LACROMID Film-coated tablet Ref.[49963] Active ingredients: Bezafibrate

Source: Υπουργείο Υγείας (CY)  Revision Year: 2018  Publisher: Remedica Ltd, Aharnon Street, Limassol Industrial Estate, 3056 Limassol, Cyprus

Product name and form

Lacromid 200 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

White, round, scored film-coated tablets with Remedica’s logo on one side.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Qualitative and quantitative composition

Each film-coated tablet contains bezafibrate 200 mg.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Bezafibrate

Bezafibrate lowers elevated blood lipids (triglycerides and cholesterol). Elevated VLDL and LDL are reduced by treatment with bezafibrate, whilst HDL-levels are increased. Furthermore, cholesterol biosynthesis is reduced by bezafibrate, which is accompanied by a stimulation of the LDL receptor-mediated lipoprotein catabolism.

List of Excipients

Core:

Povidone
Cellulose, microcrystalline
Sodium starch glycollate (Type A)
Silica, colloidal anhydrous
Magnesium stearate
Talc
Ethanol (96%)
Water, purified

Coating:

Hypromellose
Macrogol 400
Talc
Titanium dioxide E171

Pack sizes and marketing

PVC/Aluminium Blisters. Pack-size of 50 and 1000 film-coated tablets.

PP containers with PE closure. Pack-size 50 and 1000 film-coated tablets.

Not all pack-sizes may be marketed.

Marketing authorization holder

Remedica Ltd, Aharnon Street, Limassol Industrial Estate, 3056 Limassol, Cyprus

Marketing authorization dates and numbers

12845

Date of first authorization: 25 July 1990
Date of latest renewal: 02 December 2011

Drugs

Drug Countries
LACROMID Cyprus

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