| Product Name: | Fenofibrate Capsules IP |
| Brand Name: | FanaCor-Taj |
| Strength: | 145mg, 160mg, 200mg |
| Dosage Form: | Capsule (Hard Gelatine) |
| Route of Administration: | Via oral Route |
| Packing: | 100s, 150s, 200s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Regulatory Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Antihyperlipidemic, Antilipemic agents, Fibric acid agents. |
| Indication: | Fenofibrate 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. |
| Storage: | Protect from moisture at a temperature not exceeding 25˚C. Do not freeze. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Fenofibrate Capsules IP 145mg
- Fenofibrate Capsules IP 160mg
- Fenofibrate Capsules IP 200mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Fenofibrate Capsules IP 145mg
Each hard-gelatin capsule contains:
Fenofibrate IP…………………….145mg
Excipients………………………………q.s.
Approved colors used in capsule shells. - Fenofibrate Capsules IP 160mg
Each hard-gelatin capsule contains:
Fenofibrate IP…………………….160mg
Excipients………………………………q.s.
Approved colors used in capsule shells. - Fenofibrate Capsules IP 200mg
Each hard-gelatin capsule contains:
Fenofibrate IP…………………….200mg
Excipients………………………………q.s.
Approved colors used in capsule shells.
THERAPEUTIC INDICATIONS:
Fenofibrate is used for the Treatment of severe hypertriglyceridemia with or without low HDL cholesterol, Mixed hyperlipidemia when a statin is contraindicated or not tolerated, and in Mixed hyperlipidemia in patients at high cardiovascular risk in addition to a statin when triglycerides and HDL cholesterol are not adequately controlled improve Your cholesterol numbers.
CAUTION & WARNING:
CAUTION: Not be used in children below 12 years of age expect under medical advice.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Do not take this product during the last three months of pregnancy unless directed by a doctor. Aspirin taken near the time of delivery may cause bleeding problems to both mother-child
SCHEDULE “H” Prescription Drug Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
STORAGE & DOSAGE:
Storage: Protect form moisture at a temperature not exceeding 25˚C.Do not freeze.
Dosage: As Directed by the Physician once a day.