ALFOXAN Film-coated tablet Ref.[28108] Active ingredients: Mefenamic acid

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

Product name and form

Alfoxan 500 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Yellow, oval, film-coated tablets with Remedica’s logo on one side.

Qualitative and quantitative composition

Each film-coated tablet contains 500 mg mefenamic acid.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Mefenamic acid

Mefenamic acid is a non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic and antipyretic properties.

List of Excipients

Core:

Cellulose, microcrystalline
Povidone
Glycerol
Sodium laurilsulfate
Silica, colloidal anhydrous
Magnesium stearate

Coating:

Hypromellose
Macrogol 400
Titanium dioxide
Talc
Ferric oxide yellow E172
Quinoline yellow aluminium lake E104

Pack sizes and marketing

PVC/Aluminium blisters. Pack sizes of 20 and 100 film-coated tablets.

PP containers with PE closure. Pack sizes of 100 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

14417

Date of first authorization: 21 October 1993
Date of latest renewal: 07 October 2013

Drugs

Drug Countries
ALFOXAN Cyprus, Hong Kong, Malta, Singapore

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