Procyclidine Hydrochloride Abbreviated Prescribing Information

Abbreviated Prescribing Information: Procyclidine Hydrochloride 2.5mg/5ml and 5mg/5ml oral solution. Consult Summary of Product Characteristics before prescribing. Presentation: An oral solution containing 2.5mg or 5mg of procyclidine hydrochloride per 5ml. Increase by 2.5–5mg daily at intervals of two to three days until the optimum clinical response is achieved. Therapeutic Indications: Procyclidine is indicated in all forms of Parkinson’s disease: idiopathic (paralysis agitans), postencephalitic and arteriosclerotic. It is also used to control troublesome extrapyramidal symptoms induced by neuroleptic drugs including pseudo parkinsonism, acute dystonic reactions and akathisia. Posology and Method of Administration: For oral use only. Adults: Initially 2.5mg three times a day, increasing to a maximum of 30mg or occasionally as high as 60mg (at the discretion of the attending physician where appropriate). For neuroleptic-induced extrapyramidal symptoms usually not more than 20mg daily for 3-4 months after which treatment should be discontinued to determine whether symptoms recur. Cessation of treatment periodically is recommended. Avoid abrupt discontinuation. Procyclidine may be combined with levodopa or amantadine in patients who are inadequately controlled on a single agent. Elderly: Reduced dose may be required. Paediatric population: Not recommended. Contra-indications: Known hypersensitivity to any component of the preparation, untreated urinary retention, closed angle glaucoma, and gastro-intestinal obstruction. Pregnancy and Lactation: Use during pregnancy and lactation only if the expected benefit outweighs any possible risk. Safety not established. Special Warnings and Precautions for use: Contains benzyl alcohol, ethanol, liquid maltitol, methyl and propyl parahydroxybenzoates, and propylene glycol. See SmPC for excipient-specific warning. Caution should be exercised in patients pre-disposed to glaucoma or with existing angle-closure glaucoma, obstructive disease of the gastro-intestinal tract and those with urinary symptoms associated with prostatic hypertrophy. Tardive dyskinesias may occur when given in combination with neuroleptics. Subsequent adjustment of neuroleptic therapy or reduction in anti-cholinergic 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 and 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. Care should be exercised when administering procyclidine to patients with impairment of renal or hepatic function. Procyclidine should not be withdrawn abruptly as rebound parkinsonian symptoms may occur. Procyclidine has the potential for abuse and should be prescribed with caution. Any warning from the MC, CHM CSM or MHRA: No Black Triangle notice (if relevant) Not applicable. A list of adverse reactions Most commonly recorded: dry mouth, blurring of vision, urinary retention and constipation. At higher doses, dizziness, mental confusion, impaired cognition and memory, disorientation, anxiety, agitation and hallucinations may occur. Rarely, the development of psychotic-like symptoms have been reported in association with procyclidine. Consult the SPC for full details of adverse reactions. Pack Size and NHS Price: 2.5mg/5ml – 150ml £48.72 5mg/5ml – 150ml £72.12. Marketing Authorisation Number: 2.5mg/5ml (PL 00427/0082) and 5mg/5ml (PL 00427/0083). Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Legal Category: Prescription only medicine. Date of Preparation: [November-2025]