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

Use with caution in the elderly (see Section 4.2).

When used alone or with analgesics, pain or skeletal muscle spasms have been reported.

Use with caution in conditions characterised by tachycardia. Anti-muscarinic agents, such as 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.

Care should be taken when using in patients with concomitant hypertension, cardiac, renal or hepatic dysfunction.

Use with caution in patients with micturition difficulties and in pregnancy and breastfeeding.

Avoid abrupt discontinuation of treatment. For some patients orphenadrine may be a drug of abuse.

Excipient Warnings

Orphenadrine Oral Solution 50mg/5ml contains methyl and propyl hydroxybenzoates (preservatives) which may cause allergic reactions (possibly delayed).

The product also contains liquid maltitol and sorbitol solution. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Effects may be enhanced by concomitant administration of anticholinergic drugs. May be provocation of dextropropoxyphene side effects during concurrent administration.

As with other similar agents, the anti-muscarinic effects of orphenadrine may be enhanced by the concomitant administration of other medications with anti-muscarinic properties, such as antihistamines, antispasmodics, tricyclic antidepressants, phenothiazines, dopaminergic anti parkinsonian drugs including amantadine, and anti-arrhythmics such as disopyramide.

Although the additional effects may be minor, there is the potential for the 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.

There is inadequate evidence of safety in human pregnancy, and, although it has been widely used for many years without apparent ill consequence, if considered necessary orphenadrine should be used with caution during pregnancy. Animal studies have not revealed any hazard.

It is probably excreted in milk during lactation. Although the quantity is unlikely to be significant at normal therapeutic doses, if considered necessary orphenadrine should be used with caution during breast feeding.

Orphenadrine may cause blurred vision or slight euphoria. If patients experience these side effects, driving or operating machinery is not recommended.

Common >1/100 <1/10, Uncommon >1/1000 <1/100, Rare >1/10,000 <1/1000

Immune system disorder

Uncommon: Hypersensitivity

Nervous system disorder

Common: Dizziness, restlessness

Uncommon: Sedation, confusion, nervousness, hallucinations, convulsions, insomnia, euphoria, co-ordination disturbances, light-headedness

Rare: Memory disturbances

Eye disorders

Common: Accommodation disorders

Cardiac disorders

Uncommon: Tachycardia

Gastrointestinal disorders

Common: Dry mouth, nausea, gastrointestinal disturbances

Uncommon: Constipation

Renal and urinary disorders

Uncommon: Urinary retention

Incompatible with alkali, protect from light.