NORGESIC Tablet, uncoated Ref.[50936] Active ingredients: Orphenadrine Paracetamol

Source: Pharmaceutical Benefits Scheme (AU)  Revision Year: 2021  Publisher: iNova Pharmaceuticals (Australia) Pty Limited, Level 10, 12 Help Street, Chatswood NSW 2067, Australia, Tel: 1800 630 056

Product name and form

NORGESIC (Orphenadrine and paracetamol).

Pharmaceutical Form

Tablet, uncoated.

White, scored, immediate release tablets marked N/C on one side and no markings on the other side.

Qualitative and quantitative composition

Orphenadrine citrate 35 mg and paracetamol 450 mg tablets.

For the full list of excipients, see Section 6.1 List of excipients.

Physicochemical property

Orphenadrine citrate is white or almost white, crystalline powder. It is sparingly soluble in water, and slightly soluble in alcohol. Paracetamol is a white or almost white, crystalline powder that is sparingly soluble in water and freely soluble in alcohol.

Chemical structure

Orphenadrine citrate

Chemical name: (RS)-N,N-Dimethyl-2-[(2-methylphenyl)phenylmethoxy]ethanamine dihydrogen 2-hydroxypropane-1,2,3-tricarboxylate

Chemical structure:

Paracetamol

Chemical name: N-(4-Hydroxyphenyl)acetamide

Chemical structure:

CAS number

Orphenadrine citrate: 4682-36-4

Paracetamol: 103-90-2

Active Ingredient Description
Orphenadrine

Orphenadrine, which is a congener of diphenhydramine without sharing its soporific effect, is an anti-muscarinic agent. Orphenadrine is used as the hydrochloride in the symptomatic treatment of Parkinsonism.

Paracetamol

Paracetamol is a medication used to treat pain and fever. It does appear to selectively inhibit COX activities in the brain, which may contribute to its ability to treat fever and pain.

List of Excipients

Microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica, gelatin and pregelatinised maize starch.

Pack sizes and marketing

PP jars with PP child-resistant closure: 8 (sample pack), 24, 100, and 500s#

PVC/Al blisters: 8 (sample pack), 24, 100’s.

# - not marketed.

Marketing authorization holder

iNova Pharmaceuticals (Australia) Pty Limited, Level 10, 12 Help Street, Chatswood NSW 2067, Australia, Tel: 1800 630 056

Marketing authorization dates and numbers

4 July 1991

Drugs

Drug Countries
NORGESIC Austria, Finland, Hong Kong, Malta, New Zealand, Singapore

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