ULCEDINE Film coated table Ref.[28024] Active ingredients: Famotidine

Source: Υπουργείο Υγείας (CY)  Revision Year: 2018  Publisher: Codal-Synto Ltd., 21 Constantinoupoleos St., 3011 Limassol, Cyprus

Product name and form

Ulcedine 20 mg film coated tablets.

Ulcedine 40 mg film coated tablets.

Pharmaceutical Form

Film coated tablet.

Ulcedine 20mg film coated tablets are round, brown film coated tablets for oral administration.

Ulcedine 40mg film coated tablets are round, brown, film coated tablets for oral administration.

Qualitative and quantitative composition

Ulcedine 20mg film coated tablets contain 20mg of famotidine.

Ulcedine 40mg film coated tablets contain 40mg of famotidine.

Excipient with known effect: lactose.

Each Ulcedine 20mg film coated tablet contains 80mg lactose.

Each Ulcedine 40mg film coated tablet contains 140mg 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

The film coated tablets also contain microcrystalline cellulose, lactose, croscarmellose sodium, silicon dioxide, magnesium stearate, titanium dioxide (E172), hydroxypropylmethyl cellulose, polyethylene glycol 6000, polyethylene glycol 400 and iron oxides yellow, black and red (E172).

Pack sizes and marketing

Polyvinylchloride – aluminium blisters with a patient information leaflet in a carton.

Ulcedine 20mg is available in cartons of 30 and 100 tablets and Ulcedine 40mg in cartons of 20 and 100 tablets. For both strengths securitainers of 500 and 1000 tablets are also available.

Not all pack sizes may be marketed.

Marketing authorization holder

Codal-Synto Ltd., 21 Constantinoupoleos St., 3011 Limassol, Cyprus

Marketing authorization dates and numbers

Ulcedine 20mg film coated tablets: 19961
Ulcedine 40mg film coated tablets: 20001

Ulcedine 20mg film coated tablets:

Date of first authorization: 29/12/2005 / Renewal: 09/10/2012

Ulcedine 40 mg film coated tablets:

Date of first authorization: 29/12/2005 / Renewal: 23/04/2014

Drugs

Drug Countries
ULCEDINE Cyprus, Hong Kong

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