This site is intended for UK healthcare professionals
Medscape UK Univadis Logo
Medscape UK Univadis Logo

Donepezil hydrochloride oral

Updated 2 Feb 2023 | Anticholinesterases


Oral formulations containing donepezil

Drugs List

  • ARICEPT 10mg tablets
  • ARICEPT 5mg tablets
  • ARICEPT EVESS 10mg orodispersible tablet
  • ARICEPT EVESS 5mg orodispersible tablet
  • donepezil 10mg orodispersible tablets sugar-free
  • donepezil 10mg tablets
  • donepezil 1mg/ml oral solution sugar-free
  • donepezil 5mg orodispersible tablets sugar-free
  • donepezil 5mg tablets
  • Therapeutic Indications


    Mild - moderate dementia in Alzheimer's disease



    Treatment is initiated at 5 mg once daily in the evening.

    The 5 mg dose should be maintained for at least one month in order to allow the earliest clinical response to treatment to be assessed and to allow steady-state concentrations of donepezil hydrochloride to be achieved.

    Following a one-month clinical assessment of treatment at 5 mg, the dose may be increased to 10 mg once daily. The maximum recommended daily dose is 10 mg. Doses greater than 10 mg have not been studied in clinical trials.

    Maintenance therapy may be continued for as long as a therapeutic benefit to the patient exists. Regular patient monitoring is recommended to assess the clinical benefit of therapy with donepezil hydrochloride.

    Upon discontinuation of treatment, a gradual abatement of the beneficial effects of donepezil is seen.


    Children under 18 years
    Long QT syndrome
    Torsade de pointes

    Precautions and Warnings

    Family history of long QT syndrome
    Predisposition to gastrointestinal ulceration
    Electrolyte imbalance
    Glucose-galactose malabsorption syndrome
    Hepatic impairment
    Hereditary fructose intolerance
    History of asthma
    History of gastrointestinal ulceration
    History of obstructive pulmonary disease
    History of torsade de pointes
    Lactose intolerance
    Non-paced sinus node dysfunction
    Sinoatrial exit block
    Supraventricular cardiac conduction disorder

    Correct electrolyte disorders before treatment
    Advise ability to drive/operate machinery may be affected by side effects
    Do not start treatment unless a carer is available to monitor drug intake
    Treatment to be initiated and supervised by a specialist
    Contains sodium metabisulfite. Caution,may cause allergic reactions
    Oral liquid contains hydroxybenzoate: caution in hypersensitivity
    Oral solution contains sodium metabisulfite: May cause allergic reaction
    Presentations with sorbitol unsuitable in hereditary fructose intolerance
    Some formulations contain lactose
    Monitor cardiac function before and regularly during treatment
    Perform ECG before and during treatment
    Monitor for syncope and bradycardia
    Monitor patients for signs and symptoms of Neuroleptic Malignant Syndrome
    Monitor serum electrolytes
    Patients on prolonged therapy should be regularly reviewed
    When used with neuroleptics, risk of neuroleptic malignant syndrome
    May cause convulsions
    May cause or exacerbate extrapyramidal symptoms
    Predisposition QT prolongation: Counsel patient on symptoms of arrhythmias
    Discontinue if patient develops neuroleptic malignant syndrome
    Discontinue if significant/persistent hepatic function abnormalities occur

    Pregnancy and Lactation


    Donepezil hydrochloride is contraindicated during pregnancy.

    There are no adequate or well-controlled studies in pregnant women. The potential risk for humans is unknown.

    Teratology studies conducted in pregnant rats at doses up to approximately 13 times the maximum recommended human dose and in pregnant rabbits at doses up to approximately 16 times the maximum recommended human dose did not disclose any evidence for a teratogenic potential. However, in a study in which pregnant rats were given approximately 8 times the maximum recommended human dose from day 17 of gestation through to day 20 postpartum, there was a slight increase in stillbirths and a slight decrease in pup survival through day 4 postpartum at this dose. No effect was observed at the next lower dose tested (Briggs, 2011).

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Donepezil hydrochloride is contraindicated in breastfeeding.

    It is not known whether donepezil is excreted in human breast milk and there are no studies in lactating women. However, donepezil is known to be excreted in the milk of rats.

    Due to its long half-life, and its ability to affect cholinergic function in all mammals, some caution is recommended in breastfeeding women until data is available.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Side Effects

    Abdominal disorders
    Accidental injury
    Atrioventricular block
    Bladder outflow obstruction
    Common cold
    Creatine kinase increased
    Dream abnormalities
    Duodenal ulcer
    Extrapyramidal effects
    Gastric ulceration
    Gastro-intestinal haemorrhage
    Hepatic impairment
    Muscular cramps
    Neuroleptic malignant syndrome
    Prolongation of QT interval
    Sino-atrial block
    Urinary incontinence


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: July 2014

    Reference Sources

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia. Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press Accessed on July 17, 2014.

    Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.

    Summary of Product Characteristics: Aricept tablets. Eisai Ltd. Revised November 2016.

    Summary of Product Characteristics: Aricept Evess tablets. Eisai Ltd. Revised January 2013.

    Summary of Product Characteristics: Donepezil hydrochloride 1mg/1ml oral solution. Rosemont Pharmaceuticals Limited. Revised January 2014.

    Access the full UK drug database with a FREE Medscape UK Account
    It takes just a few minutes, and you’ll get unlimited access to information on over 11,000 UK drugs.
    Register for Free

    Already a member? Log in

    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

    FDB Logo

    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.