Fenofibrate Capsules USP (Micronized) 200mg Technical Specification:

Product Name:Fenofibrate Capsules USP (Micronized) 200mg
Brand Name:Generics
Strength:67mg, 134mg, 200mg
Dosage Form:Capsule (Hard-Gelatine)
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, Fibric acid agent.
Indication: Fenofibrate is used along with a proper diet to help lower “bad” cholesterol and fats (such as LDL, 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 USP (Micronized) 200mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Fenofibrate Capsules USP (Micronized) 200mg
    Each hard-gelatin capsule contains:
    Fenofibrate USP …………………….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 & WARNING:

CAUTION: Read enclosed leaflet before use.
Keep 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:  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.

Attach dispensing label as per end country.

 

 

 

 

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Fenofibrate Capsules USP (Micronized) 200mg
B. Fenofibrate Capsules USP (Micronized) 134mg
C. Fenofibrate Capsules USP (Micronized) 67mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Fenofibrate Capsules USP (Micronized) 200mg
Each hard-gelatin capsule contains:
Fenofibrate USP …………………….200mg
Excipients………………………...……q.s.
Colour: Titanium Dioxide


B. Fenofibrate Capsules USP (Micronized) 134mg
Each hard-gelatin capsule contains:
Fenofibrate USP…………………………...134mg
Excipients………………………………….... q.s.
Colour: Iron Oxide Red

C. Fenofibrate Capsules USP (Micronized) 67mg
Each hard-gelatin capsule contains:
Fenofibrate USP…………………………...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.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP 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: 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.
Attach dispensing label as per end country.