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DONEPEZIL 10MG FILM COATED TABLET

Active substance(s): DONEPEZIL HYDROCHLORIDE

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Package leaflet: Information for the user
DONEPEZIL 5 mg Film Coated Tablets
DONEPEZIL 10 mg Film Coated Tablets
(Donepezil Hydrochloride)
Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or pharmacist.
 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 of the side effects talk to your doctor or pharmacist . This includes any side possible
effects not listed in this leaflet..See section 4.
What is in this leaflet
1.
What DONEPEZIL is and what it is used for
2.
What you need to know before you take DONEPEZIL
3.
How to take DONEPEZIL
4.
Possible side effects
5.
How to store DONEPEZIL
6.
Contents of the pack and other information
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 take 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 toyour doctor or pharmacist before taking DONEPEZIL if you have or have had:
 stomach or duodenal ulcers
 seizures (fits) or convulsions
 a heart condition (irregular or very slow heart beat)
 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:












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
antibiotics e.g. erythromycin, rifampicin
anti-fungal medicine e.g. ketoconazole
anti-depressants e.g. fluoxetine
anticonvulsants e.g. phenytoin, carbamazepine
medication for a heart condition e.g. quinidine, beta-blockers (propanolol 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 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 breastfeeding.
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.
DONEPEZIL contains lactose
If you have been told by your doctor that you have intolerance to some sugars, you should contact your
doctor before taking DONEPEZIL.
3.

How to take 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. After
one month, your doctor may tell you to take 10 mg (one yellow tablet) 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.
Do not alter the dose yourself without your doctor’s advice.
How to take your medicine
Swallow your DONEPEZIL tablet with a drink of water before you go to bed at night.
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.
Overdosesymptoms 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 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 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 (a disorder called
"Neuroleptic Malignant Syndrome") (may affect up to 1 in 10,000 people)



:




:


















:

Very common side effects (may affect more than 1 in 10 people)
diarrhoea
feeling sick
headache
Common side effects (may affect up to 1 in 10 people)
muscle cramp
tiredness
difficulty in sleeping (insomnia)
the 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
rash
itching
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
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
Reporting of side effects
If you get any the 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.
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 outer carton and blister or bottle (EXP).
The expiry date refers to the last day of that month.
Do not store this medicine above 30°C.
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. Two different strengths of tablets are available. Each
5 mg tablet contains 5 mg of donepezil hydrochloride and each 10 mg tablet contains 10 mg of donepezil
hydrochloride.
The other ingredients are lactose monohydrate, maize starch, cellulose microcrystalline, hyprolose,
magnesium stearate, hypromellose, talc, macrogol, and titanium dioxide (E171).
Additionally, the 10 mg tablet contains synthetic yellow iron oxide (E172).

What DONEPEZIL looks like and contents of the pack



DONEPEZIL film coated 5 mg tablets are white film coated tablets marked '5' on one side.
DONEPEZIL film coated 10 mg tablets are yellow film coated tablets marked '10' on one side.

DONEPEZIL is available in packs of :

7, 14, 28, 30, 50, 56, 60, 84, 98, 100, 112 or 120 tablets in blister strips


28, 30 or 100 tablets in HDPE bottles

Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is:
Eisai Ltd.,
European Knowledge Centre,
Mosquito Way
Hatfield
Hertfordshire,
AL10 9SN
UK.
DONEPEZIL film coated tablets are manufactured for Eisai Ltd. by:
Eisai Manufacturing Ltd.,
Mosquito Way
Hatfield
Hertfordshire,
AL10 9SN
UK.
or

Fareva Amboise
Zone Industrielle
29, route des Industries
37530 Pocé-sur-Cisse
France
This medicinal product is authorised in the member states of the EEA under the following names
Only in QRD Template (Not to be included in the UK mock-up)
Countries
United Kingdom
France
Austria
Denmark,
Greece
Ireland
Italy
Portugal

This leaflet was last revised in MM/YYYY.
 Copyright Eisai Limited

Name of Product
Donepezil 5 & 10 mg Film Coated Tablets
Donepezil Pfizer 5 mg, comprimé pelliculé
Donepezil Pfizer 10 mg, comprimé pelliculé
Donepezil Pfizer 5 mg Filmtabletten
Donepezil Pfizer 10 mg Filmtabletten
Donepezil Pfizer 5 mg / 10 mg Filmovertrukket tablet
Donepezil Pfizer 5 mg / 10 mg Επικαλυμμένο με λεπτό
υμένιο δισ
Donepezil Pfizer 5 mg & 10 mg Film Coated Tablets
Donepezil Pfizer 5 mg / 10 mg Compressa rivestita con
film
Donepezilio Pfizer

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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