CETRIZ Film coated tablet Ref.[49821] Active ingredients: Cetirizine

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220 Hafnarfjรถrdur, Iceland

Product name and form

Cetriz 10mg Film-coated Tablets.

Pharmaceutical Form

Film coated tablet.

Film-coated, white or almost white convex, oval shaped, tablets. Scored on one side. The tablet can be divided into 2 equal doses.

Qualitative and quantitative composition

Each film-coated tablet contains cetirizine dihydrochloride 10 mg.

Excipients with known effect: contains lactose monohydrate 117.00 mg.

For the full list of excipients, see 6.1.

Active Ingredient Description
Cetirizine

Cetirizine, a human metabolite of hydroxyzine, is a potent and selective antagonist of peripheral H1-receptors. In vitro receptor binding studies have shown no measurable affinity for other than ฮ—1-receptors.

List of Excipients

Tablet core:

Cellulose, microcrystalline
Lactose monohydrate
Crospovidone
Silica, colloidal anhydrous
Magnesium stearate

Film coating:

Hypromellose
Macrogol stearate
Cellulose, microcrystalline
Propylene glycol
Titanium dioxide E171

Pack sizes and marketing

Aluminium/Aluminium blisters.

Pack size: 7,10,14, 28 or 30 Tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220 Hafnarfjรถrdur, Iceland

Marketing authorization dates and numbers

PA1380/054/001

Date of first authorisation: 07 July 2006
Date of last renewal: 07 July 2011

Drugs

Drug Countries
CETRIZ Hong Kong, Ireland

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