PROCYCLIDINE

Posology The variation in optimum dosage from one patient to another should be taken into consideration by the physician. 5mg three times daily after meals. 5 – 5mg daily at intervals of two to three days, until optimum clinical response is reached.

Usual maximum daily dose is 20 – 30mg but occasionally 60mg may be required. 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.

Procyclidine may be combined with levodopa or amantadine in patients who are inadequately controlled on a single agent. When used for the control of neuroleptic-induced extra-pyramidal symptoms the dose should not exceed 20mg daily.

Treatment should be stopped after 3-4 months to see if these symptoms recur. Periodic cessation of treatment is to be recommended even in patients who appear to require longer term treatment. Use in Children Not recommended. Use in the Elderly A reduced dose may be required as elderly patients are more sensitive to anticholinergics.

Method of administration For oral use. The tablets may be better tolerated if taken with a meal.

Frequencies displayed use the following convention:

Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated form the available data). Immune system disorders Not known hypersensitivity Psychiatric disorders Uncommon ( ≥1/1000 and <1/100) Agitation, anxiety, nervousness, confusion, disorientation, hallucinations 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 Cardiac disorders Not known tachycardia 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, excitement, impaired cognition and memory, disorientation, anxiety, agitation, insomnia 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

As with all anticholinergics the benefit/risk ratio should be assessed when prescribing procyclidine in patients with existing angle-closure (narrow angle) glaucoma or those considered to be predisposed to glaucoma. Also use with caution in patients with obstructive disease of the gastrointestinal tract, cardiac disorders, cardiovascular disease, hepatic and renal impairment, and those with urinary symptoms associated with prostatic hypertrophy.

In a proportion of patients undergoing neuroleptic treatment, tardive dyskinesias 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.

Elderly patients, especially those on high doses of anticholinergics may be more susceptible to the adverse events associated with such therapy. Specifically, the elderly patient may be 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. Caution: procyclidine may be liable to abuse; it may produce a euphoric effect.

Procyclidine Tablets are contra-indicated in untreated urinary retention, closed angle glaucoma, gastrointestinal obstruction, prostatic hypertrophy or in patients with known hypersensitivity to any of the ingredients.