| Product Name: | Simvastatin Tablets USP 40mg |
| Brand Name: | Generics |
| Strength: | 20mg, 40mg |
| Dosage Form: | Tablets (Film-coated) |
| Route of Administration: | Via oral route |
| Packing: | 30s, 90s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Antihyperlipidemic, Anti-hypertensive, Cardiology, Cardiovascular. |
| Indication: | Simvastatin is used together with diet, weight loss, and exercise to reduce the risk of heart attack and stroke and to decrease the chance that heart surgery will be needed in people who have heart disease or who are at risk of developing heart disease. |
| Storage: | Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect it from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Simvastatin Tablets USP 20mg
- Simvastatin Tablets USP 40mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Simvastatin Tablets USP 20mg
Each film-coated tablet contains:
Simvastatin USP……………….20mg
Excipients: …………………………. Q.S.
Colours: Iron Oxide Yellow. - Simvastatin Tablets USP 40mg
Each film-coated tablet contains:
Simvastatin USP …………………. 40mg
Excipients……………………………. Q.S.
Colours: Iron Oxide Black
THERAPEUTIC INDICATIONS:
Simvastatin is used together with diet, weight loss, and exercise to reduce the risk of heart attack and stroke and to decrease the chance that heart surgery will be needed in people who have heart disease or who are at risk of developing heart disease.
CAUTION & WARNING:
CAUTION: Using this medicine while you are pregnant can harm your unborn baby.
Read the enclosed leaflet before use.
Keep the medicine out of reach of children.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
Any unused product or waste material should be disposed of in accordance with local requirements.
STORAGE & DOSAGE:
Storage: Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect it from moisture.
Dosage:
Usual dosage range: 5-40mg orally once/day
Initial: 10-20mg orally once/day in the evening
Patients at high CHD risk: start 40mg/day
Children under 10 years: Safety & efficacy not established.