LIPANTIL Capsule Ref.[49984] Active ingredients: Fenofibrate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Mylan Products Ltd., 20 Station Close, Potters Bar, Herts, EN6 1TL, United Kingdom

Product name and form

Lipantil Micro 67 mg, capsules.

Pharmaceutical Form

Yellow, hard gelatin capsule.

Qualitative and quantitative composition

Each capsule contains 67 mg fenofibrate.

Excipients with known effect: each capsule contains 33.8 mg of lactose monohydrate.

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

Excipients:

Lactose monohydrate
Magnesium stearate
Pregelatinised starch
Sodium laurilsulfate
Crospovidone

Composition of the capsule shell:

Gelatin
Titanium dioxide (E171)
Quinoline yellow (E104)
Erythrosine (E127)

Pack sizes and marketing

Pack of 28, 56, 84, 90 capsules in blisters (PVC/Aluminium).

* Not all pack sizes may be marketed.

Marketing authorization holder

Mylan Products Ltd., 20 Station Close, Potters Bar, Herts, EN6 1TL, United Kingdom

Marketing authorization dates and numbers

PL 46302/0044

11 September 1997 / 10 September 2002

Drugs

Drug Countries
LIPANTIL Ireland, Malta, United Kingdom

© 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.