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DONEPEZIL HYDROCHLORIDE 5MG TABLETS
Active substance(s): DONEPEZIL HYDROCHLORIDE
ARICEPT® 5MG TABLETS /
DONEPEZIL HYDROCHLORIDE 5MG TABLETS
Your medicine is available using either of the above names but
will be referred to as Aricept 5mg Tablets throughout this leaflet.
Also available as 10mg tablets.
You and your caregiver should read all of this
leaflet carefully before you start taking this
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or
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
In this leaflet:
What Aricept 5mg Tablets is and what it is used for
Before you take Aricept 5mg Tablets
How to take Aricept 5mg Tablets
Possible side effects
How to store Aricept 5mg Tablets
1. What Aricept 5mg Tablets is and what it is
Aricept 5mg Tablets (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
Aricept 5mg Tablets is for use in adult patients only.
2. Before you take Aricept 5mg Tablets
Do NOT take Aricept 5mg Tablets
if you are allergic (hypersensitive) to donepezil
hydrochloride, or to piperidine derivatives, or any of the
other ingredients of Aricept 5mg Tablets listed in section 6
Take special care with Aricept 5mg Tablets
Taking Aricept 5mg Tablets with food and drink
Food will not influence the effect of Aricept 5mg Tablets.
Aricept 5mg Tablets should not be taken with alcohol because
alcohol may change its effect.
Pregnancy and breast-feeding
Aricept 5mg Tablets should not be used while breast-feeding.
Tell your doctor or pharmacist before starting to take Aricept 5mg
Tablets 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
Driving and using machines
Also tell your doctor if you are pregnant or think you might be
Also, your medicine can cause tiredness, dizziness and muscle
cramp. If you experience any of these effects you must not drive
or operate machinery.
Taking other medicines
If you are pregnant, or think you might be pregnant, ask your
doctor for advice before taking any medicine.
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.
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 5mg Tablets. This is because these medicines may weaken
or strengthen the effects of Aricept 5mg Tablets.
Important information about some of the
ingredients of Aricept 5mg Tablets
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
medicines obtained without a prescription e.g. herbal
How much Aricept 5mg Tablets should you take?
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 5mg Tablets. This is
because your medicine may affect the amount of anaesthetic
Aricept 5mg Tablets 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 5mg Tablets.
Tell your doctor or pharmacist the name of your caregiver. Your
caregiver will help you to take your medicine as it is prescribed.
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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 5mg Tablets.
3. How to take Aricept 5mg Tablets
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 5mg 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
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.
For how long should you take Aricept 5mg Tablets?
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
If you stop taking Aricept 5mg Tablets
Do not stop taking the tablets unless told to do so by your doctor.
If you stop taking Aricept 5mg Tablets, the benefits of your
treatment will gradually fade away.
If you take more Aricept 5mg Tablets than you
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
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 5mg Tablets
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 5mg Tablets can cause side effects,
although not everybody gets them.
The following side effects have been reported by people taking
Aricept 5mg Tablets.
Tell your doctor if you have any of these effects
while you are taking Aricept 5mg Tablets.
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”) (affects less than 1 user in 10,000).
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
Very common side effects (affects more than 1 user
feeling or being sick
Common side effects (affects 1 to 10 users in 100):
difficulty in sleeping (insomnia)
the common cold
loss of appetite
hallucinations (seeing or hearing things that are not really
unusual dreams including nightmares
stomach feeling uncomfortable
passing urine uncontrollably
accidents (patients may be more prone to falls and
Uncommon side effects (affects 1 to 10 users in
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 or pharmacist. This
includes any side effects not listed in this leaflet.
You can also report side effects directly via: Yellow Card Scheme
By reporting side effects you can help provide more information
on the safety of this medicine.
5. How to store Aricept 5mg Tablets
Do not store above 30˚C.
Keep out of the sight and reach of children.
Do NOT use Aricept 5mg Tablets after the expiry date that is
printed on the label. The expiry date refers to the last day of that
If the tablets appear to be discoloured or show any other signs of
deterioration, take them back to your pharmacist who will advise
If your doctor decides to stop the treatment, return any leftover
tablets to the pharmacist. Only keep them if your doctor tells you
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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6. Further Information
What do Aricept 5mg Tablets contain?
Each film-coated tablet contains 5mg of the active ingredient
Other ingredients include lactose monohydrate, maize
starch, microcrystalline cellulose, hydroxypropyl cellulose,
magnesium stearate, talc, macrogol, hypromellose and
titanium dioxide (E171).
What do Aricept 5mg Tablets look like?
Aricept 5mg Tablets are white, round, biconvex, film-coated
tablets embossed with ‘ARICEPT’ on one side and ‘5’ on the
What is in a pack of Aricept 5mg Tablets?
They are available in calendar blister packs of 28 film-coated
Aricept 5mg Tablets are manufactured by: Pfizer S.A.,
Amboise Cedex, France.
Pfizer PGM: Zone Industrielle, 29, Route des Industries,
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 No: 08929/0338
is a registered trademark of Eisai R&D Management
Leaflet revision & issue date (Ref): 17.03.15