Simvastatin Stella 20mg (3 blisters x 10 tablets/box)

Indications

• Treatment of primary hypercholesterolaemia or mixed dyslipidaemia, as an adjunct to diet.
• Treatment of homozygous familial hypercholesterolaemia.
• Treatment of hypertriglyceridemia.
• Reduction of cardiovascular mortality and morbidity in patients with manifest atherosclerotic cardiovascular disease or diabetes mellitus.

Contraindications

• Known hypersensitivity to simvastatin or any ingredient in the formula.
• Active liver disease or unexplained persistent elevations of serum transaminases.
• Pregnancy and lactation.
• Concomitant administration of potent CYP3A4 inhibitors, gemfibrozil, ciclosporin, or danazol.
• In patients with homozygous familial hypercholesterolaemia, concomitant administration of lomitapide with doses > 40 mg simvastatin.

Compositon/Ingredients

Dosage and administration

• Hypercholesterolaemia: Start with 10 – 20 mg/day. Patients with LDL-C more than 45 % may start at 20 – 40 mg/day.
• Homozygous familial hypercholesterolaemia: Start with 40 mg/day. In patients taking lomitapide concomitantly with simvastatin, the maximum dose of simvastatin is 40 mg/day.
• Cardiovascular prevention: The usual dose is 20 to 40 mg/day in patients at high risk of coronary heart disease (CHD, with or without hyperlipidaemia).
• Concomitant therapy: Taking concomitantly with fibrates (gemfibrozil, fenofibrate), the maximum dose of simvastatin is 10 mg/day. Taking concomitantly with amiodarone, amlodipine, verapamil, diltiazem, the maximum dose of simvastatin is 20 mg/day.
• Moderate renal impairment, elderly: No dosage adjustment is necessary.
• Paediatric population: Doses should be individualized according to the recommended goal of therapy as recommended by the paediatric treatment recommendations.

Precaution

• Risk of myopathy/rhabdomyolysis.
• Caution with elderly, female gender, renal impairment, uncontrolled hypothyroidism, history of muscular disorders.
• If muscular pain, weakness or cramps occur, creatin kinase levels should be measured.
• If it is suspected a patient has developed interstitial lung disease, statin therapy should be discontinued.
• This medicine should not be used in patients with galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
• Driving/ operating machinery.

Storage

Store at temperature below 30°C, protect from light.