MUSCINIL, PROCYCLIDINE

The dosage must be determined according to the needs of individual patients. 5 – 5 mg per day at intervals of two to three days, 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.

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.

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). The most commonly reported side effects are those due to the anticholinergic properties of procyclidine, and are generally reversible on reduction of dosage.

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 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. 1 Pharmacodynamic properties Pharmacotherapeutic group: Anticholinergic agents; tertiary amines ATC Code: N04AA04 Procyclidine is a synthetic anticholinergic agent that blocks the excitatory effects of acetylcholine at the muscarinic receptor.

Idiopathic Parkinson’s disease is thought to result from degeneration of neurones in the substantia nigra whose axons project and inhibit cells in the corpus striatum. Blockade by neuroleptic drugs of the dopamine released by these terminals produces a similar clinical picture.

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 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. Caution: procyclidine may be liable to abuse; it may produce a euphoric effect.

1. Procyclidine is also contra-indicated in patients with the following conditions: • Untreated urinary retention • Angle-closure (narrow angle) glaucoma • Gastro-intestinal obstruction • Prostatic hypertrophy