a) Fenofibrate Capsules IP (Micronized) 200mg
b) Fenofibrate Capsules IP (Micronized) 67mg
GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Fenofibrate Capsules IP (Micronized) 200mg
Each hard-gelatin capsule contains:
Fenofibrate IP …………………….200mg
Excipients………………………...……q.s.
Colour: Titanium Dioxide
b) Fenofibrate Capsules IP (Micronized) 67mg
Each hard-gelatin capsule contains:
Fenofibrate IP…………………………...67mg
Excipients…………………………………... q.s.
Colour: Iron Oxide Black
Each hard-gelatin capsule contains:
Fenofibrate IP …………………….200mg
Excipients………………………...……q.s.
Colour: Titanium Dioxide
b) Fenofibrate Capsules IP (Micronized) 67mg
Each hard-gelatin capsule contains:
Fenofibrate IP…………………………...67mg
Excipients…………………………………... q.s.
Colour: Iron Oxide Black
THERAPEUTIC INDICATIONS:
Fenofibrate is indicated as an adjutant to diet and other non-pharmacological treatment (e.g., exercise, weight reduction) for the following:
– Treatment of severe hypertriglyceridemia with or without low HDL cholesterol.
– Mixed hyperlipidemia when a statin is contraindicated or not tolerated.
– Mixed hyperlipidemia in patients at high cardiovascular risk in addition to a statin when triglycerides and HDL cholesterol are not adequately controlled.
– Treatment of severe hypertriglyceridemia with or without low HDL cholesterol.
– Mixed hyperlipidemia when a statin is contraindicated or not tolerated.
– Mixed hyperlipidemia in patients at high cardiovascular risk in addition to a statin when triglycerides and HDL cholesterol are not adequately controlled.
CAUTION & SCHEDULE:
CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
STORAGE & DOSAGE:
Storage: Keep the container tightly closed in order to protect from moisture. Store in the original package. Do not store above 25°C.
Dosage: As directed by the Physician.
Dosage: As directed by the Physician.
Fenofibrate Capsules IP (Micronized) FanaCor-Taj 200mg Technical Specification:
| Product Name: | Fenofibrate Capsules IP (Micronized) |
| Brand Name: | FanaCor-Taj |
| Strength: | 67mg, 200mg |
| Dosage Form: | Capsule (Hard-Gelatine) |
| Route of Administration: | Via oral route |
| Packing: | 30s,90s,100s. |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Stability Study |
| Therapeutic use: | Antilipemic agents, Antihyperlipidemic, Fibric acid agent. |
| 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: | Store in the original package. Do not store above 25°C. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Fenofibrate Capsules IP (Micronized) 200mg (FanaCor-Taj)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Fenofibrate Capsules IP (Micronized) 200mg (FanaCor-Taj)
Each hard-gelatin capsule contains:
Fenofibrate IP …………………….200mg
Excipients………………………………q.s.
Colour: Titanium Dioxide
THERAPEUTIC INDICATIONS:
Fenofibrate is indicated as an adjutant to diet and other non-pharmacological treatment (e.g., exercise, weight reduction) for the following:
– Treatment of severe hypertriglyceridemia with or without low HDL cholesterol.
– Mixed hyperlipidemia when a statin is contraindicated or not tolerated.
– Mixed hyperlipidemia in patients at high cardiovascular risk in addition to a statin when triglycerides and HDL cholesterol are not adequately controlled.
CAUTION & SCHEDULE:
CAUTION:
Read the enclosed leaflet before use.
Keep the medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
STORAGE & DOSAGE:
Storage: Keep the container tightly closed in order to protect it from moisture. Store in the original package. Do not store above 25°C.
Dosage: As directed by the Physician.
