CLOTAM RAPID Tablet Ref.[8274] Active ingredients: Tolfenamic acid

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: A/S GEA Farmaceutisk Fabrik, Edvard Thomsens Vej 14, 2300, Copenhagen S, Denmark

Product name and form

Clotam Rapid.

Tolfenamic Acid 200mg Tablets.

Pharmaceutical Form

Tablets.

Qualitative and quantitative composition

Tolfenamic acid 200 mg.

Active Ingredient Description
Tolfenamic acid

Tolfenamic acid is a NSAID with anti-inflammatory, analgesic, and antipyretic effects. Tolfenamic acid is a prostaglandin synthesis inhibitor and a leukotriene synthesis inhibitor.

List of Excipients

Maize starch
Sodium starch glycollate (Type A)
Macrogol 6000
Alginic acid
Cellulose, microcrystalline
Croscarmellose sodium
Silica, colloidal anhydrous
Sodium stearyl fumarate

Pack sizes and marketing

Blister card:

Cover foil: 20 μm Al foil.

Form foil: 250 μm PVC foil.

HDPE tablet container with LDPE closure.

Pack sizes: 3, 10 and 30 tablets.

Marketing authorization holder

A/S GEA Farmaceutisk Fabrik, Edvard Thomsens Vej 14, 2300, Copenhagen S, Denmark

Marketing authorization dates and numbers

PL 04012/0043

25 April 1997

Drugs

Drug Countries
CLOTAM Estonia, Finland, United Kingdom

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