Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2023 Publisher: SUN PHARMA UK LIMITED, 6-9 The Square, Stockley Park, Uxbridge, UB11 1FW, United Kingdom
Fenofibrate 200 mg capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule. Orange cap/orange body, self locked hard gelatin capsules of size ‘0’ imprinted with ‘FB200’ on cap and body containing white to off white granular powder. |
Each capsule contains 200 mg micronised fenofibrate.
Excipient with known effect: Each capsule contains 46.34 mg lactose monohydrate. This capsule also contains sunset yellow FCF (E110).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Fenofibrate |
Fenofibrate is a fibric acid derivative whose lipid modifying effects reported in humans are mediated via activation of Peroxisome Proliferator Activated Receptor type α (PPARα). Through activation of PPARα, fenofibrate increases lipolysis and elimination of atherogenic triglyceride rich particles from plasma by activating lipoprotein lipase and reducing production of Apoprotein C-III. |
| List of Excipients |
|---|
|
<>Intragranular: Sodium lauryl sulphate Extragranular: Crospovidone Capsule: Gelatin Printing Ink: Shellac glaze |
Blister strip of clear transparent PVC film coated with PVdC on the inner side with a backing of aluminium foil.
Pack size of 10, 14, 20, 28, 30, 56, 60 or 90 capsules. Not all pack sizes may be marketed.
SUN PHARMA UK LIMITED, 6-9 The Square, Stockley Park, Uxbridge, UB11 1FW, United Kingdom
PL 14894/0368
01/01/2012
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
