FAMOPSIN 20mg Film-coated tablet Ref.[28193] Active ingredients: Famotidine

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

Product name and form

Famopsin 20 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Light brown, round, film-coated tablets.

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 famotidine 20 mg.

Excipient(s) with known effect:

This product contains lactose 67.4 mg.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Famotidine

Famotidine is a potent competitive H2-receptor antagonist. Famotidine has a rapid onset of action and, at the recommended doses, has a long duration of action and is highly effective at relatively low blood concentrations.

List of Excipients

Core:

Cellulose, microcrystalline
Lactose monohydrate
Maize starch
Povidone
Sodium starch glycolate (Type A)
Silica, colloidal anhydrous
Magnesium stearate

Film-coating:

Hypromellose
Macrogol 400
Titanium dioxide
Talc
Ferric oxide red E172
Ferric oxide yellow E172
Ferric oxide black E172

Pack sizes and marketing

PVC/Aluminium blisters. Pack-sizes of 30 and 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Marketing authorization dates and numbers

11971

Date of first authorization: 12 October 1988
Date of latest renewal: 10 December 2010

Drugs

Drug Countries
FAMOPSIN Cyprus, Singapore

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