RUBIFEN Immediate release tablet, Sustained release tablet Ref.[50684] Active ingredients: Methylphenidate

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2022  Publisher: AFT Pharmaceuticals Limited, PO Box 33-203, Takapuna, Auckland 0740, Phone: 0800 423 823

Product name and form

Rubifen: Methylphenidate hydrochloride (USP) 5 mg, 10 mg and 20 mg.

Rubifen SR: Methylphenidate hydrochloride (USP) 20 mg sustained release tablets.

Pharmaceutical Form

Rubifen immediate release 5, 10 and 20 mg tablets: round white tablet with slightly bevelled edges, marked RU-5, RU-10 or RU-20 containing 5 mg, 10 mg and 20 mg methylphenidate respectively with a score mark on the 10 mg tablets.

Rubifen sustained release 20 mg tablets: oblong white or white-cream smooth tablet containing 20 mg methylphenidate in a modified release formulation.

Qualitative and quantitative composition

Each 5mg tablet contains methylphenidate 5mg.

Each 10mg tablet contains methylphenidate 10mg.

Each 20mg tablet contains methylphenidate 20mg.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Methylphenidate

Methylphenidate HCl is a mild central nervous system (CNS) stimulant. The mode of therapeutic action in Attention Deficit Hyperactivity Disorder (ADHD) is not known. Methylphenidate is thought to block the reuptake of noradrenaline and dopamine into the presynaptic neurone and increase the release of these monoamines into the extraneuronal space.

List of Excipients

Rubifen (5 mg, 10 mg and 20 mg) contains calcium hydrogen phosphate dehydrate magnesium stearate, maize starch, and microcrystalline cellulose.

Rubifen SR (20 mg) contains cetyl alcohol, ethylcellulose, lactose, magnesium stearate, and opadry white Y-1-7000.

Pack sizes and marketing

Rubifen (5 mg, 10 mg and 20 mg): Blister pack, PVC/Al, 30 tablets.

Rubifen SR (20 mg): Blister pack, PVC/PVdC AL (10 tbs/blister), 30 tablets.

Marketing authorization holder

AFT Pharmaceuticals Limited, PO Box 33-203, Takapuna, Auckland 0740, Phone: 0800 423 823

Marketing authorization dates and numbers

16/03/2000

Drugs

Drug Countries
RUBIFEN Spain, Lithuania, Malta, New Zealand, Singapore

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