GRANTRYL Film-coated tablet Ref.[51214] Active ingredients: Granisetron

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2022  Publisher: Acino Pharma (Pty) Ltd, 106 16th Road, Midrand, 1686

Product name and form

GRANTRYL 1 mg film-coated tablets.

GRANTRYL 2 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablets

GRANTRYL 1 mg: triangular, white, biconvex film-coated tablets, with ‘G1’ engraved on one side OR triangular, white, biconvex film-coated tablets, with “C” debossed on one side and “45” debossed on the other side.

GRANTRYL 2 mg: triangular, white, biconvex film-coated tablets, with ‘G2’ engraved on one side OR triangular, white, biconvex film-coated tablets, with “C” debossed on one side and “46” debossed on the other side.

Qualitative and quantitative composition

Each film-coated tablet GRANTRYL 1 mg contains 1,0 mg of granisetron as granisetron hydrochloride.

Contains sugar: Lactose anhydrous 69,38 mg.

Each film-coated tablet of GRANTRYL 2 mg contains 2,0 mg of granisetron as granisetron hydrochloride.

Contains sugar: Lactose anhydrous 138,76 mg.

For full list of excipients, see section 6.1.

Active Ingredient Description
Granisetron

Granisetron is a potent anti-emetic and highly selective antagonist of 5-hydroxytryptamine (5HT3 receptors). Pharmacological studies have demonstrated that granisetron is effective against nausea and vomiting as a result of cytostatic therapy.

List of Excipients

GRANTRYL 1 mg: Hypromellose, lactose anhydrous, macrogol, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, sodium starch glycolate, talc, titanium dioxide (C.I. 77891).

GRANTRYL 2 mg: Hypromellose, lactose anhydrous, macrogol, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, sodium starch glycolate, talc, titanium dioxide (C.I. 77891).

Pack sizes and marketing

1, 5, 10 and 100 film-coated tablets are packed in a white opaque polyvinyl chloride film blister strip sealed with an aluminium foil backing. The blister strips are packed into an outer cardboard carton together with a leaflet.

Not all pack sizes are necessarily marketed.

Marketing authorization holder

Acino Pharma (Pty) Ltd, 106 16th Road, Midrand, 1686

Marketing authorization dates and numbers

GRANTRYL 1 mg: 42/5.7.2/1007
GRANTRYL 2 mg: 42/5.7.2/1008

GRANTRYL 1 mg: 09 October 2009
GRANTRYL 2 mg: 09 October 2009

Drugs

Drug Countries
GRANTRYL South Africa

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