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ARICEPT EVESS 5MG ORODISPERSIBLE TABLETS/ DONEPEZIL HYDROCHLORIDE 5MG ORODISPERSIBLE TABLETS

Active substance(s): DONEPEZIL HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
®

ARICEPT EVESS 5mg ORODISPERSIBLE TABLETS
(donepezil hydrochloride)
You and your caregiver should read all of this
Especially tell your doctor if you are taking any of
leaflet carefully before you start taking this
the following types of medicines:
medicine.
other Alzheimer’s disease medicines, e.g.
galantamine
Keep this leaflet. You may need to read it
again.
pain killers or treatment for arthritis e.g.
aspirin, non-steroidal anti-inflammatory
If you have any further questions, ask your
doctor or pharmacist.
(NSAID) drugs such as ibuprofen, or
diclofenac sodium
This medicine has been prescribed for you. Do
not pass it on to others. It may harm them,
anticholinergics medicines, e.g. tolterodine
even if their symptoms are the same as yours.
antibiotics e.g. erythromycin, rifampicin
If any of the side effects get serious, or if you
anti-fungal medicine e.g. ketoconazole
notice any side effects not listed in this leaflet,
anti-depressants e.g. fluoxetine
please tell your doctor or pharmacist.
anticonvulsants e.g. phenytoin,
carbamazepine
The name of your medicine is ARICEPT® EVESS
medication for a heart condition e.g. quinidine,
5mg ORODISPERSIBLE TABLETS but it will be
beta-blockers (propanolol and atenolol)
referred to as ARICEPT Evess throughout this
muscle relaxants e.g. diazepam,
leaflet. Please note that the leaflet also contains
succinylcholine
information about other strength such as
general anaesthetic
ARICEPT® EVESS 10mg.
medicines obtained without a prescription e.g.
IN THIS LEAFLET:
herbal remedies
1. What ARICEPT Evess is and what it is used
If you are going to have an operation that requires
for
you to have a general anaesthetic, you should tell
2. Before you take ARICEPT Evess
your doctor and the anaesthetist that you are
3. How to take ARICEPT Evess
taking ARICEPT Evess. This is because your
4. Possible side effects
medicine may affect the amount of anaesthetic
5. How to store ARICEPT Evess
needed.
6. Further information
ARICEPT Evess can be used in patients with
kidney disease or mild to moderate liver disease.
1. WHAT ARICEPT EVESS IS AND WHAT IT IS
Tell your doctor first if you have kidney or liver
USED FOR
disease. Patients with severe liver disease should
ARICEPT Evess (donepezil hydrochloride)
not take ARICEPT Evess. Tell your doctor or
belongs to a group of medicines called
pharmacist the name of your caregiver. Your
acetylcholinesterase inhibitors. Donepezil
caregiver will help you to take your medicine as it
increases the levels of a substance (acetylcholine)
is prescribed.
in the brain involved in memory function by
slowing down the breakdown of acetylcholine.
Taking ARICEPT Evess with food and drink
It is used to treat the symptoms of dementia in people
Food will not influence the effect of ARICEPT
diagnosed as having mild and moderately severe
Evess.
Alzheimer’s disease. The symptoms include
ARICEPT Evess should not be taken with alcohol
increasing memory loss, confusion and behavioural
because alcohol may change its effect.
changes. As a result, sufferers of Alzheimer’s disease
Pregnancy and breast-feeding
find it more and more difficult to carry out their normal
ARICEPT Evess should not be used while breastdaily activities.
feeding.
ARICEPT Evess is for use in adult patients only.
If you are pregnant, or think you might be
pregnant, ask your doctor for advice before taking
2. BEFORE YOU TAKE ARICEPT EVESS
any medicine.
Do NOT take ARICEPT EVESS
Driving and using machines
if you are allergic (hypersensitive) to donepezil
Alzheimer’s disease may impair your ability to
hydrochloride, or to piperidine derivatives, or
drive or operate machinery and you must not
any of the other ingredients of ARICEPT
perform these activities unless your doctor tells
Evess listed in section 6.
you that it is safe to do so.
Take special care with ARICEPT EVESS
Also, your medicine can cause tiredness,
Tell your doctor or pharmacist before starting to
dizziness and muscle cramp. If you experience
take ARICEPT Evess if you have or have had:
any of these effects you must not drive or operate
stomach or duodenal ulcers
machinery.
seizures (fits) or convulsions
a heart condition (irregular or very slow
3. HOW TO TAKE ARICEPT EVESS
heart beat)
How much ARICEPT Evess should you take?
asthma or other long-term lung disease
Usually, you will start by taking 5mg (one white
liver problems or hepatitis
tablet) every night before you go to bed. After one
difficulty passing urine or mild kidney disease
month, your doctor may tell you to take 10mg (one
Also tell your doctor if you are pregnant or think
yellow tablet) every night before you go to bed.
you might be pregnant.
The tablet should be placed on your tongue and
Taking other medicines
allowed to disintegrate before swallowing, with or
without water, according to your preference.
Please tell your doctor or pharmacist if you are
taking, or have recently taken, any other medicine.
The tablet strength you will take may change
This includes medicines that your doctor has not
depending on the length of time you have been
prescribed for you but which you have bought
taking the medicine and on what your doctor
yourself from a chemist/pharmacist. It also applies
recommends. The maximum recommended dose
to medicines you may take sometime in the future
is 10mg each night.
if you continue to take ARICEPT Evess.
Always follow your doctor’s, or pharmacist’s
This is because these medicines may weaken or
advice about how and when to take your medicine.
strengthen the effects of ARICEPT Evess.
Do not alter the dose yourself without your
doctor’s advice.

For how long should you take ARICEPT
Evess?
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 Evess
Do not stop taking the tablets unless told to do so
by your doctor. If you stop taking ARICEPT Evess,
the benefits of your treatment will gradually fade
away.
If you take more ARICEPT Evess 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 Evess
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 Evess can cause side
effects, although not everybody gets them.
The following side effects have been reported by
people taking ARICEPT Evess.
Tell your doctor if you have any of these
effects while you are taking ARICEPT Evess.
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 heart beat
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 EVESS
Keep out of the sight and reach of children
This medicinal product does not require any
special storage condition. As with all medicines,
the tablets should be kept in a safe place
If your tablets become discoloured or show any
signs of deterioration, seek the advice of your
pharmacist.
Do not take your tablets after the expiry date
which is stated on the carton/blister label after
‘Exp’. The expiry date refers to the last day of that
month
Remember if your doctor tells you to stop taking
this medicine, return any unused tablets to your
pharmacist for safe disposal. Only keep this
medicine if your doctor tells 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.
6. FURTHER INFORMATION
What do ARICEPT Evess tablets contain?
The active ingredient in ARICEPT Evess is
donepezil hydrochloride. Each tablet contains
5mg of donepezil hydrochloride equivalent to
4.56mg donepezil free base as the active
ingredient.
Other ingredients include: mannitol, colloidal
anhydrous silica, carrageenan and polyvinyl
alcohol.
What do ARICEPT Evess tablets look like?
Each ARICEPT Evess 5mg tablet is a white,
round, orodispersible tablet embossed with ‘5’
on one side and 'ARICEPT' on the other
What is in a pack of ARICEPT Evess?
The tablets are supplied in calendar blister
strips each containing 28 tablets.
Manufactured by: Pfizer PGM, 29,
Route des Industries, 37530 Pocé-sur-Cisse,
France
Procured from within the EU and repackaged
by the Product Licence holder: B&S Healthcare,
Unit 4, Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
ARICEPT® EVESS 5mg ORODISPERSIBLE
Tablets; PL No: 18799/1883
POM
Leaflet date: 12.06.2015

ARICEPT EVESS is a trademark of Eisai Ltd.

PACKAGE LEAFLET: INFORMATION FOR THE USER

DONEPEZIL HYDROCHLORIDE 5mg ORODISPERSIBLE TABLETS
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.

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

The name of your medicine is DONEPEZIL
HYDROCHLORIDE 5mg ORODISPERSIBLE
TABLETS but it will be referred to as DONEPEZIL
throughout this leaflet. Please note that the leaflet
also contains information about other strength
such as DONEPEZIL HYDROCHLORIDE 10mg.

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.

IN THIS LEAFLET:
1. What DONEPEZIL is and what it is used for
2. Before you take DONEPEZIL
3. How to take DONEPEZIL
4. Possible side effects
5. How to store DONEPEZIL
6. Further information

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.

1. WHAT DONEPEZIL IS AND WHAT IT IS
USED FOR
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. BEFORE YOU TAKE DONEPEZIL
Do NOT take DONEPEZIL
if you are allergic (hypersensitive) to donepezil
hydrochloride, or to piperidine derivatives, or
any of the other ingredients of DONEPEZIL
listed in section 6.
Take special care with DONEPEZIL
Tell your doctor or pharmacist before starting to
take 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.
Taking other medicines

Taking DONEPEZIL with food and drink
Food will not influence the effect of DONEPEZIL.
DONEPEZIL should not be taken with alcohol
because alcohol may change its effect.
Pregnancy and breast-feeding
DONEPEZIL 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.
3. HOW TO TAKE DONEPEZIL
How much DONEPEZIL should you take?
Usually, you will start by taking 5mg (one white
tablet) every night before you go to bed. After one
month, your doctor may tell you to take 10mg (one
yellow tablet) every night before you go to bed.
The tablet should be placed on your tongue and
allowed to disintegrate before swallowing, with or
without water, according to your preference.
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 10mg each night.
Always follow your doctor’s, or pharmacist’s
advice about how and when to take your medicine.

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.

Do not alter the dose yourself without your
doctor’s advice.

This is because these medicines may weaken or
strengthen the effects of DONEPEZIL.

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.

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

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.

If you take more DONEPEZIL 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 DONEPEZIL
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 can cause side
effects, although not everybody gets them.
The following side effects have been reported by
people taking DONEPEZIL.

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 DONEPEZIL
Keep out of the sight and reach of children
This medicinal product does not require any
special storage condition. As with all medicines,
the tablets should be kept in a safe place

Tell your doctor if you have any of these
effects while you are taking DONEPEZIL.

If your tablets become discoloured or show any
signs of deterioration, seek the advice of your
pharmacist.

Serious side effects:
You must tell your doctor immediately if you notice
these serious side effects mentioned. You may
need urgent medical treatment.

Do not take your tablets after the expiry date
which is stated on the carton/blister label after
‘Exp’. The expiry date refers to the last day of that
month

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 heart beat

Remember if your doctor tells you to stop taking
this medicine, return any unused tablets to your
pharmacist for safe disposal. Only keep this
medicine if your doctor tells 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.
6. FURTHER INFORMATION
What do DONEPEZIL tablets contain?
The active ingredient in DONEPEZIL is
donepezil hydrochloride. Each tablet contains
5mg of donepezil hydrochloride equivalent to
4.56mg donepezil free base as the active
ingredient.
Other ingredients include: mannitol, colloidal
anhydrous silica, carrageenan and polyvinyl
alcohol.
What do DONEPEZIL tablets look like?
Each DONEPEZIL 5mg tablet is a white,
round, orodispersible tablet embossed with ‘5’
on one side and ' ARICEPT ' on the other
What is in a pack of DONEPEZIL?
The tablets are supplied in calendar blister
strips each containing 28 tablets.
Manufactured by: Pfizer PGM, 29,
Route des Industries, 37530 Pocé-sur-Cisse,
France
Procured from within the EU and repackaged
by the Product Licence holder: B&S Healthcare,
Unit 4, Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
DONEPEZIL HYDROCHLORIDE 5mg
ORODISPERSIBLE Tablets;
PL No: 18799/1883
Leaflet date: 12.06.2015

POM

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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