LOPID Film-coated tablet Ref.[8154] Active ingredients: Gemfibrozil

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

Product name and form

Lopid 600 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Description

Lopid 600 mg: white, biconvex, oval, film-coated tablets

Qualitative and quantitative composition

Each film-coated tablet contains 600 mg of gemfibrozil.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Gemfibrozil

Gemfibrozil is a lipid regulating agent which regulates lipid fractions. Gemfibrozil stimulates the peripheral lipolysis of triglyceride rich lipoproteins such as VLDL and cholymicrons by stimulation of LPL. Gemfibrozil also inhibits synthesis of VLDL in the liver.

List of Excipients

Core tablet:

Microcrystalline cellulose
Pregelatinised starch
Colloidal silica (anhydrous) (E551)
Polysorbate 80 (E433)
Sodium starch glycollate
Magnesium stearate

Tablet coating:

Hydroxypropylmethylcellulose (E464)
Titanium dioxide (E171)
Talc (E553b)
Polydimethyl siloxane
Polyethylene glycol 6000

Pack sizes and marketing

Film-coated tablets: PVC/Aluminium blisters with 14, 20, 28, 30, 50, 56, 60, 98, 100, 196, 500 and 600 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

Marketing authorization dates and numbers

PL 00057/0535

Renewal of authorization: 04 April 2010

Drugs

Drug Countries
LOPID Ecuador, Spain, Finland, Hong Kong, Ireland, Italy, Mexico, Netherlands, Turkey, United Kingdom, United States, South Africa

© 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.