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ARICEPT 10 MG FILM-COATED TABLETS

Active substance(s): DONEPEZIL HYDROCHLORIDE

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500983/PL1f

®

Aricept 10 mg Film Coated Tablets
(donepezil hydrochloride)
Patient Information Leaflet
®
The name of your medicine is Aricept 10 mg Film Coated
Tablets, throughout this leaflet it will be referred to as
®
Aricept .
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 is and what it is used for
®
2) Before you take Aricept
®
3) How to take Aricept
4) Possible side effects
®
5) How to store Aricept
6) Further information
®

1) WHAT ARICEPT IS AND WHAT IT IS USED FOR
®
Aricept (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 is for use in adult patients only.

Pregnancy and breast-feeding
®
Aricept 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
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 .
®

3) HOW TO TAKE ARICEPT
®
How much Aricept 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 tablet 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.
®

For how long should you take Aricept ?
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
Do not stop taking the tablets unless told to do so by your
®
doctor. If you stop taking Aricept , the benefits of your
treatment will gradually fade away.

®

2) BEFORE YOU TAKE ARICEPT
®
Do NOT take Aricept
• if you are allergic (hypersensitive) to donepezil
hydrochloride, or to piperidine derivatives, or any of the
®
other ingredients of Aricept listed in section 6
®

Take special care with Aricept
®
Tell your doctor or pharmacist before starting to take Aricept
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 . This is because these
®
medicines may weaken or strengthen the effects of Aricept .
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, nonsteroidal 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, betablockers (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 . This is because
your medicine may affect the amount of anaesthetic needed.

®

If you take more Aricept 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 (lightheadedness or dizziness when standing), breathing problems,
losing consciousness and seizures (fits) or convulsions.
®

If you forget to take Aricept
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 can cause side effects, although
not everybody gets them.
The following side effects have been reported by people
®
taking Aricept .
Tell your doctor if you have any of these effects while you
®
are taking Aricept .
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).

®

Aricept 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 .

Very common side effects (affects more than 1 user in 10):
• diarrhoea
• feeling or being sick
• headaches

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 with food and drink
®
Food will not influence the effect of Aricept .
®
Aricept should not be taken with alcohol because alcohol
may change its effect.
continued overleaf

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
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
®
DO NOT use Aricept tablets after the expiry date that is
printed on the label. The expiry date refers to the last day of
that month.
Do not store this medicine above 30°C. Keep out of the sight
and reach of children.
If your doctor tells you to stop taking your medicine, you
should return any you have not used to 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.
If the tablets become discoloured or show signs of any
deterioration, consult your doctor or pharmacist who will tell
you what to do.
6) FURTHER INFORMATION
®
What do Aricept tablets contain?
• Each film-coated tablet contains 10 mg of donepezil
hydrochloride.
• The other ingredients are lactose monohydrate, maize
starch,
microcrystalline
cellulose,
hyprolose,
magnesium stearate, hypromellose, talc, macrogol,
titanium dioxide (E171) and synthetic yellow iron oxide
(E172).
®

What do Aricept tablets look like?
®
• Aricept 10 mg Film-Coated Tablets are yellow, round,
bi-convex film-coated tablets, plain on both sides.
®

What is in a pack of Aricept ?
The tablets are supplied in calendar blister packs of 28
tablets.
Product Licence Holder and Manufacturer
Procured from within the EU. Product Licence Holder Ginova
Ltd, repackager Ginova UK Ltd, both at St James’ House, 8
Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufactured by Pfizer PGM, Zone Industrielle, 29 route des
industries, 37530 Poce-sur-Cisse, France.
®

Aricept 10 mg Film-Coated Tablets
PL No: 18067/0322

POM

®

Aricept is a registered trademark of Eisai Co. Ltd.
th

This leaflet was last revised on 16 March 2015.
To request a copy of this leaflet in Braille, large print or audio
please call 01622 690172.

500983/PL1f

500985/PL1f

Donepezil Hydrochloride
10 mg Film Coated Tablets

Patient Information Leaflet
The name of your medicine is Donepezil Hydrochloride 10 mg
Film Coated Tablets, throughout this leaflet it will be referred
to as Donepezil Hydrochloride.
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 Donepezil Hydrochloride is and what it is used for
2) Before you take Donepezil Hydrochloride
3) How to take Donepezil Hydrochloride
4) Possible side effects
5) How to store Donepezil Hydrochloride
6) Further information
1) WHAT DONEPEZIL HYDROCHLORIDE IS AND WHAT IT
IS USED FOR
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.
Donepezil Hydrochloride is for use in adult patients only.
2) BEFORE YOU TAKE DONEPEZIL HYDROCHLORIDE
Do NOT take Donepezil Hydrochloride
• if you are allergic (hypersensitive) to donepezil
hydrochloride, or to piperidine derivatives, or any of the
other ingredients of Donepezil Hydrochloride listed in
section 6
Take special care with Donepezil Hydrochloride
Tell your doctor or pharmacist before starting to take
Donepezil Hydrochloride 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 Donepezil Hydrochloride. This is
because these medicines may weaken or strengthen the
effects of Donepezil Hydrochloride.
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, nonsteroidal 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, betablockers (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 Hydrochloride.
This is because your medicine may affect the amount of
anaesthetic needed.
Donepezil Hydrochloride 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 Hydrochloride.

Pregnancy and breast-feeding
Donepezil Hydrochloride 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
Donepezil Hydrochloride
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
Donepezil Hydrochloride.
3) HOW TO TAKE DONEPEZIL HYDROCHLORIDE
How much Donepezil Hydrochloride 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 Donepezil Hydrochloride tablet 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.
For how long should you take Donepezil Hydrochloride?
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 Donepezil Hydrochloride
Do not stop taking the tablets unless told to do so by your
doctor. If you stop taking Donepezil Hydrochloride, the
benefits of your treatment will gradually fade away.
If you take more Donepezil Hydrochloride 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 (lightheadedness or dizziness when standing), breathing problems,
losing consciousness and seizures (fits) or convulsions.
If you forget to take Donepezil Hydrochloride
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, Donepezil Hydrochloride can cause side
effects, although not everybody gets them.
The following side effects have been reported by people
taking Donepezil Hydrochloride.
Tell your doctor if you have any of these effects while you
are taking Donepezil Hydrochloride.
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

Tell your doctor or pharmacist the name of your caregiver.
Your caregiver will help you to take your medicine as it is
prescribed.
Taking Donepezil Hydrochloride with food and drink
Food will not influence the effect of Donepezil Hydrochloride.
Donepezil Hydrochloride should not be taken with alcohol
because alcohol may change its effect.

continued overleaf

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
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 DONEPEZIL HYDROCHLORIDE
DO NOT use Donepezil Hydrochloride tablets after the expiry
date that is printed on the label. The expiry date refers to the
last day of that month.
Do not store this medicine above 30°C. Keep out of the sight
and reach of children.
If your doctor tells you to stop taking your medicine, you
should return any you have not used to 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.
If the tablets become discoloured or show signs of any
deterioration, consult your doctor or pharmacist who will tell
you what to do.
6) FURTHER INFORMATION
What do Donepezil Hydrochloride tablets contain?
• Each film-coated tablet contains 10 mg of donepezil
hydrochloride.
• The other ingredients are lactose monohydrate, maize
starch,
microcrystalline
cellulose,
hyprolose,
magnesium stearate, hypromellose, talc, macrogol,
titanium dioxide (E171) and synthetic yellow iron oxide
(E172).
What do Donepezil Hydrochloride tablets look like?
• Donepezil Hydrochloride 10 mg Film-Coated Tablets
are yellow, round, bi-convex film-coated tablets, plain
on both sides.
What is in a pack of Donepezil Hydrochloride?
The tablets are supplied in calendar blister packs of 28
tablets.
Product Licence Holder and Manufacturer
Procured from within the EU. Product Licence Holder Ginova
Ltd, repackager Ginova UK Ltd, both at St James’ House,
8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufactured by Pfizer PGM, Zone Industrielle, 29 route des
industries, 37530 Poce-sur-Cisse, France.
Donepezil Hydrochloride 10 mg Film-Coated Tablets
PL No: 18067/0322
POM
th

This leaflet was last revised on 16 March 2015.
To request a copy of this leaflet in Braille, large print or audio
please call 01622 690172.

500985/PL1f

Expand view ⇕

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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