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ARICEPT 10MG FILM-COATED TABLETS

Active substance(s): DONEPEZIL HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

ARICEPT® 5 mg Film Coated Tablets
ARICEPT® 10 mg 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.
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. W
 HAT 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

More information can be found on
the back of the leaflet

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 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 reach and sight 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.
6. FURTHER INFORMATION

What do ARICEPT tablets contain?
• The active substance is donepezil
hydrochloride. The 5 mg tablet contains
5 mg of donepezil hydrochloride and the
10 mg tablet contains 10 mg of donepezil
hydrochloride.
• The other ingredients are lactose
monohydrate, maize starch,
microcrystalline cellulose, hydroxypropyl
cellulose, magnesium stearate,
hypromellose, talc, macrogol, and
titanium dioxide (E171).
• Additionally, the 10 mg tablet contains
synthetic yellow iron oxide (E172).
What do ARICEPT tablets look like?
• 5 mg white tablets marked ‘ARICEPT’ on
one side and ‘5’ on the other.
• 10 mg yellow tablets marked ‘ARICEPT’
on one side and ‘10’ on the other.
What is in a pack of Aricept?
The tablets are supplied in packs of 7, 14,
28, 30, 50, 56, 60, 84, 98, 112 or 120 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisation Holder is:
Eisai Ltd.,
Mosquito Way
Hatfield
Herts.,
AL 10 9SN
UK.
ARICEPT tablets are manufactured for Eisai
Ltd. by:
Eisai Manufacturing Ltd.,
Mosquito Way
Hatfield
Herts.,
AL 10 9SN
UK.
This leaflet was last approved in Jan 2013

© Copyright Eisai Limited

2001437
ARF727

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in this proof after approval. Whilst we take extreme care
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8pt
UK
English
Tom Robertson
Two
22/10/2012

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Date

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Profile

2001437

Aricept 5/10mg PIL

Description

Item Code

Eisai

Customer

Measure bar should be 150mm at 100% scale

Pharma
Code

1058

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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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