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DONEPEZIL HYDROCHLORIDE 5 MG FILM COATED TABLETS

Active substance(s): DONEPEZIL HYDROCHLORIDE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER


Donepezil hydrochloride 5 mg
film-coated tablets
Donepezil hydrochloride 10 mg
film-coated tablets
Donepezil hydrochloride
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 gets 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 hydrochloride is and what it is
used for
2. Before you take Donepezil hydrochloride
3. How to take Donepezil hydrochloride
4. Possible side effects
5. How to store Donepezil hydrochloride
6. Further information

1. WHAT Donepezil hydrochloride
IS AND WHAT IT IS USED FOR

Donepezil hydrochloride (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.
Donepezil hydrochloride is for use in adult patients
only.

2. Before you take Donepezil
hydrochloride
Do not take Donepezil hydrochloride
• if

you are allergic (hypersensitive) to donepezil
hydrochloride, or to piperidine derivatives, or any of

the other ingredients of Donepezil hydrochloride
listed in section 6
Take special care with Donepezil hydrochloride
Tell your doctor or pharmacist before starting to take
Donepezil hydrochloride if you have or have had:
• stomach or duodenal ulcers
• seizures (fits) or convulsions
• a heart condition (irregular or very slow heart beat)
• 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.
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 hydrochloride. This is because your
medicine may affect the amount of anaesthetic
needed.
Donepezil hydrochloride 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 hydrochloride.

Tell your doctor or pharmacist the name of your
caregiver. Your caregiver will help you to take your
medicine as it is prescribed.
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 hydrochloride. This is
because these medicines may weaken or strengthen
the effects of Donepezil hydrochloride.
Especially tell your doctor if you are taking any of the
following types of medicines:
• other Alzheimer’s disease medicines, e.g.
galantamine or rivastigmine,
• 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 or
itraconazole
• 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


Taking Donepezil hydrochloride with food and
drink
Food will not influence the effect of Donepezil
hydrochloride.
Donepezil hydrochloride should not be taken with
alcohol because alcohol may change its effect.
Pregnancy and breast-feeding
Donepezil hydrochloride 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 Donepezil hydrochloride
Donepezil hydrochloride tablets contain lactose.
If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor
before taking this medicinal product.

3. How to take Donepezil
hydrochloride




Always take Donepezil hydrochloride exactly as your
doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
How much Donepezil hydrochloride 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 Donepezil hydrochloride 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 advice
about how and when to take your medicine.
Do not alter the dose yourself without your doctor’s
advice.

If you forget to take Donepezil hydrochloride
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.

For how long should you take Donepezil
hydrochloride?
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 forget to take your medicine for more than one
week, call your doctor before taking any more
medicine.

If you take more Donepezil hydrochloride 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 stop taking Donepezil hydrochloride
Do not stop taking the tablets unless told to do so by
your doctor. If you stop taking Donepezil hydrochloride,
the benefits of your treatment will gradually fade
away.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Donepezil hydrochloride can cause
side effects, although not everybody gets them.
The following side effects have been reported by
people taking Donepezil hydrochloride.
Tell your doctor if you have any of these effects while
you are taking Donepezil hydrochloride.

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).



difficulty in sleeping (insomnia)
the common cold
• loss of appetite
• hallucinations (seeing or hearing things that are not
really there)
• 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 heart beat

Very common side effects (affects more than 1 user
in 10):
• diarrhoea
• feeling or being sick
• headaches

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

Common side effects (affects 1 to 10 users in 100):
• muscle cramp
• tiredness

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 Donepezil
hydrochloride



hypromellose 5cp, macrogol 400, yellow ferric oxide
(E172) – only in 10 mg tablets.

Keep out of the reach and sight of children.
This medicinal product does not require any special
storage conditions.
Do not use Donepezil hydrochloride after the expiry
date stated on the packaging. The expiry date refers
to the last day of that month.
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.

What Donepezil hydrochloride looks like and
contents of the pack
Tablets 5 mg are white to nearly white, rounded,
biconvex, film-coated tablets.
Tablets 10 mg are yellowish-brown, rounded,
biconvex, film-coated tablets.
Tablets are packed in blisters with 7, 10, 14, 20, 28,
30, 50, 56, 60, 84, 90, 98 or 100 film-coated tablets
of 5 mg and 7, 10, 14, 20, 28, 30, 50, 56, 60, 84,
90, 98 or 100 film-coated tablets of 10 mg.
Not all pack sizes may be marketed.

6. FURTHER INFORMATION

Marketing Authorisation Holder and
Manufacturer:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501
Novo mesto, Slovenia


What Donepezil hydrochloride contains
• The active substance is donepezil hydrochloride.
Each film-coated tablet contains 5 mg donepezil
hydrochloride (as monohydrate) equivalent to
4.56 mg donepezil.
Each film-coated tablet contains 10 mg donepezil
hydrochloride (as monohydrate) equivalent to
9.12 mg donepezil.
• The other ingredients are: the core: lactose
monohydrate, cellulose microcrystalline, maize
starch, hydroxypropylcellulose, magnesium stearate;
the film-coating: titanium dioxide (E171),

Distributed by:
Consilient Health (UK) Ltd., 500 Chiswick High Road,
London, W4 5RG.

This leaflet was last revised in October 2011
P0139

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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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