| Product Name: | Choline Fenofibrate Delayed-Release Capsule |
| Brand Name: | Generics |
| Strength: | 45mg, 135mg |
| Dosage Form: | Capsule (Hard-Gelatine) |
| Route of Administration: | Via oral Route |
| Packing: | 90s, 100s, 500s, 1000s |
| 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, Cardiovascular |
| Indication: | Feno fabric acid is used along with a proper diet to help lower “bad” cholesterol and fats (such as LDL, and triglycerides) and raise “good” cholesterol (HDL) in the blood. It works by increasing the natural substance (enzyme) that breaks down fats 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:
- Choline Fenofibrate Delayed-ReleaseCapsule 45mg
- Choline Fenofibrate Delayed-Release Capsule 135mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Choline Fenofibrate Delayed-ReleaseCapsule 45mg
Each delayed-release tablet contains:
Choline Fenofibrate
Equivalent to Fenofibrate acid…………45mg
Excipients……………………………. q.s.
Color: Ferric Oxide Yellow USP-NF - Choline Fenofibrate Delayed-Release Capsule 135mg
Each delayed-release tablet contains:
Choline Fenofibrate
Equivalent to Fenofibrate acid…………135mg
Excipients……………………………. q.s.
Color: Titanium Dioxide IP
THERAPEUTIC INDICATIONS:
Fenofibric acid is used along with a proper diet to help lower “bad” cholesterol and fats (such as LDL, and triglycerides) and raise “good” cholesterol (HDL) in the blood. It works by increasing the natural substance (enzyme) that breaks down fats 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.