Biorphen

Orphenadrine Hydrochloride BP 25 mg/5mL

An anise scented and flavoured clear colourless aqueous liquid.

Parkinsonism, particularly with apathy and depression, and drug induced extrapyramidal syndrome.

Oral dose

Adult and Elderly:

150 mg daily in divided doses. Maximum dose 400mg daily. Optimal dose range 150 to 300 mg; this is usually achieved by raising the dose to 50 mg every two to three days.

Children:

Not recommended.

Hypersensitivity to orphenadrine, or to any of the excipients.

Glaucoma, prostatic hypertrophy, urinary retention, porphyria.

Caution in renal and hepatic disease.

Antimuscarinic agents, including orphenadrine, should be used with caution in patients with pre-existing tachycardia, (e.g. in heart failure, thyrotoxicosis) as they may cause further acceleration of the heart rate.

Anti-muscarinic agents such as orphenadrine are not effective in the treatment of tardive dyskinesia which may be made worse, and should not be used in patients with this condition.

Avoid abrupt discontinuation of treatment.

Contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

May additionally increase anticholinergic activity.

As with other similar agents, the antimuscarinic effects of orphenadrine may be enhanced by the concomitant administration of other medications with antimuscarinic properties, such as antihistamines, antispasmodics, tricyclic antidepressants, phenothiazines, dopaminergic anti-parkinsonian drugs including amantadine, and anti-arrhythmics such as disopyramide. Although the additive effect may be minor, there is the potential for development of severe constipation and ileus, atropine-like psychoses and heat stroke.

Due to the anti-muscarinic effects of orphenadrine on the gastrointestinal tract, a reduction in gastric motility may occur which may affect the absorption of other orally administered drugs.

No studies with Biorphen have been carried out, therefore the drug should only be used in pregnancy if there is no safer alternative.

It is not known whether orphenadrine passes into the breast milk, therefore mothers should refrain from breast feeding whilst taking Biorphen.

Patients should be warned of the potential hazards of driving or operating machinery if they experience blurred vision.

Occasionally dry mouth, disturbances of visual accommodation, gastro-intestinal disturbances, dizziness and micturition difficulties may occur; these usually disappear spontaneously or may be controlled by a slight reduction in dosage. Less commonly, tachycardia, hypersensitivity, nervousness, euphoria, hallucinations, confusion and co-ordination disturbances and insomnia may be seen.

Effects seen on overdose are anti-cholinergic in nature and include agitation, confusion, hallucinations, incoordination, delirium, tachycardia and occasionally convulsions. Fatalities have been reported. Gastric lavage, emetic and high enema is recommended. Cholinergics may be useful.

Orphenadrine is a tertiary amine antimuscarinic agent.

Orphenadrine is readily absorbed from the gastro-intestinal tract and is almost completely metabolised, to at least 8 metabolites. It is mainly excreted in the urine.

No formal preclinical studies have been undertaken with Biorphen, as its active ingredient is a well established pharmaceutical.

Sorbitol, glycerol, anise water condensed, saccharin sodium, Tween 20, benzoic acid solution, water.

None known.

24 months.

None.

200 ml and 1000 ml amber glass bottles with polycone lined closures.

None stated.

Alliance Pharmaceuticals Ltd

Avonbridge House

Bath Road

Chippenham

Wiltshire

SN15 2BB

PL16853/0022

04 April 2002

28^th May 2008

Alliance, Alliance Pharmaceuticals and associated devices are registered Trademarks of Alliance Pharmaceuticals Ltd.