ULCERAN Film-coated tablet Ref.[28255] Active ingredients: Famotidine

Source: Υπουργείο Υγείας (CY)  Revision Year: 2018  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

Ulceran 20 mg film-coated tablets.

Ulceran 40 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Ulceran tablets 20 mg are round, brown, film-coated tablets.

Ulceran tablets 40 mg are round, brown, film-coated tablets.

Qualitative and quantitative composition

Ulceran tablets 20 mg contain 20 mg of famotidine.

Ulceran tablets 40 mg contain 40 mg of famotidine.

Excipient with known effect: lactose.

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

Microcrystalline cellulose
Lactose
Croscarmellose sodium
Silicon dioxide
Magnesium stearate
Titanium dioxide
Hydroxypropylcellulose
Polyethylene glycol 400
Iron oxides yellow, black and red, E172

Pack sizes and marketing

Polyvinylchloride-aluminium blisters with a patient information leaflet in a carton and securitainers are available.

20 mg: 20, 30, 100 packs are available and securitainers of 250 and 500 tablets are also available.

40 mg: 10, 50,100 packs are available and securitainers of 250 and 500 tablets are also available.

Not all pack sizes may be marketed.

Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

Ulceran 20 mg: 11010
Ulceran 40 mg: 11011

Ulceran 20 mg: 14.01.1987 / 20.03.2009
Ulceran 40 mg: 14.01.1987 / 20.03.2009

Drugs

Drug Countries
ULCERAN Cyprus, Hong Kong

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