Patient leaflet - Donepezil 5 mg orodispersible tablets
1. What Donepezil is and what it is used for
Donepezil contains the active substance donepezil hydrochloride. Donepezil (donepezil hydrochloride) belongs 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 is for use in adult patients only.
2. What you need to know before you use Donepezil
Do not take Donepezil
if you are allergic to donepezil hydrochloride, or to piperidine derivatives, or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Donepezil if you have or have had:
- stomach or duodenal ulcers
- seizures (fits) or convulsions
- a heart condition (such as irregular or very slow heart beat, heart failure, myocardial infarction)
- a heart condition called ‘prolonged QT interval’ or a history of certain abnormal heart rhythms called Torsade de Pointes or if anyone in your family has ‘prolonged QT interval’
- low levels of magnesium or potassium in your blood
- asthma or other long term lung disease
- liver problems or hepatitis
- difficulty passing urine or mild kidney disease
Also tell your doctor if you are pregnant or think you might be pregnant.
Children and adolescents
Donepezil is not recommended for use in children and adolescents (younger than 18 years of age).
Other medicines and Donepezil
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. This is because these medicines may weaken or strengthen the effects of Donepezil.
In particular it is important to tell your doctor if you are taking any of the following types of medicines:
- medicines for heart rhythm problems e.g. amiodarone, sotalol
- medicines for depression e.g. citalopram, escitalopram, amitriptyline, fluoxetine
- medicines for psychosis e.g. pimozide, sertindole, ziprasidone
- medicines for bacterial infections e.g. clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
- anti-fungal medicines e.g. ketoconazole
- other Alzheimer’s disease medicines, e.g. galantamine
- pain killers or treatment for arthritis e.g. aspirin, non-steroidal anti-inflammatory (NSAID) drugs such as ibuprofen, or diclofenac sodium
- anticholinergic medicines, e.g. tolterodine
- anticonvulsants e.g. phenytoin, carbamazepine
- medication for a heart condition e.g. quinidine, beta-blockers (propranolol and atenolol)
- muscle relaxants e.g. diazepam, succinylcholine
- general anaesthetic
- medicines obtained without a prescription e.g. herbal remedies
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. This is because your medicine may affect the amount of anaesthetic needed.
Donepezil can be used in patients with kidney disease or mild to moderate liver disease. Tell your doctor first if you have kidney or liver disease. Patients with severe liver disease should not take Donepezil.
Tell your doctor or pharmacist the name of your caregiver. Your caregiver will help you to take your medicine as it is prescribed.
Donepezil with food, drink and alcohol
Food will not influence the effect of Donepezil.
Donepezil should not be taken with alcohol because alcohol may change its effect.
Pregnancy, breast-feeding and fertility
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 any medicine.
Donepezil should not be used while breast-feeding.
Driving and using machines
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.
3. How to use Donepezil
How much Donepezil should you take
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 (one white tablet) every night before you go to bed. After one month, your doctor may tell you to take 10 mg (one yellow tablet) every night before you go to bed.
If you experience abnormal dreams, nightmares or difficulty in sleeping (see section 4) your doctor may advise you to take Donepezil in the morning.
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 or pharmacist’s advice about how and when to take your medicine. Do not alter the dose yourself without your doctor’s advice.
How to take your medicine
The tablet should be placed on your tongue and allowed to disintegrate before swallowing, with or without water, according to your preference.
Use in Children and adolescents
Donepezil is not recommended for use in children and adolescents (younger than 18 years of age).
If you take more Donepezil than you should
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 nausea (feeling sick) and vomiting (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 Donepezil
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
If you stop taking Donepezil
Do not stop taking the tablets unless told to do so by your doctor. If you stop taking Donepezil, the benefits of your treatment will gradually fade away.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
For how long should you take Donepezil
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.
4. Possible side effects
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.
Tell your doctor if you have any of these effects while you are taking Donepezil.
Serious side effects:
You must tell your doctor immediately if you notice these serious side effects mentioned. You may need urgent medical treatment.
- liver damage e.g. hepatitis. The symptoms of hepatitis are nausea (feeling sick) or vomiting (being sick), loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes, and dark coloured urine (may affect up to 1 in 1,000 people)
- stomach or duodenal ulcers. The symptoms of ulcers are stomach pain and discomfort (indigestion) felt between the navel and the breast bone (may affect up to 1 in 100 people)
- bleeding in the stomach or intestines. This may cause you to pass black tar like stools or visible blood from the rectum (may affect up to 1 in 100 people)
- seizures (fits) or convulsions (may affect up to 1 in 100 people)
- fever with muscle stiffness, sweating or a lowered level of consciousness (a disorder called “Neuroleptic Malignant Syndrome”) (may affect up to 1 in 10,000 people)
- muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell, have a high temperature or have dark urine. They may be caused by an abnormal muscle breakdown which can be life threatening and lead to kidney problems (a condition called rhabdomyolysis) (may affect up to 1 in 10,000 people)
- fast, irregular heartbeat and fainting, which could be symptoms of a life-threatening condition known as Torsade de Pointes (frequency cannot be estimated from the available data)
Other side effects
Very common side effects (may affect more than 1 in 10 people):
- diarrhoea
- headache
Common side effects (may affect up to 1 in 10 people):
- muscle cramp
- tiredness
- difficulty in sleeping (insomnia)
- the common cold
- hallucinations (seeing or hearing things that are not really there)
- unusual dreams including nightmares
- agitation
- aggressive behaviour
- fainting
- dizziness
- stomach feeling uncomfortable
- rash
- passing urine uncontrollably
pain
- accidents (patients may be more prone to falls and accidental injury)
Uncommon side effects (may affect up to 1 in 100 people):
- slow heart beat
- salivary hypersecretion
Rare side effects (may affect up to 1 in 1000 people):
stiffness, shaking or uncontrollable movement especially of the face and tongue but also of the limbs
Not known (frequency cannot be estimated from the available data)
- Changes in the heart activity which can be seen on an electro-cardiogram (ECG) called ‘prolonged QT interval’
- libido increased, hypersexuality
- Pisa syndrome (a condition involving involuntary muscle contraction with abnormal bending of the body and head to one side)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Donepezil
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Donepezil contains
The active substance is Donepezil hydrochloride. Each tablet contains 5 mg or 10 mg of Donepezil hydrochloride.
The other ingredients are Microcrystalline cellulose, Colloidal anhydrous silica, Crospovidone (Type A), Aspartame, Sucralose, Peppermint flavour 501500 TP0504, Strawberry flavour 052311AP055, Mannitol, Sodium Stearyl Fumarate, Magnesium stearate.
Additionally, the 10 mg orodispersible tablet contains Ferric oxide (Yellow)
What Donepezil looks like and contents of the pack
05 mg: Donepezil Hydrochloride is White to off white, round shape, flat face beveled edge, uncoated tablet plain on both sides.
10 mg: Donepezil Hydrochloride is Pale yellow to yellow, round shape, flat face beveled edge, uncoated tablet plain on both sides.
Alu/Alu blister packs with desiccant of 7, 14, 28, 30, 50, 56, 60, 98 and 120 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Zydus Pharmaceuticals UK Ltd
Sandretto Building Weedon
Northampton NN7 4PP UK
This leaflet was last revised in Nov-2025.
To request a copy of this leaflet in Braille, large print or audio format, contact the licence holder at the above address or telephone: 0800 9956034 / email: DrugSafety@ ZydusUK.com
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