KEMADRIN Tablet Ref.[9751] Active ingredients:

The variation in optimum dosage from one patient to another should be taken into consideration by the physician.

Dosage in adults

Parkinson’s disease

Treatment is usually started at 2.5 mg procyclidine three times per day, increasing by 2.5 to 5 mg per day at intervals of two or three days until the optimum clinical response is achieved.

The usual maintenance dose to achieve optimal response is 15 to 30 mg procyclidine per day.

Addition of a fourth dose before retiring has been seen to be beneficial in some patients. Doses up to 60 mg procyclidine have been well tolerated, and at the discretion of the attending physician dosing to this level may be appropriate.

In general younger patients or those with postencephalitic parkinsonism may require higher doses for a therapeutic response than older patients and those with arteriosclerotic parkinsonism.

Kemadrin may be combined with levodopa or amantadine in patients who are inadequately controlled on a single agent.

Neuroleptic-induced extrapyramidal symptoms

Treatment is usually initiated at 2.5 mg procyclidine three times per day increasing by 2.5 mg daily until symptoms are relieved.

The effective maintenance dose is usually 10 to 30mg procyclidine per day. After a period of 3 to 4 months of therapy, Kemadrin should be withdrawn and the patient observed to see whether the neuroleptic-induced extra-pyramidal symptoms recur.

If this is the case Kemadrin should be reintroduced to avoid debilitating extra-pyramidal symptoms. Cessation of treatment periodically is to be recommended even in patients who appear to require the drug for longer periods.

Paediatric population

The use of Kemadrin in this age group is not recommended.

Older people

Elderly patients may be more susceptible than younger adults to the anticholinergic effects of Kemadrin and a reduced dosage may be required (see section 4.4).

Method of administration

Pharmacokinetic studies have indicated that the mean plasma elimination half-life of Kemadrin is sufficient to allow twice daily administration orally, if more convenient.

Oral administration may be better tolerated if associated with a meal.

Tablets can be divided into equal doses.

Symptoms and signs

Symptoms of overdosage include stimulant effects such as agitation, restlessness and confusion with severe sleeplessness lasting up to 24 hours or more. Visual and auditory hallucinations have been reported. Most subjects are euphoric but the occasional patient may be anxious and aggressive. The pupils are widely dilated and unreactive to light. In recorded cases, the disorientation has lasted 1 to 4 days and ended in a recuperative sleep. Signs of CNS depression including somnolence, reduced consciousness, and occasionally coma have been reported usually following very large overdoses.

Tachycardia has also been reported in association with cases of Kemadrin overdose.

Treatment

If procyclidine has been ingested within the previous hour or two (or possibly longer in view of its likely effects on gastric motility) then activated charcoal should be used to reduce absorption. Gastric lavage should only be considered if clinically appropriate. Other active measures such as the use of cholinergic agents or haemodialysis are extremely unlikely to be of clinical value although if convulsions occur they should be controlled by injections of diazepam.

5 years.

Do not store above 25°C.

Amber glass bottles with low density polyethylene snap fit closures. Pack sizes 50, 100.

Polypropylene containers with polyethylene snap-fit lids. Pack size 500.

Round enamelled tins with lever lids. Pack size 5,000.

See section 4.2 posology and method of administration.