Patient leaflet - Donepezil 10 mg orodispersible tablets
What Donepezil is and what it is used for
Donepezil 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.
Donpezil is used to treat the symptoms of dementia in people diagnosed as having mild to 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.
What you need to know before you take Donepezil
Do not take Donepezil
if you are allergic to
* donepezil hydrochloride or
* piperidine derivatives, which are similar substances to donepezil, or * any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Donepezil. If any of the following concerns you, you or your caregiver should inform your doctor or pharmacist.
* stomach or duodenal ulcers
* seizures (fits) or convulsions (Donepezil may have the potential to cause seizures)
* 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 have ‘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.
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.
Especially tell your doctor if you are taking any of the following types of medicines:
* 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 * anticholinergics medicines, e.g. tolterodine
* medicines for bacterial infections (such as clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin)
* anti-fungal medicine e.g. ketoconazole
* medicines for depression (e.g. citalopram, escitalopram, amitriptyline, fluoxetine)
* medicines for psychoses (e.g. pimozide, sertindole, ziprasidone) * anticonvulsants e.g. phenytoin, carbamazepine
* 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
Donepezil should not be used while breastfeeding.
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.
Driving and using machines
Alzheimer’s disease may impair your ability to drive or operate machines. Do not perform these activities unless your doctor has confirmed that this is safe.
This medicine can cause fatigue, dizziness and muscle cramps particularly during the beginning of therapy and dose increase. If affected you must not drive or operate machines.
Donepezil Orodispersible Tablets contain aspartame and sodium This medicine contains 8.4 mg aspartame in each orodispersible tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
This medicine contains less than 1 mmol (23 mg) sodium, that is to say essentially “sodium-free”.
How to take Donepezil
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The usual dose is:
Adults and elderly patients
Donepezil 5 mg Orodispersible Tablets:
* Starting dose: 1 orodispersible tablet every night
* After one month: possible increase to 2 orodispersible tablets every night * Maximum dose: 2 orodispersible tablets every night.
Donepezil 10 mg Orodispersible Tablets:
* Starting dose: 5mg every night - please note Donepezil 10 mg Orodispersible Tablets can not be used for this dose (Donepezil 5 mg Orodispersible Tablets are available to start treatment)
* After one month: possible increase to 1 orodispersible tablet every night * Maximum dose: 1 orodispersible tablet every night.
Do not alter the dose yourself without your doctor’s advice. Patients with kidney dysfunction
You can take the usual dose as described above. No adjustment is required.
Patients with mild to moderate liver dysfunction
Your doctor will check your tolerance to Donepezil before increasing the dose.
Patients with severe liver dysfunction
Your doctor will decide if Donepezil is suitable for you. Patients with severe liver disease should not take Donepezil.
Method of administration
Take your orodispersible tablets at night before you go to bed, independently from meals. Place them on your tongue and let them disintegrate before swallowing, with or without water, according to your preference.
Duration of use
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.
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contact your doctor, contact the local hospital Accident and Emergency department at once. Always take the orodispersible tablets, this leaflet and/or the carton with you to the hospital so that the doctor knows what has been taken.
Symptoms of overdosing 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 Donepezil
If you forget to take an orodispersible tablet, just take one orodispersible tablet the following day at the usual time. Do not take a double dose to make up for a forgotten dose.
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 orodispersible tablets unless instructed by your doctor. Positive treatment results may gradually diminish if treatment is stopped.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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 feeling or 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. These are the symptoms of 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)
Other side effects that may occur:
Very common, may affect more than 1 in 10 people:
* diarrhoea
* nausea (feeling sick)
* headache
Common, may affect up to 1 in 10 people:
* muscle cramps
* tiredness
* difficulty in sleeping (insomnia)
* common cold
* loss of appetite
* hallucinations (seeing or hearing things that are not really there) * unusual dreams including nightmares
* agitation
* aggressive behaviour
* fainting
* dizziness
* stomach feeling uncomfortable
* vomiting
* rash
* itching
* passing urine uncontrollably
* pain
* accidents (patients may be more prone to falls and accidental injury)
Uncommon, may affect up to 1 in 100 people:
* slow heart beat
* minor increase of the muscle enzyme creatine kinase in blood tests
Frequency not known:
* Changes in the heart activity which can be seen on an electro-cardiogram (ECG) called ‘prolonged QT interval’
* Fast, irregular heart beat, fainting which could be symptoms of a life-threatening condition known as Torsade de Pointes
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 at 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.
How to store Donepezil
Keep out of the sight and reach of children.
Do not store above 25°C.
Do not take Donepezil after the expiry date, which is shown on the carton and blister after EXP. The expiry date refers to the last day of that month.
If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
If your doctor tells you to stop taking this medicine, take any remaining medicine back to the pharmacist for safe disposal. Only keep this medicine if your doctor advises you to.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
What Donepezil contains:
- The active substance is donepezil hydrochloride.
- Each tablet contains 10 mg of donepezil hydrochloride
The other ingredients are aspartame (E 951), croscarmellose sodium, iron oxide yellow (E 172), magnesium stearate, mannitol (E 421), cellulose microcrystalline, peppermint flavour, colloidal anhydrous silica and zinc sulfate monohydrate.
What Donepezil looks like and contents of the pack
Donepezil are yellow, slightly dotted, round, flat orodispersible tablets with debossment “10” on one side and plain on the other side.
Donepezil tablets are available in blister packs of 28 orodispersible tablets.
Manufacturer and Licence Holder
This medicine is manufactured by Salutas Pharma GmbH, Otto-von-Guericke-Alle 1, 39179 Barleben, Germany and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
PL 15184/2594 Donepezil 10 mg Orodispersible tablets
Leaflet revision date: 15/04/2025
Blind or partially sighted?
Is this leaflet hard to see or read? Phone Lexon (UK) Limited, Tel: 01527 505414 to obtain the leaflet in a format suitable for you
POM
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* This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
* If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
The name of your medicine is Donepezil 10 mg Orodispersible tablets but will be referred to as Donepezil throughout this leaflet. Please note that this leaflet contains information about another strength of this medicine Donepezil 5 mg Orodispersible tablets.
What is in this leaflet
What Donepezil is and what it is used for
Donepezil 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.
Donpezil is used to treat the symptoms of dementia in people diagnosed as having mild to 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.
What you need to know before you take Donepezil
Do not take Donepezil
if you are allergic to
* donepezil hydrochloride or
* piperidine derivatives, which are similar substances to donepezil, or * any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Donepezil. If any of the following concerns you, you or your caregiver should inform your doctor or pharmacist.
* stomach or duodenal ulcers
* seizures (fits) or convulsions (Donepezil may have the potential to cause seizures)
* 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 have ‘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.
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.
Especially tell your doctor if you are taking any of the following types of medicines:
* 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 * anticholinergics medicines, e.g. tolterodine
* medicines for bacterial infections (such as clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin)
* anti-fungal medicine e.g. ketoconazole
* medicines for depression (e.g. citalopram, escitalopram, amitriptyline, fluoxetine)
* medicines for psychoses (e.g. pimozide, sertindole, ziprasidone) * anticonvulsants e.g. phenytoin, carbamazepine
* 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
Donepezil should not be used while breastfeeding.
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.
Driving and using machines
Alzheimer’s disease may impair your ability to drive or operate machines. Do not perform these activities unless your doctor has confirmed that this is safe.
This medicine can cause fatigue, dizziness and muscle cramps particularly during the beginning of therapy and dose increase. If affected you must not drive or operate machines.
Donepezil Orodispersible Tablets contain aspartame and sodium This medicine contains 8.4 mg aspartame in each orodispersible tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
This medicine contains less than 1 mmol (23 mg) sodium, that is to say essentially “sodium-free”.
How to take Donepezil
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The usual dose is:
Adults and elderly patients
Donepezil 5 mg Orodispersible Tablets:
* Starting dose: 1 orodispersible tablet every night
* After one month: possible increase to 2 orodispersible tablets every night * Maximum dose: 2 orodispersible tablets every night.
Donepezil 10 mg Orodispersible Tablets:
* Starting dose: 5mg every night - please note Donepezil 10 mg Orodispersible Tablets can not be used for this dose (Donepezil 5 mg Orodispersible Tablets are available to start treatment)
* After one month: possible increase to 1 orodispersible tablet every night * Maximum dose: 1 orodispersible tablet every night.
Do not alter the dose yourself without your doctor’s advice. Patients with kidney dysfunction
You can take the usual dose as described above. No adjustment is required.
Patients with mild to moderate liver dysfunction
Your doctor will check your tolerance to Donepezil before increasing the dose.
Patients with severe liver dysfunction
Your doctor will decide if Donepezil is suitable for you. Patients with severe liver disease should not take Donepezil.
Method of administration
Take your orodispersible tablets at night before you go to bed, independently from meals. Place them on your tongue and let them disintegrate before swallowing, with or without water, according to your preference.
Duration of use
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.
1
1
2
2
3
3
4
5
6
contact your doctor, contact the local hospital Accident and Emergency department at once. Always take the orodispersible tablets, this leaflet and/or the carton with you to the hospital so that the doctor knows what has been taken.
Symptoms of overdosing 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 Donepezil
If you forget to take an orodispersible tablet, just take one orodispersible tablet the following day at the usual time. Do not take a double dose to make up for a forgotten dose.
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 orodispersible tablets unless instructed by your doctor. Positive treatment results may gradually diminish if treatment is stopped.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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 feeling or 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. These are the symptoms of 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)
Other side effects that may occur:
Very common, may affect more than 1 in 10 people:
* diarrhoea
* nausea (feeling sick)
* headache
Common, may affect up to 1 in 10 people:
* muscle cramps
* tiredness
* difficulty in sleeping (insomnia)
* common cold
* loss of appetite
* hallucinations (seeing or hearing things that are not really there) * unusual dreams including nightmares
* agitation
* aggressive behaviour
* fainting
* dizziness
* stomach feeling uncomfortable
* vomiting
* rash
* itching
* passing urine uncontrollably
* pain
* accidents (patients may be more prone to falls and accidental injury)
Uncommon, may affect up to 1 in 100 people:
* slow heart beat
* minor increase of the muscle enzyme creatine kinase in blood tests
Frequency not known:
* Changes in the heart activity which can be seen on an electro-cardiogram (ECG) called ‘prolonged QT interval’
* Fast, irregular heart beat, fainting which could be symptoms of a life-threatening condition known as Torsade de Pointes
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 at 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.
How to store Donepezil
Keep out of the sight and reach of children.
Do not store above 25°C.
Do not take Donepezil after the expiry date, which is shown on the carton and blister after EXP. The expiry date refers to the last day of that month.
If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
If your doctor tells you to stop taking this medicine, take any remaining medicine back to the pharmacist for safe disposal. Only keep this medicine if your doctor advises you to.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
What Donepezil contains:
- The active substance is donepezil hydrochloride.
- Each tablet contains 10 mg of donepezil hydrochloride
The other ingredients are aspartame (E 951), croscarmellose sodium, iron oxide yellow (E 172), magnesium stearate, mannitol (E 421), cellulose microcrystalline, peppermint flavour, colloidal anhydrous silica and zinc sulfate monohydrate.
What Donepezil looks like and contents of the pack
Donepezil are yellow, slightly dotted, round, flat orodispersible tablets with debossment “10” on one side and plain on the other side.
Donepezil tablets are available in blister packs of 28 orodispersible tablets.
Manufacturer and Licence Holder
This medicine is manufactured by LEK S.A., ul. Podlipie 16, 95-010 Stryków, Poland and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
PL 15184/2594 Donepezil 10 mg Orodispersible tablets
Leaflet revision date: 15/04/2025
Blind or partially sighted?
Is this leaflet hard to see or read? Phone Lexon (UK) Limited, Tel: 01527 505414 to obtain the leaflet in a format suitable for you
POM
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