ORPHENADRINE HYDROCHLORIDE

Adults and the elderly:

Initially, 150mg daily in divided doses, increasing by 50mg every two or three days until maximum benefit is obtained. Optimal dosage is usually 250mg to 300mg daily in divided doses in idiopathic and post-encephalitic Parkinsonism; 100mg to 150mg daily in divided doses in arteriosclerotic parkinsonism; and 150mg to 300mg daily in divided doses in the neuroleptic syndrome.

Maximal dosage is 400mg daily in divided doses. The elderly may be more susceptible to side effects at doses which are clinically optimal.

Children:

Not recommended for use in children.

System Organ Class Common >1/100 <1/10 Uncommon >1/1000 <1/100 Rare >1/10,000 <1/1000 Immune system disorder Hypersensitivity Nervous system disorder Dizziness, restlessness Sedation, confusion, nervousness, hallucinations, convulsions, insomnia, euphoria, co-ordination disturbances, light-headedness Memory disturbances Eye disorders Accommodation disorders Cardiac disorders Tachycardia Gastrointestinal disorders Dry mouth, nausea, gastrointestinal disturbances Constipation Renal and urinary disorders Urinary retention

2). When used alone or with analgesics, pain or skeletal muscle spasms have been reported. Use with caution in conditions characterised by tachycardia. 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. May cause allergic reactions (possibly delayed).

Liquid Maltitol (E965) 2049mg in each 5ml. Patients with rare hereditary problems of fructose intolerance should not take this medicine. May have a mild laxative effect. 7 kcal/5ml • Benzyl Alcohol. 03mg of benzyl alcohol in each 5 ml.

Benzyl alcohol may cause allergic reactions. High volumes should be used with caution and only if necessary, especially in subjects with liver or kidney impairment because of the risk of accumulation and toxicity (metabolic acidosis).

7mg in each 5ml. The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account. The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly.

Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product. 7mg in each 5 ml. The amount in 5 ml of this medicine is equivalent to less than 1 ml beer or 1 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects.

Hypersensitivity to orphenadrine or to any of the excipients. In patients with prostatic hypertrophy, tardive dyskinesia, porphyria, urinary retention and must also be used with caution in elderly men. Also in patients with paralytic ileus or pyloric stenosis, where use may lead to obstruction.

Do not use in patients with glaucoma or too narrow an angle between iris and cornea, as it may raise intra-ocular pressure. Not indicated for use in patients at risk of developing hyperpyrexia.