CETIZAL Film-coated tablet Ref.[50452] Active ingredients: Levocetirizine

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2022  Publisher: Ranbaxy Pharmaceuticals (Pty) Ltd, a Sun Pharma Company, 14 Lautre Road, Stormill Ext 1, Roodepoort, 1724, South Africa

Product name and form

CETIZAL 5 Film-coated Tablets.

Pharmaceutical Form

Film-coated tablet: White, film-coated, scored, round, biconvex tablets debossed with ‘161’ on one side and ‘H’ on other side.

Qualitative and quantitative composition

Each film-coated tablet contains levocetirizine dihydrochloride 5 mg.

Contains sugar: Lactose monohydrate 65,71 mg.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Levocetirizine

Levocetirizine, the ® enantiomer of cetirizine, is a potent and selective antagonist of peripheral H1-receptors. Pharmacodynamic studies in healthy volunteers demonstrate that, at half the dose, levocetirizine has comparable activity to cetirizine, both in the skin and in the nose.

List of Excipients

Tablet core:

Colloidal anhydrous silica
Lactose monohydrate
Magnesium stearate
Microcrystalline cellulose

Film-coat:

Titanium dioxide
Hypromellose
Macrogol/polyethylene glycol 400
Polysorbate 80

Pack sizes and marketing

White opaque HDPE container with white opaque polypropylene, plastic cap containing 30 or 180 tablets.

Cold form blister pack comprising of cold formable laminated film with a backing of hard tempered plain silver aluminium foil containing 10 tablets.

Marketing authorization holder

Ranbaxy Pharmaceuticals (Pty) Ltd, a Sun Pharma Company, 14 Lautre Road, Stormill Ext 1, Roodepoort, 1724, South Africa

Marketing authorization dates and numbers

46/5.7.1/0329

06 August 2015

Drugs

Drug Countries
CETIZAL Hong Kong, South Africa

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