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DONEPEZIL HYDROCHLORIDE 10MG TABLETS

Active substance: DONEPEZIL HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

ARICEPT® 10MG TABLETS /
DONEPEZIL HYDROCHLORIDE 10MG TABLETS
(donepezil hydrochloride)
Your medicine is available using either of the above names but will
be referred to as Aricept throughout this leaflet.
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.
2.
3.
4.
5.
6.

What Aricept is and what it is used for
Before you take Aricept
How to take Aricept
Possible side effects
How to store Aricept
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, 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, 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.

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Pregnancy and breast-feeding

Aricept should not be used while breast-feeding.
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 5mg (one white tablet) every
night. After one month, your doctor may tell you to take 10mg
(one yellow tablet) every night.
Swallow your Aricept 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
10mg 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 strip is as
follows:
LUN
MON

MAR
TUE

MER
WED

JEU
THU

VEN
FRI

SAM
SAT

DIM
SUN

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.
fever with muscle stiffness, sweating or a lowered level of
consciousness (a disorder called “Neuroleptic Malignant
Syndrome”).
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).

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 get serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.

5. How to store Aricept

6. Further information
What do Aricept tablets contain?

The active ingredient in Aricept is donepezil hydrochloride.
Aricept is available as yellow tablets containing 10mg
donepezil hydrochloride (equivalent to 9.12mg donepezil free
base).
The tablets also contain the following inactive ingredients:
lactose, maize starch, microcrystalline cellulose,
hydroxypropyl cellulose, magnesium stearate, hypromellose,
talc, macrogol, titanium dioxide (E171) and yellow iron oxide
(E172).

What do Aricept tablets look like?

Each round, yellow film coated tablet has ‘Aricept’ on one side
and ‘10’ on the other.

What is in a pack of Aricept?

The tablets come in calendar blister strips of 28 tablets.

Manufacturer:

Aricept is manufactured by: Laboratoire Pfizer S.A., 37401
Amboise Cedex, France.
Or
Pfizer PGM, 37530 Poce sur Cisse, France.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
PL: 08929/0012

POM

Leaflet revision and issue date (Ref): 05.11.12
ARICEPT® is a registered trademark of Eisai R&D Management
Co., Ltd.

Do not store 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 the tablets appear to be discoloured or show any other signs of
deterioration, take them back to your pharmacist who will advise
you.
If your doctor decides to stop the treatment, return any leftover
tablets to the pharmacist. Only keep them 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.

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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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