| Product Name: | Rosuvastatin Calcium + Fenofibrate Tablets |
| Brand Name: | Generics |
| Strength: | 5+160mg, 10+160mg |
| Dosage Form: | Tablets (Film-coated) |
| Route of Administration: | Via oral Route |
| Packing: | 30s, 90s, 100s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Antilipemic agents, Antihyperlipidemic, Lipid-Lowering Agents, Statins. |
| Indication: | Fenofibrate is used together with a proper diet to reduce and treat high cholesterol and triglyceride (fat-like substances) levels in the blood. This may help prevent the development of pancreatitis (inflammation or swelling of the pancreas) caused by high levels of triglycerides in the blood. |
| 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:
- Rosuvastatin Calcium + Fenofibrate 5mg+160mg
- Rosuvastatin Calcium + Fenofibrate 10mg+160mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Rosuvastatin Calcium + Fenofibrate Tablet USP 5mg+160mg
Each Film-coated Tablet contains:
Rosuvastatin Calcium USP
Eq. to Rosuvastatin …………………5mg
Fenofibrate USP……………………160mg
Excipients…………………………. Q.s.
Colours: Ferric Oxide (red). - Rosuvastatin Calcium + Fenofibrate Tablet USP 10mg+67mg
Each Film-coated Tablet contains:
Rosuvastatin Calcium USP
Eq. to Rosuvastatin…………………10mg
Fenofibrate USP……………………160mg
Excipients…………………………. Q.s.
Colours: Pigment yellow 3.
THERAPEUTIC INDICATIONS:
Fenofibrate is used together with a proper diet to reduce and treat high cholesterol and triglyceride (fat-like substances) levels in the blood. This may help prevent the development of pancreatitis (inflammation or swelling of the pancreas) caused by high levels of triglycerides in the blood.
CAUTION & WARNING:
CAUTION:
Read the enclosed leaflet before use.
Keep the medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
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: As directed by the Physician.