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Donepezil Oral Solution Abbreviated Prescribing Information

Abbreviated Prescribing Information: Donepezil 1mg/ml oral solution Consult Summary of Product Characteristics before prescribingPresentation: Clear, colourless liquid with a strawberry odour containing 1mg/ml donepezil hydrochloride. Therapeutic Indications: Symptomatic treatment of mild to moderately severe Alzheimer’s dementia. Posology and Method of Administration: Adults/Elderly: Initiate at 5mg/day in the evening and maintain for at least one month after which dose may be increased to the maximum recommended dose of 10mg/day. For oral use. A similar dose schedule can be followed for patients with renal impairment, but in patients with mild to moderate hepatic impairment, due to possible increased exposure, dose escalation should be performed according to individual tolerability. Paediatric population: Donepezil is not recommended. Contraindications: Hypersensitivity to donepezil hydrochloride or piperidine derivatives, hereditary fructose intolerance, hypersensitivity to metabisulphites or other excipients. Special Warnings and Precautions for use: Use in severe Alzheimer’s dementia, other types of dementia or other types of memory impairment, has not been investigated. The product contains sorbitol, so patients with rare hereditary problems of fructose intolerance should not take this medicine. Sodium metabisulphite may rarely cause hypersensitivity reactions and bronchospasm. Methyl parahydroxybenzoate may cause allergic reactions. Donepezil is likely to exaggerate succinylcholine-type muscle relaxation during anaesthesia. Cholinesterase inhibitors may have vagotonic effects on heart rate, potentially particularly important to patients with “sick sinus syndrome” or other supraventricular cardiac conduction conditions. There have been reports of syncope and seizures. Consider the possibility of heart block or long sinusal pauses in such patients. Caution is advised in patients with pre-existing or family history of QTc prolongation, in patients treated with drugs affecting the QTc interval, or in patients with relevant pre-existing cardiac disease or electrolyte disturbances. Patients at increased risk for developing ulcers should be monitored for symptoms. Potential for bladder outflow obstruction. Could cause generalised convulsions although may also be a manifestation of Alzheimer’s disease. May exacerbate or induce extrapyramidal symptoms. Neuroleptic Malignant Syndrome can occur very rarely in association with donepezil, particularly in patients also receiving concomitant antipsychotics. Prescribe with care to patients with a history of asthma or obstructive pulmonary disease. Avoid concomitant administration of other inhibitors of acetylcholinesterase, agonists or antagonists of the cholinergic system. Any warning from the MC, CHM CSM or MHRA. No. Black Triangle notice (if relevant): N/A. Legal Category: POM. The reported adverse reactions are: Very common: diarrhoea, nausea, and headache. Common: common cold, anorexia, hallucinations, agitation, aggressive behaviour, abnormal dreams and nightmares, syncope, dizziness, insomnia, vomiting, abdominal disturbance, rash, pruritis, muscle cramps, urinary incontinence, fatigue, pain, accident including falls. Uncommon: seizure, bradycardia, gastrointestinal haemorrhage, gastric and duodenal ulcers, salivary hypersecretion, minor increase in serum concentration of muscle creatine kinase. Rare: Extrapyramidal symptoms, sino-atrial block, atrioventricular block, liver dysfunction including hepatitis. Very rare: neuroleptic malignant syndrome, rhabdomyolysis. Not known: Libido increased, Hypersexuality, Pleurothotonus (Pisa syndrome), Polymorphic ventricular tachycardia including Torsade de Pointes; Electrocardiogram QT interval prolonged. Pack Size and NHS Price: Donepezil Hydrochloride is available as 150ml or 2 x 150ml. – 150ml £114.07. Marketing Authorisation Number: PL 00427/0223. Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: July 2024.

Adverse Drug Events

Information about adverse event reporting can be found at www.mhra.gov.uk/yellowcard
Adverse events should also be reported to Rosemont Pharmaceuticals Ltd on 0113 244 1400