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ZIRTEK Allergy Film-coated tablets (2018)

Active ingredients: Cetirizine

Product Name and Form

Zirtek Allergy 10 mg film-coated tablets.

Pharmaceutical form

Film-coated tablets.

White, oblong, film-coated tablet, with breakline and Y-Y logo The tablet can be divided into 2 equal doses.

Qualitative and Quantitative Composition

Each film-coated tablet contains 10 mg cetirizine dihydrochloride.

Excipients with known effect: one film-coated tablet contains 66.40 mg lactose-monohydrate.

For the full list of excipients, see section 6.1.

Chemical substance
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

Microcrystalline cellulose
Lactose-monohydrate
Colloidal anhydrous silica
Magnesium stearate

Opadry Y-1-7000 which consists of:

Hydroxypropylmethylcellulose (E464)
Titanium dioxide (E171)
Macrogol 400

Pack sizes and Marketing

The tablets are enclosed in a transparent, colorless, inert PVC blister strip thermo-sealed with a lacquered aluminium foil. These blister strips are housed in a carton box.

Boxes of 1, 4, 5, 7, 10, 14, 15, 20, 21, 30, 40, 45, 50, 60, 90, 100 or 100 (10x10) tablets.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

UCB Pharma Ltd, 208 Bath Road, Slough, Berkshire, SL1 3WE

12 December 2005

Marketing authorization number:

PL 00039/0542