Abbreviated Prescribing Information: Trihexyphenidyl hydrochloride 5mg/5ml Syrup. Consult Summary of Product Characteristics before prescribing. Presentation: a blackcurrant scented and flavoured colourless syrup with each 5ml containing 5mg trihexyphenidyl hydrochloride. Therapeutic Indications: Parkinsonism and drug induced extrapyramidal syndrome. Posology and Method of Administration: Adults and Elderly: Initial dose is administered at 2mg and subsequent doses up to 20 mg as recommended by a physician. Oral method of administration. Paediatric population: Not recommended. Contra-indications: Hypersensitivity to the active substance or to any of the excipients.
Special Warnings and Precautions for use: Trihexyphenidyl may require long-term use, so patients should be closely monitored, and the drug should be administered cautiously to avoid allergic or untoward reactions. Abrupt discontinuation should be avoided except in case of vital complications. Incipient glaucoma may be precipitated. Trihexyphenidyl is not contraindicated in hypertension, cardiac, liver or kidney disorders but requires close monitoring. As trihexyphenidyl may exacerbate or provoke tardive dyskinesia, it is not recommended for use in patients with this condition. Trihexyphenidyl may aggravate myasthenia gravis and should therefore be avoided or administered with extreme caution in affected patients. Although certain psychiatric effects like confusion, delusions, and hallucinations, all of which may occur with any atropine-like drugs, have been rarely reported with trihexyphenidyl, it should be used with extreme caution in elderly patients. Trihexyphenidyl may be the subject of abuse if given in sufficient amounts due to its hallucinogenic and euphoriant properties. Excipient warning: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not be administered trihexyphenidyl. Propylene glycol: co-administration with any substrate for alcohol dehydrogenase such as ethanol may induce adverse effects in children less than 5 years old. Propylene glycol may reach foetus and was found in milk and hence administration of propylene glycol to pregnant or lactating patients should be considered on a case by case basis. Patients with impaired kidney or hepatic function require medical monitoring due to reported adverse events linked to the excipient propylene glycol, including renal dysfunction (acute tubular necrosis), acute renal failure, and liver dysfunction. Any warning from the MC, CHM, CSM or MHRA: No. Black Triangle notice: Not applicable. : dryness of mouth, constipation, blurring of vision, dizziness, mild nausea, nervousness, hypersensitivity, restlessness, confusional states, agitation, delusions, hallucinations, insomnia-especially in elderly and arteriosclerosis patients, euphoria, impairment of immediate and short-term memory function, worsening of myasthenia gravis, dilatation of pupils with loss of accommodation, photophobia, raised intraocular pressure, tachycardia, decreased bronchial secretions, difficulty in swallowing, vomiting, flushing, dryness of skin, skin rashes, urinary retention, difficulty in micturition, thirst and pyrexia. Refer to the SmPC for full details of adverse reactions. Legal Category: Prescription only medicine. Pack Size and NHS Price: 200 ml – £112.78. Marketing Authorisation Number: PL 00427/0222 Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: Sep-2025


