CETRINE Film-coated tablet Ref.[50661] Active ingredients: Cetirizine

Source: Health Products Regulatory Authority (IE) Revision Year: 2019 Publisher: Rowex Ltd, Bantry, Co. Cork, Ireland

Product name and form

Cetrine 10 mg Film-coated Tablets.

Pharmaceutical Form
Film-coated tablets. White, oblong film-coated tablet, scored on one side. The scoreline is to allow the tablet to be divided into equal halves.

Qualitative and quantitative composition

Each film-coated tablet contains 10 mg cetirizine dihydrochloride.

Excipients with known effect: Also contains 81.8mg lactose monohydrate.

For the full list of excipients, see section 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 Η₁-receptors.

List of Excipients
Lactose monohydrate Microcrystalline cellulose Silica, colloidal anhydrous Magnesium stearate For film-coating: Lactose monohydrate Titanium dioxide (E171) Hypromellose Macrogol 4000

Pack sizes and marketing

Cetrine 10 mg tablets are packed into PVC/Al strips and inserted into a carton.

Cetrine 10 mg tablets are available in packs of 30 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Rowex Ltd, Bantry, Co. Cork, Ireland

Marketing authorization dates and numbers

PA0711/075/001

Date of first authorisation: 06 August 2004
Date of last renewal: 06 August 2009

Drugs

Drug	Countries
CETRINE	Ecuador, Ireland, Malta

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