RAZTROL Tablet Ref.[50495] Active ingredients: Rupatadine

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2021  Publisher: RANBAXY PHARMACEUTICALS (PTY) LTD, 14 Lautre Road, Stormill, Ext. 1, Roodepoort, 1724, South Africa

Product name and form

RAZTROL (Tablets 10 mg).

Pharmaceutical Form

Tablet.

RAZTROL is a salmon coloured, 6,35 mm ± 0.1 mm round, biconvex, uncoated tablets, plain on both sides.

Qualitative and quantitative composition

Each tablet contains: Rupatadine fumarate 12,79 mg equivalent to rupatadine 10 mg.

For full list of excipients, see section 6.1.

Contains sugar: lactose monohydrate 60 mg per tablet.

Active Ingredient Description
Rupatadine

Rupatadine is a second-generation antihistamine, long-acting histamine antagonist, with selective peripheral H1-receptor antagonist activity. Some of the metabolites (desloratadine and its hydroxylated metabolites) retain an antihistaminic activity and may partially contribute to the overall efficacy of the drug.

List of Excipients

Iron oxide red
Iron oxide yellow
Lactose monohydrate
Magnesium stearate
Microcrystalline cellulose
Pre-gelatinised starch
Purified water

Pack sizes and marketing

RAZTROL tablets are packed in blister packs consisting of PVC/PVDC foil as a forming material and pre-printed aluminium foil as a lidding material. Each blister will contain 10 tablets. Blisters are packed in a carton in pack sizes of 10, 20 or 30 tablets.

Marketing authorization holder

RANBAXY PHARMACEUTICALS (PTY) LTD, 14 Lautre Road, Stormill, Ext. 1, Roodepoort, 1724, South Africa

Marketing authorization dates and numbers

55/5.7.1/0293

7 December 2021

Drugs

Drug Countries
RAZTROL South Africa

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