PACKAGE LEAFLET: INFORMATION FOR THE USER
Donepezil Hydrochloride 5mg Film-Coated Tablets
Donepezil Hydrochloride 10mg Film-Coated Tablets
(Referred to as Donepezil Tablets in the remainder of the leaflet)
Taking Donepezil Tablets with food
and drink
Alcohol can affect the way Donepezil
Tablets work. During treatment with
Donepezil Tablets, talk to your doctor
before consuming alcoholic drinks.
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Neutral code not required on the leaflet artworks.
Read all of this leaflet carefully before
you start to take this medicine.
- Keep this leaflet. You may need to read
it again whilst you are receiving your
treatment.
- If you have any further questions,
please 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 Donepezil Tablets are and what
they are used for
2. Before you take Donepezil Tablets
3. How to take Donepezil Tablets
4. Possible side effects
5. How to store Donepezil Tablets
6. Further information
1. What Donepezil Tablets are and
what they are used for
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The name of your medicine is
Donepezil Tablets.
The active ingredient in your medicine is
donepezil hydrochloride. Donepezil
hydrochloride belongs to a group of
medicines called cholinesterase
inhibitors, which are used to treat
patients suffering from Alzheimer’s
dementia (a brain disorder).
Donepezil Tablets are used to treat the
symptoms of mild to moderately severe
Alzheimer’s dementia. They are not a
cure.
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2. Before you take Donepezil Tablets
You should not take Donepezil Tablets if
you:
• are allergic (hypersensitive) to
donepezil hydrochloride, piperidine
derivatives or to any of the other
ingredients in this medicine (see
section 6. ‘Further information’).
Talk to your doctor before taking
Donepezil Tablets if you:
• are due to have an operation and are
therefore going to be given an
anaesthetic
• have an irregular heart beat caused by
‘heart block’ or ‘sick sinus syndrome’
• have a history of stomach ulcers
• are currently taking non steroidal
anti-inflammatory drugs (NSAIDs),
medicines used to treat pain and high
temperature
• have a history of asthma or other
breathing problems
• have a movement disorder causing
parts of your body to make repetitive,
involuntary movements
• are already taking a medicine similar to
Donepezil Tablets, for Alzheimer’s
dementia
• are taking a ‘cholinergic’ medicine,
used to treat conditions such as
muscle weakness and glaucoma
(increased pressure in the eyes
affecting the vision).
Taking other medicines
Please tell your doctor or pharmacist if
you are taking or have recently taken any
other medicines, including medicines
obtained without a prescription.
The following medicines can affect or can
be affected by Donepezil Tablets:
• ketoconazole and itraconazole, used to
treat fungal infections
• quinidine, used to treat some heart
conditions
• erythromycin and rifampicin, used to
treat bacterial infections
• fluoxetine, used to treat depression
• carbamazepine and phenytoin, used to
treat fits/seizures
• succinylcholine, used as a muscle relaxant
• beta blockers, used to treat heart
conditions.
Pregnancy and breast-feeding
If you are pregnant, check with your
doctor before you use Donepezil Tablets.
Your doctor will decide if you should take
them.
You should not breast-feed if you are
taking Donepezil Tablets.
Ask your doctor for advice before taking
any medicine.
Driving and using machinery
Donepezil Tablets have minor to
moderate effects on the ability to drive
and use machinery. However,
Alzheimer’s dementia itself may affect
your ability to drive and use machinery.
When you start the treatment with
Donepezil Tablets, or if your doctor has
recently increased your dose, you may
feel tired, dizzy/light headed or
experience muscle cramps. Your doctor
will routinely evaluate your ability to drive
or use machinery and advise you
accordingly.
Important information about some of
the ingredients in Donepezil Tablets
This medicine contains lactose. If you
have been told by your doctor that you
have an intolerance to some sugars,
contact your doctor before taking this
medicine.
3. How to take Donepezil Tablets
Always take Donepezil Tablets exactly as
your doctor has told you. Your doctor will
decide the right dose for you. This will be
on the pharmacist’s label.
You should take Donepezil Tablets in the
evening, just before going to bed.
Swallow them whole, with a glass of
water.
Adults and elderly
• for the first month of treatment take
one Donepezil 5mg Tablet a day. After
the first month your doctor will assess
your condition and may increase your
dose to one Donepezil 10mg Tablet a
day.
Children
• Donepezil Tablets are not
recommended for use in children.
If you take more Donepezil Tablets
than you should
If you or anybody else, including a child,
takes too many Donepezil Tablets,
contact your nearest hospital casualty
department or your doctor immediately.
Always take the remaining tablets in the
pack and this leaflet with you.
Symptoms of overdose include: feeling
very sick, being sick, salivation, sweating,
decreased blood pressure (symptoms of
which include light headedness),
abnormally slow breathing, an
abnormally slow heart and pulse rate,
fits/seizures and collapse.
Increasing muscle weakness may also
be experienced, which can be life
threatening if the lungs are affected.
If you forget to take Donepezil Tablets
If you forget a dose, take another as
soon as you remember. If it is almost
time for your next dose, then do not take
the missed dose at all. NEVER take a
double dose to make up for the one
missed.
If you have any further questions on the
use of Donepezil Tablets, ask your doctor
or pharmacist.
4. Possible side effects
Like all medicines, Donepezil Tablets can
cause side effects, although not
everybody gets them.
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Donepezil 5mg/10mg Tablets
Wockhardt UK
FP3592/3593
EOU
(w)128 x (h)420mm
2303
215831
8pt.
Donepezil_Leaflet_105386-2.ai
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 1st PDF sent on - 5TH JULY 2012
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Changes in detail: • Regulatory text change • Introduced new Wockhardt logo
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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 protect the environment.
6. Further information
What Donepezil Tablets contain
The active ingredient is donepezil
hydrochloride.
Each Donepezil 5 mg Tablet contains
5mg of donepezil hydrochloride.
Each Donepezil 10 mg Tablet contains
10mg of donepezil hydrochloride.
The other ingredients are: lactose
monohydrate, microcrystalline cellulose,
maize starch, hydroxypropylcellulose
(E463), magnesium stearate,
hypromellose, talc (E553b), polyethylene
glycol and titanium dioxide (E171).
Donepezil 10mg Tablets also contain
yellow iron oxide (E172).
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This is a service provided by the Royal
National Institute of Blind People.
Leaflet prepared: July 2012.
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These medicinal products are authorised
under the following names, in the
following EEA Member States:
Cyprus
Donepezil Hydrochloride Wockhardt 5mg
Επικαλυμμένα με λεπτό υμένιο δισκία
Donepezil Hydrochloride Wockhardt
10mg Επικαλυμμένα με λεπτό υμένιο
δισκία
France
Donepezil Wockhardt 5mg comprimé
pelliculé
Donepezil Wockhardt 10mg comprimé
pelliculé
Germany
Donepezilhydrochlorid Wockhardt 5mg
Filmtabletten
Donepezilhydrochlorid Wockhardt
10mg Filmtabletten
Greece
Donepezil Hydrochloride Wockhardt 5mg
Επικαλυμμένα με λεπτό υμένιο δισκία
Donepezil Hydrochloride Wockhardt
10mg Επικαλυμμένα με λεπτό υμένιο
δισκία
Ireland
Donepezil Hydrochloride 5mg
Film-Coated Tablets
Donepezil Hydrochloride 10mg
Film-Coated Tablets
Malta
Donepezil Hydrochloride 5mg
Film-Coated Tablets
Donepezil Hydrochloride 10mg
Film-Coated Tablets
Poland
Wockhardt Donepezil Hydrochloride
United Kingdom
Donepezil Hydrochloride 5mg
Film-Coated Tablets
Donepezil Hydrochloride 10mg
Film-Coated Tablets
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For the Republic of Ireland please call
052 6186000.
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Keep out of the reach and sight of
children.
• this medicinal product does not require
any special storage conditions
• do not take Donepezil Tablets after the
expiry date stated on the packaging.
The expiry date refers to the last day of
the month.
Donepezil Hydrochloride
10mg Film-Coated
Tablets
PL 29831/0441
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5. How to store Donepezil Tablets
Donepezil Hydrochloride
5mg Film-Coated
Tablets
PL 29831/0440
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If you experience any side effects not
listed in this leaflet or feel that the
medicine is affecting you badly, tell your
doctor or pharmacist immediately.
Reference
number
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Very common (affecting at least 1 in
10 patients)
• diarrhoea
• feeling sick
• headache.
Product name
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Common (affecting at least 1 in 100
but less than 1 in 10 patients)
• common cold
• loss of appetite
• hallucinations
• agitation
• aggressive behaviour
• fainting
• feeling dizzy
• difficulty in sleeping
• being sick
• stomach upset
• skin rashes and itching
• muscle cramps
• urinary incontinence
• feeling tired
• pain
• accident and injury proneness.
0800 198 5000 (UK Only)
Please be ready to give the following
information:
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Uncommon (affecting at least 1 in
1000 but less than 1 in 100 patients)
• fits/seizures
• slow heart rate
• ulcers in the stomach or intestine
• bleeding in the digestive system
• increased levels of creatinine kinase in
muscles (which are detected by blood
tests).
Other
formats:
To listen to
or request
a copy of
this leaflet
in Braille,
large print
or audio
please call,
free of charge:
105386/2
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Rare (affecting at least 1 in 10000 but
less than 1 in 1000 patients)
• movement disorder causing parts of
the body to make repetitive, involuntary
movements
• an irregular heart beat caused by
‘heart block’ or ‘sick sinus syndrome’
• hepatitis and other liver problems
(symptoms can include yellowing of the
skin and whites of the eyes).
Manufacturer:
CP Pharmaceuticals Ltd, Ash Road
North, Wrexham, LL13 9UF, UK.
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The following side effects may be
experienced:
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What Donepezil Tablets look like and
the contents of the pack
Donepezil 5mg Tablets are white to off
white, round, biconvex, film-coated
tablets debossed with ‘W’ on one side
and ‘3II’ on the other side.
Donepezil 10mg Tablets are yellow,
round, biconvex, film-coated tablets
debossed with ‘W’ on one side and ‘3I2’
on the other side.
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Both strengths of tablet are available in
tablet containers (HDPE) of 28, 30 or 100
tablets. They are also available in blister
packs (PVC/PVDC/aluminium) of 7, 14,
28, 30, 50, 56, 60, 84, 98,112 or 120
tablets. Not all pack sizes may be
marketed.
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Marketing Authorisation Holder:
Wockhardt UK Ltd, Ash Road North,
Wrexham, LL13 9UF, UK.
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