DISIPAL TABLETS

Tablet

Anti-cholinergic, for the treatment of all forms of Parkinsonism, including drug-induced extrapyramidal symptoms (neuroleptic syndrome).

For Adults, and the Elderly:

Initially 150 mg daily in divided doses, increasing by 50 mg every two or three days until maximum benefit is obtained. Optimal dosage is usually 250 - 300 mg daily in divided doses in idiopathic and post-encephalitic Parkinsonism, 100 - 300 mg daily in divided doses in the neuroleptic syndrome. Maximal dosage, 400 mg daily in divided doses. The elderly may be more susceptible to side-effects at doses which are clinically optimal.

For children:

A dosage for children has not been established.

Contraindicated in patients with tardive dyskinesia, glaucoma, or prostatic hypertrophy, untreated urinary retention, gastro-intestinal obstruction, porphyria.

Hypersensitivity to the active substance or to any of the excipients.

Use with caution in patients with micturition difficulties, in pregnancy and breast feeding, and in the presence of cardiovascular disease and hepatic or renal impairment. Use in caution in the elderly (see 4.2). Avoid abrupt discontinuation of treatment. For some patients, orphenadrine may be a drug of abuse.

Patients with rare hereditary problems of fructose and galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

The colours sunset yellow (E110), tartrazine (E102) and amaranth (E123) may cause allergic reactions.

Concomitant use of other antimuscarinic drugs can lead to an increase in side effects such as dry mouth and urine retention.

No recommendations; if considered necessary, it should be used with caution, see 4.4.

Patients must be advised to exercise caution while driving or operating machinery or whilst carrying out other skilled tasks.

Toxic effects are anti-cholinergic in nature and the treatment is gastric lavage, cholinergics such as carbachol, anticholinesterases such as physostigmine, and general non-specific treatment.

Orphenadrine, which is a congener of diphenhydramine without sharing its soporific effect, is an antimuscarinic agent. It also has weak antihistaminic and local anaesthetic properties.

Orphenadrine is used as the hydrochloride in the symptomatic treatment of Parkinsonism. It is also used to alleviate the extrapyramidal syndrome induced by drugs such as the phenothiazine derivatives, but is of no value in tardive dyskinesia, which may be exacerbated.

Orphenadrine is readily absorbed from the gastro-intestinal tract, and very readily absorbed following intramuscular injection. It is rapidly distributed in tissues and most of a dose is metabolised and excreted in the urine along with a small proportion of unchanged drug. A half life of 14 hours has been reported.

No relevant pre-clinical safety data has been generated

Lactose

Sucrose

Acacia

Maize starch

Tribasic calcium phosphate

Stearic acid

Magnesium stearate

Opaseal P-17-0200 (containing IMS, polyvinylacetate phthalate and stearic acid)

Calcium carbonate

Talc

Kaolin

Titanium dioxide

Gelatin

Opalux yellow AS 3026 (containing sucrose, titanium dioxide, tartrazine E102, sunset yellow E110, povidone, amaranth E123 and sodium benzoate E211)

Opaglos 6000 (containing ethanol, shellac, beeswax and yellow carnuba wax)

None

Three years

Store at room temperature (15°C - 25°C)

Amber glass click-lock bottles and/or securitainers and/or plastic lid-seal containers, containing 100, 250, 1,000, or 10,000 tablets.

None

Astellas Pharma Ltd.

3^rd Floor

Future House

The Glanty

Egham

Surrey

TW20 9AH

United Kingdom

PL 0166/5001R

6 May 1987; renewed March 2003.

2^nd March 2012

POM