PROCYCLIDINE

The dosage must be determined according to the needs of individual patients. 5 mg per day until symptomatic relief is obtained without side-effects, usually between 20 mg and 30 mg daily. The daily dose should be in 3 or 4 divided doses and taken after meals.

Daily doses of up to 60 mg have occasionally been required. Arteriosclerotic patients generally require less than post-encephalitic patients. In some patients who cannot tolerate a too rapid increase in dosage it is advisable to make the increase at longer intervals.

Procyclidine may be combined with levodopa or amantadine in patients who are inadequately controlled on a single agent. 5 mg three times daily, increasing to the optimum daily dosage which is usually 10 mg to 20 mg in divided doses.

After 3 to 4 months (and periodically thereafter, in long-term therapy), treatment should be stopped and the patient observed for recurrence of the symptoms. Abrupt cessation of treatment must be avoided. 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.

Elderly:

The elderly are more sensitive to anticholinergics and a reduced dose may be required.

Paediatric population:

Not recommended. Method of administration For oral use. The tablets may be better tolerated if taken with a meal.

Adverse reactions are listed by estimated frequency: common (>1/100, <1/10); uncommon (>1/1,000, <1/100); rare (>1/10,000, <1/1,000); very rare (<1/10,000), not known (cannot be estimated form the available data). The most commonly reported side effects are those due to the anticholinergic properties of procyclidine, and are generally reversible on reduction of dosage.

With high doses of Procyclidine dizziness, mental confusion, excitement, impaired cognition and memory, disorientation, anxiety, agitation, insomnia and hallucinations may occur. 4). 4).

Nervous system disorders Uncommon:

Dizziness, impaired cognition, memory impairment, especially at higher doses and in the elderly. 4) Eye disorders Common: Blurred vision Gastrointestinal disorders Common: Dry mouth, constipation Uncommon: Nausea, vomiting, gingivitis Skin and subcutaneous disorders Uncommon: Rash Renal and urinary disorders Common: Urinary retention Cardiac disorders: Not known: tachycardia Immune system disorders: Not known: hypersensitivity 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 such as procyclidine, cautious prescribing is indicated in patients with existing angle-closure glaucoma or those considered to be predisposed to glaucoma. Caution is also required in patients predisposed to obstructive disease of the gastro-intestinal tract, those with urinary symptoms associated with prostatic hypertrophy cardiac disorders, cardiovascular disease, hepatic and renal impairment.

In a proportion of patients undergoing neuroleptic treatment, tardive dyskinesias will occur. While anticholinergics 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 anticholinergics 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 extra-pyramidal 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 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 patient with impaired renal or hepatic function.

However, since procyclidine is metabolized in the liver and excreted via the urine, care should be exercised when administering procyclidine to patients with impairment of renal or hepatic function. Procyclidine tablets should not be withdrawn abruptly as rebound Parkinsonism symptoms may occur.

Procyclidine is contra-indicated in patients with known sensitivity to the ingredients in the tablet and those with the following conditions: • Untreated urinary retention • Angle closure (narrow angle) glaucoma • Gastro intestinal obstruction • prostatic hypertrophy or in patients with known hypersensitivity to any of the ingredients