ORPHENADRINE HYDROCHLORIDE Oral solution Ref.[8583] Active ingredients: Orphenadrine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2013  Publisher: Rosemont Pharmaceuticals Ltd., Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK

Product name and form

Orphenadrine Hydrochloride 50mg/5ml Oral Solution.

Pharmaceutical Form

Oral solution.

Qualitative and quantitative composition

Orphenadrine hydrochloride 50mg/5ml.

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.
List of Excipients

Methyl hydroxybenzoate
Propyl hydroxybenzoate
Propylene glycol
Liquid maltitol
Sorbitol solution 70%
Saccharin sodium
Blackcurrant flavour
Aniseed flavour
Citric acid monohydrate
Sodium citrate
Purified water

Pack sizes and marketing

Bottles: Amber (Type III) glass.

Closures: HDPE, EPE wadded, tamper evident, child resistant closure.

Capacity: 150ml

Marketing authorization holder

Rosemont Pharmaceuticals Ltd., Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK

Marketing authorization dates and numbers

PL 00427/0076

15.05.90/09.04.97/8.4.02

 
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