-effect occurs during the therapy.

Drug interactions
Risk of myopathy when simvastatin is concomitantly used with cytochrom P450 3A4 inhibitors such as immunosuppressive drugs (cyclosporine), azole antifungals (itraconazole, ketoconazole), macrolide antibiotics (erythromycin, clarithromycin), HIV protease inhibitors, antidepressant (nefazodone).

Simvastatin (at dose of 20 - 40 mg/day) and warfarin in concomitant use may modestly potentiate the effect of coumarin anticoagulants.
Simvastatin and digoxin in concomitant use may result in a slight elevation in plasma digoxin concentration. 

Dosage and administration
Initial dose: 5 - 10 mg, once a day in the evening. Patients requiring reductions in LDL cholesterol of 20% or more should be started at 10 mg/day. A starting dose of 5 mg should be considered for patients requiring smaller reductions and for the elderly. 
Adjustment of dosage: 5 - 40 mg/day, once a day in the evening. Adjustment of dosage should be made at intervals of 4 weeks or more. Maximum dose: 40 mg/day.
The patients should be placed on a standard cholesterol-lowering diet before receiving simvastatin and should continue on this diet during treatment with simvastatin.
Doses should be individualized according to baseline LDL cholesterol levels, the recommended goal of therapy and the patient’s response.

Attention: Patients who are taking immunosuppresive drugs concomitantly with simvastatin should start at 5 mg of simvastatin and should not exceed 10 mg/day.
Concomitant therapy: Simvastatin is effective alone or when used concomitantly with bile-acid sequestrants. Use of simvastatin with fibrate-type drugs such as gemfibrozil or clofibrate should generally be avoided.

Shelf-life
36 months.

Storage
Store in a dry and cool place (< 25 degree C). Keep out of reach of children.

Specifications: in-house

Prescription only medicine.
Read leaflet carefully before use. For more information, consult your physician.