SIMCARD Film-coated tablet Ref.[50448] Active ingredients: Simvastatin

The patient must follow a cholesterol-lowering diet before initiation of, and while on SIMCARD therapy.

Hypercholesterolaemia

Adults

Initial dose: 10 mg daily as a single dose in the evening. The dose of SIMCARD should be reduced if LDL-cholesterol levels fall below 1,94 mmol/l, or total plasma cholesterol levels fall below 3,6 mmol/l.

Coronary heart disease

Adults

Initial dose: 20 mg daily as a single dose in the evening.

Dosage adjustments: If required, the dose should be adjusted at intervals of not less than 4 weeks, up to a maximum of 80 mg daily as a single dose in the evening. SIMCARD can be taken with meals or on an empty stomach.

Dosage in renal insufficiency

SIMCARD does not undergo significant renal excretion, therefore modification of dose should not be necessary in patient with mild to moderate renal insufficiency. In patients with severe renal insufficiency SIMCARD therapy should be closely monitored and doses above 10 mg daily should be implemented with caution.

Concomitant therapy

SIMCARD is effective alone or in combination with bile acid sequestrants. When both medicines are prescribed, SIMCARD should be given 1 hour before or 4 hours after cholestyramine administration (see section 4.5). A maximum daily dose of 10 mg SIMCARD is recommended in patients taking cyclosporin, fibrates or niacin or concomitantly (see section 4.5).

(See section 4.4 and section 4.8).

General measures should be adopted and liver should be monitored.

Treatment is symptomatic and supportive.

3 years.

Polyethylene (HDPE) containers and closures.

Keep container tightly closed. Store in a dry place, below 25˚C. Protect from light.

Do not remove the blisters from the outer carton until required for use.

White opaque polyethylene (HPDE) containers and closures (tamper evident) containing 28/30 tablets or white opaque PVC/aluminium blister packs containing 28/30 tablets per carton.

None.