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DONEPEZIL HYDROCHLORIDE 10MG FILM-COATED TABLET

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MOCK-UP
PACKAGE LEAFLET: INFORMATION FOR THE USER

Aricept® 10mg Film-coated Tablets
(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.
The name of your medicine is Aricept 10mg
Film-coated Tablets but will be referred to as
Aricept throughout this leaflet. Please note
that the leaflet also contains information about
the other strength: Aricept 5mg Film-coated
tablets.
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.
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, 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.
This is because your medicine may affect
the amount of anaesthetic needed.
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.
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.
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. 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.
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 (light-headedness
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).
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.
5. HOW TO STORE ARICEPT
Do not store this medicine above 30°C.
Keep out of the sight and reach of children.
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.
If your doctor tells you to stop taking your
medicine, you should return any you have not
used to your pharmacist.
If your tablets become discoloured or show
any signs of deterioration, you should seek the
advice of your pharmacist.
6. FURTHER INFORMATION
What does Aricept contain?


The active substance is donepezil
hydrochloride. Each film-coated tablet
contains 10mg of donepezil hydrochloride.



The other ingredients are lactose
monohydrate, maize starch,
microcrystalline cellulose, hydroxypropyl
cellulose, magnesium stearate,
hypromellose, talc, macrogol, titanium
dioxide (E171) and yellow iron oxide
(E172).

What does Aricept look like?


Aricept are yellow, round, biconvex filmcoated tablets embossed with „ARICEPT‟
on one side and „10‟ on the other.

What is in a pack of Aricept?
The tablets are supplied in calendar blister
packs of 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 10mg Film-coated Tablets –
PL No: 18799/2045
Leaflet date: 11.04.2013
Aricept is a trademark of Pfizer Ltd.

POM

PACKAGE LEAFLET: INFORMATION FOR THE USER

Donepezil hydrochloride 10mg Film-coated 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.
The name of your medicine is Donepezil
hydrochloride 10mg Film-coated Tablets but
will be referred to as Donepezil throughout this
leaflet. Please note that this leaflet also
contains information about the other strength:
Donepezil hydrochloride 5mg Film-coated
Tablets.
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
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 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 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
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.
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
 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.
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.
Important information about some of the
ingredients of DONEPEZIL
This medicine 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?
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 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?
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
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 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.
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
(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.
5. HOW TO STORE DONEPEZIL
Do not store this medicine above 30°C.
Keep out of the sight and reach of children.
DO NOT use DONEPEZIL tablets after the
expiry date that is printed on the label. The
expiry date refers to the last day of that month.
If your doctor tells you to stop taking your
medicine, you should return any you have not
used to your pharmacist.
If your tablets become discoloured or show
any signs of deterioration, you should seek the
advice of your pharmacist.
6. FURTHER INFORMATION
What does DONEPEZIL contain?


The active substance is donepezil
hydrochloride. Each film-coated tablet
contains 10mg of donepezil hydrochloride.



The other ingredients are lactose
monohydrate, maize starch,
microcrystalline cellulose, hydroxypropyl
cellulose, magnesium stearate,
hypromellose, talc, macrogol, titanium
dioxide (E171) and yellow iron oxide
(E172).

What does DONEPEZIL look like?


DONEPEZIL are yellow, round, biconvex
film-coated tablets embossed with
„ARICEPT‟ on one side and „10‟ on the
other.

What is in a pack of DONEPEZIL?
The tablets are supplied in calendar blister
packs of 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 10mg Film-coated
Tablets –
PL No: 18799/2045
POM
Leaflet date: 11.04.2013

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Further information

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