KEMADRIN

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

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 After a period of 3 to 4 months of therapy, Kemadrin should be withdrawn and the patient observed to see whether the neuroleptic-induced extra-pyramidal symptoms recur.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.

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.

For this preparation there is no modern clinical documentation which can be used as support for determining the frequency of adverse reactions. Uncommon (≥1/1000 and <1/100) Agitation, anxiety, nervousness, confusion, disorientation, hallucinations Psychiatric disorders Rare (<1/1000) Psychotic disorder Nervous system disorders Uncommon (≥1/1000 and <1/100) Dizziness, memory impairment, impaired cognition Eye disorders Common (≥ 1/100) Blurred vision Common (≥ 1/100) Dry mouth, constipationGastrointestinal disorders Uncommon (≥1/1000 and <1/100) Nausea, vomiting, gingivitis Skin and subcutaneous tissue disorder Uncommon (≥1/1000 and <1/100) Rash Renal and urinary disorders Common (≥1/100) Urinary retention The main undesirable effects are those to be expected from any anticholinergic agent – these are generally reversible on reducing the dosage.

With high doses of procyclidine dizziness, mental confusion, impaired cognition and memory, disorientation, anxiety, agitation and hallucinations may occur. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard

As with all anticholinergics the benefit/risk ratio should be assessed when prescribing Kemadrin in patients with existing angle-closure (narrow angle) glaucoma or those considered to be predisposed to glaucoma. Cautious prescribing is also indicated in patients predisposed to obstructive disease of the gastro-intestinal tract and those with urinary symptoms associated with prostatic hypertrophy.

In a proportion of patients undergoing neuroleptic treatment, tardive dysknesias will occur. While anticholinergic agents do not cause this syndrome, when given in combination with neuroleptics they may exacerbate the symptoms of tardive dyskinesia or reduce the threshold at which these symptoms appear in predisposed patients.

In such individuals subsequent adjustment of neuroleptic therapy or reduction in anticholinergic treatment should be considered. Patients with mental disorders occasionally experience a precipitation of a psychotic episode when procyclidine is administered for the treatment of the extrapyramidal side effects of neuroleptics.

8). Specifically, the elderly patient may be particularly vulnerable to Central Nervous System disturbances such as confusion, impairment of cognitive function and memory, disorientation and hallucinations. These effects are usually reversible on reduction or discontinuation of anticholinergic therapy.

There is no specific information available concerning the use of procyclidine hydrochloride in patients with impaired renal or hepatic function. However, since procyclidine is metabolised in the liver and excreted via the urine care should be exercised when administering procyclidine to patients with impairment of renal or hepatic function.

Kemadrin should not be withdrawn abruptly as rebound parkinsonian symptoms may occur. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Kemadrin is contra-indicated in individuals with known hypersensitivity to any component of the preparation, untreated urinary retention, closed angle glaucoma and gastro-intestinal obstruction.