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ARICEPT 10MG TABLETS

Active substance(s): DONEPEZIL HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
®
ARICEPT 5mg TABLETS/ DONEPEZIL HYDROCHLORIDE 5mg TABLETS
®
ARICEPT 10mg TABLETS/ DONEPEZIL HYDROCHLORIDE 10mg TABLETS
(donepezil hydrochloride)
This medicine is available as any of the above names but will be referred to as Aricept Tablets
throughout the following:
You and your caregiver should read all of this leaflet carefully before you start taking this
medicine.

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. Do not pass it on to others. It may harm them, even if
their symptoms are the same as yours.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet
1. What Aricept Tablets are and what they are used for
2. Before you take Aricept Tablets
3. How to take Aricept Tablets
4. Possible side effects
5. How to store Aricept Tablets
6. Further information
1. WHAT ARICEPT TABLETS ARE AND WHAT THEY ARE USED FOR
Aricept Tablets (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 break down 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.
Aricept Tablets is for use in adult patients only.
2. BEFORE YOU TAKE ARICEPT TABLETS
Do NOT take Aricept Tablets
• if you are allergic (hypersensitive) to donepezil hydrochloride, or to piperidine derivatives, or any of
the other ingredients of Aricept Tablets listed in section 6
Take special care with Aricept Tablets
Tell your doctor or pharmacist before starting to take Aricept Tablets if you have or have had:
• stomach or duodenal ulcers
• seizures (fits) or convulsions
• a heart condition (irregular or very slow heartbeat)
• 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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicine.
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 sometime in the future if
you continue to take Aricept Tablets. This is because these medicines may weaken or strengthen the
effects of Aricept Tablets.
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
• 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 Aricept Tablets. This is because your medicine
may affect the amount of anaesthetic needed.
Aricept Tablets 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
Aricept Tablets.
Tell your doctor or pharmacist the name of your caregiver. Your caregiver will help you to take your
medicine as it is prescribed.
Taking Aricept Tablets with food and drink
Food will not influence the effect of Aricept Tablets.
Aricept Tablets should not be taken with alcohol because alcohol may change its effect.
Pregnancy and breast-feeding
Aricept Tablets should not be used while breastfeeding.
If you are pregnant, or think you might be pregnant, ask your doctor for advice before taking any
medicine.
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.
Important information about some of the ingredients of Aricept Tablets
This medicine contains lactose monohydrate. If you have been told by your doctor that you have
intolerance to some sugars, you should contact your doctor before taking Aricept Tablets.
3. HOW TO TAKE ARICEPT TABLETS
How much Aricept Tablets should you take?
Usually, you will start by taking 5 mg (one white tablet) every night. After one month, your doctor may
tell you to take 10 mg (one yellow tablet) every night.
Swallow your Aricept Tablets with a drink of water before you go to bed at 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.
The translation of the days of the week on the blister strips is as follows:
Mon (LUN)
Tues (MAR)
Wed (MER)
Thurs (JEU)
Fri (VEN)
Sat (SAM)
Sun (DIM)
For how long should you take Aricept Tablets?
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 stop taking Aricept Tablets
Do not stop taking the tablets unless told to do so by your doctor. If you stop taking Aricept Tablets,
the benefits of your treatment will gradually fade away.
If you take more Aricept Tablets than you should
DO NOT take more than one tablet each day. Call your doctor immediately if you take more than you
should. If you cannot contact your doctor, contact the local hospital Accident and Emergency
department at once. Always take the tablets and 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 Aricept Tablets
If you forget to take a tablet, just take one tablet the following day 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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Aricept Tablets can cause side effects, although not everybody gets them.
The following side effects have been reported by people taking Aricept Tablets.
Tell your doctor if you have any of these effects while you are taking Aricept Tablets.
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
(affects 1 to 10 users in 10,000).
• stomach or duodenal ulcers. The symptoms of ulcers are stomach pain and discomfort (indigestion)
felt between the navel and the breast bone (affects 1 to 10 users in 1,000).
• bleeding in the stomach or intestines. This may cause you to pass black tar-like stools or visible
blood from the rectum (affects 1 to 10 users in 1,000).
• seizures (fits) or convulsions (affects 1 to 10 users in 1,000).
• fever with muscle stiffness, sweating or a lowered level of consciousness (a disorder called
"Neuroleptic Malignant Syndrome") (affects less than 1 user in 10,000).
Very common side effects (affects more than 1 user in 10):
• diarrhoea
• feeling or being sick
• headaches
Common side effects (affects 1 to 10 users in 100):
• 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 (affects 1 to 10 users in 1,000):
• slow heartbeat
Rare side effects (affects 1 to 10 users in 10,000):
• stiffness, shaking or uncontrollable movement especially of the face and tongue but also of the
limbs
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
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. By reporting side effects you can help provide more information on
the safety of this medicine.
5. HOW TO STORE ARICEPT TABLETS
• Do not use after the expiry date printed on the carton label or blister strip. The expiry date refers to
the last day of that month.
• Do not store above 30°C.
• Keep all medicines out of the sight and reach of children.
• If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe
disposal. Only keep the tablets if your doctor tells you to.
• If the tablets become discoloured or show signs of any deterioration, you should seek the advice of
your pharmacist.
• 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.
6. FURTHER INFORMATION
Your medicine is called Aricept Tablets. Each tablet contains either 5mg or 10mg of the active
ingredient donepezil hydrochloride equivalent to 4.56mg and 9.12mg respectively of donepezil
freebase.
The 5mg tablets are round, white and coded ‘ARICEPT’ on one side and ‘5’ on the reverse.
The 10mg tablets are round, yellow and coded ‘ARICEPT’ on one side and ‘10’ on the reverse.
Aricept Tablets also contain the following inactive ingredients:
5mg Tablets: lactose monohydrate, magnesium stearate, microcrystalline cellulose,
hydroxypropylcellulose, talc, maize starch, macrogol, hypromellose, titanium dioxide (E171).
10mg Tablets: lactose monohydrate, magnesium stearate, microcrystalline cellulose,
hydroxypropylcellulose, talc, maize starch, macrogol, hypromellose, titanium dioxide (E171) and
yellow iron oxide (E172).
Aricept Tablets are available as calendar blister packs of 28 tablets.
PL No: 15814/0454
Aricept 5mg Tablets / Donepezil hydrochloride 5mg Tablets POM
PL No: 15814/0460
Aricept 10mg Tablets / Donepezil hydrochloride 10mg Tablets
This product is manufactured by Pfizer PGM, 29, route des Industries, Poce-sur-Cisse, 37530, France
and is procured from within the EU and repackaged by the Product Licence holder: OPD Laboratories
Ltd, Unit 6 Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.) 20/03/2015
Aricept is a registered Trade Mark of Eisai Ltd.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

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