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DONEPEZIL 10MG ORODISPERSIBLE TABLET
Active substance(s): DONEPEZIL HYDROCHLORIDE / DONEPEZIL HYDROCHLORIDE / DONEPEZIL HYDROCHLORIDE
DONEPEZIL 5 mg Orodispersible Tablets
DONEPEZIL 10 mg Orodispersible Tablets
You and your caregiver should read all of
this leaflet carefully before you start taking
• Keep this leaflet. You may need to read it
• 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
• 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 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
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
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
• asthma or other long term lung disease
• liver problems or hepatitis
• difficulty passing urine or mild kidney
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.
• pain killers or treatment for arthritis e.g.
aspirin, non-steroidal anti-inflammatory
(NSAID) drugs such as ibuprofen, or
• 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,
• medication for a heart condition e.g.
quinidine, beta-blockers (propanolol and
• muscle relaxants e.g. diazepam,
• 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
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 should not be taken with alcohol
because alcohol may change its effect.
Pregnancy and breast-feeding
DONEPEZIL should not be used while
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
3. HOW TO TAKE DONEPEZI
How much DONEPEZIL should you take?
Usually, you will start by taking 5 mg (one
white tablet) every night before you go to bed.
After one month, your doctor may tell you to
take 10 mg (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
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
Do not alter the dose yourself without your
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.
More information can be found on
the back of the leaflet
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
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
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
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
• 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):
• feeling or being sick
Common side effects (affects 1 to 10 users in
• muscle cramp
• difficulty in sleeping (insomnia)
• the common cold
• loss of appetite
• hallucinations (seeing or hearing things that
are not really there)
• unusual dreams including nightmares
• aggressive behaviour
• stomach feeling uncomfortable
• passing urine uncontrollably
• accidents (patients may be more prone to
falls and accidental injury)
Uncommon side effects (affects 1 to 10 users
• 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
that is printed on the label. The expiry date
refers to the last day of that month.
This medicine does not require any special
storage conditions. 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 DONEPEZIL orodispersible tablets
• The active substance is donepezil
hydrochloride. The 5 mg orodispersible
tablet contains 5 mg of donepezil
hydrochloride and the 10 mg orodispersible
tablet contains 10 mg of donepezil
• The other ingredients are mannitol, colloidal
anhydrous silica, k-carrageenan, and
• Additionally, the 10 mg orodispersible tablet
contains synthetic yellow iron oxide (E172).
What do DONEPEZIL orodispersible tablets
look like ?
• 5 mg white orodispersible tablets marked ‘5’
on one side.
• 10 mg yellow orodispersible tablets marked
‘10’ on one side.
What is in a pack of DONEPEZIL?
The orodispersible tablets are supplied in
packs of 7, 14, 28, 30, 50, 56, 60, 98 or 120.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
The Marketing Authorisation Holder is:
DONEPEZIL orodispersible tablets are
manufactured for Eisai Ltd. by:
Eisai Manufacturing Ltd.,
This leaflet was last approved in
©Copyright Eisai Limited
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
5. HOW TO STORE DONEPEZIL
DO NOT use DONEPEZIL after the expiry date
19 OCT 2012 APPROVER SIGNATURE
PACKAGING SUPPLIER N/A - NOT FOR PRODUCTION
SMALLEST FONT: 8PT
Mark any amendments clearly and return proof. Specify changes only, no comments
315 X 135 MM
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.