The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 14894/0480.
Donepezil Hydrochloride 5 mg & 10 mg Film-coated tablets
Donepezil hydrochloride 5 mg Film-coated tablets
Donepezil hydrochloride 10 mg Film-coated tablets
The medicine will be referred to as Donepezil tablets throughout the remainder of the leaflet
1. What Donepezil tablets are and what they are used for
2. What you need to know before you take Donepezil tablets
3. How to take Donepezil tablets
4. Possible side effects
5. How to store Donepezil tablets
6. Contents of the pack and other information
Donepezil tablets contain the active substance donepezil hydrochloride and belong to a group of medicines called acetylcholinesterase inhibitors.
Donepezil increases the levels of a substance (acetylcholine) in the brain involved in memory function by slowing down the breakdown of acetylcholine.
It is used to treat the symptoms of dementia in people diagnosed as having mild and moderately severe Alzheimer's disease. The symptoms include increasing memory loss, confusion and behavioural changes. As a result, sufferers of Alzheimer's disease find it more and more difficult to carry out their normal daily activities.
Donepezil tablets are for use in adult patients only.
Talk to your doctor or pharmacist before taking Donepezil tablets if you have or have had:
Donepezil tablets are not recommended for use in children and adolescents.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that your doctor has not prescribed for you but which you have bought yourself from a chemist/pharmacist. It also applies to medicines you may take some time in the future if you continue to take Donepezil tablets. This is because these medicines may weaken or strengthen the effects of Donepezil tablets.
In particular it is important to tell your doctor if you are taking any of the following types of medicines:
If you are going to have an operation that requires you to have a general anaesthetic, you should tell your doctor and the anaesthetist that you are taking Donepezil tablets. This is because your medicine may affect the amount of anaesthetic needed.
Tell your doctor or pharmacist the name of your caregiver. Your caregiver will help you to take your medicine as prescribed.
Food will not influence the effect of Donepezil tablets.
Donepezil tablets should not be taken with alcohol because alcohol may reduce its effect.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Donepezil tablets should not be used while breast-feeding.
Alzheimer’s disease may impair your ability to drive or operate machinery and you must not perform these activities unless your doctor tells you that it is safe to do so.
Also, your medicine can cause tiredness, dizziness and muscle cramp. If you experience any of these effects you must not drive or operate machinery.
Donepezil tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains less than 1 mmol sodium (23 mg) per film coated tablet, that is to say essentially ‘sodium-free’.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Initially, the recommended dose is 5 mg of donepezil hydrochloride every night.
If you experience abnormal dreams, nightmares or difficulty in sleeping (see section 4) your doctor may advise you to take donepezil in the morning.
After one month, your doctor may tell you to take 10 mg of donepezil hydrochloride every night.
The tablet strength you will take may change depending on the length of time you have been taking the medicine and on what your doctor recommends. The maximum recommended dose is 10 mg each night.
Always follow your doctor’s or pharmacist’s advice about how and when to take your medicine.
Do not alter the dose yourself without your doctor’s advice.
This medicine is not recommended for use in children and adolescents younger than 18 years of age.
Swallow your Donepezil tablet with a drink of water before you go to bed at night.
Contact your doctor or the nearest hospital emergency department immediately if you take more of the medicine than you should. Take this leaflet and any remaining tablets with you. Overdose symptoms may include feeling and being sick, drooling, sweating, slow heart rate, low blood pressure (light-headedness or dizziness when standing), breathing problems, losing consciousness and seizures (fits) or convulsions.
If you forget to take your medicine, take the next dose at the usual time. Do not take a double dose to make up for a forgotten tablet.
If you forget to take your medicine for more than one week, call your doctor before taking any more medicine.
Do not stop taking the tablets unless told to do so by your doctor. If you stop taking Donepezil hydrochloride tablets, the benefits of your treatment will gradually fade away.
Your doctor or pharmacist will advise you on how long you should continue to take your tablets. You will need to see your doctor from time to time to review your treatment and assess your symptoms.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported by people taking Donepezil tablets.
Tell your doctor if you have any of these effects while you are taking Donepezil tablet(s)
You must tell your doctor immediately if you notice these serious side effects mentioned. You may need urgent medical treatment.
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1000 people):
Very rare (may affect up to 1 in 10,000 people):
Not known (frequency cannot be estimated from available data)
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Not known (frequency cannot be estimated from available data)
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is donepezil hydrochloride:
Each tablet contains 5 mg donepezil hydrochloride, equivalent to 4.56 mg of donepezil.
Each tablet contains 10 mg donepezil hydrochloride, equivalent to 9.12 mg donepezil.
The other ingredients are:
Core- Lactose monohydrate, Maize starch, Hydroxypropyl cellulose, Microcrystalline cellulose, Sodium starch glycolate (type A), Magnesium stearate.
Coating- Opadry yellow contains Hypromellose 5cP (E464), Titanium dioxide (E171), Macrogol 400, Talc, Iron Oxide Yellow (E172)
Donepezil hydrochloride 5 mg Film-coated tablets are yellow coloured, circular, biconvex film-coated tablets debossed with ‘RC25’ on one side
Donepezil hydrochloride 10 mg Film-coated tablets are yellow coloured, capsule shaped film-coated tablets debossed with ‘RC’ & ‘26’ on either side of the score line.
The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Product is available in blister packs of:
5 mg: 7, 28, 30, 56, 98, and 100 film-coated tablets
10 mg: 28, 30, 56, 98, and 100 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
This leaflet was last revised in October 2022.