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DONEPEZIL HYDROCHLORIDE 10 MG FILM COATED TABLETS

Active substance(s): DONEPEZIL HYDROCHLORIDE / DONEPEZIL HYDROCHLORIDE / DONEPEZIL HYDROCHLORIDE

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CONSILIENT HEALTH

PACKAGE LEAFLET:
INFORMATION FOR THE PATIENT

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 because it contains
important information for you.
• 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 only. Do
not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.

What is in this leaflet
1. What Donepezil hydrochloride is and what it is
used for
2. What you need to know before you take Donepezil
hydrochloride
3. How to take Donepezil hydrochloride
4. Possible side effects
5. How to store Donepezil hydrochloride
6. Contents of the pack and other 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
breakdown 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. What you need to know before
you take Donepezil hydrochloride

Patients with severe liver disease should not take
Donepezil hydrochloride.

Do not take Donepezil hydrochloride:

In cases of unexplained liver dysfunction, your doctor
may consider to stop treatment with Donepezil
hydrochloride.



if you are allergic to donepezil hydrochloride, to
piperidine derivatives or any of the other ingredients
of this medicine (listed in section 6).

Warnings and precautions
Tell your doctor or pharmacist before taking 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
• any involuntary or abnormal movements of the
tongue, face or body (extrapyramidal symptoms).
Donepezil hydrochloride may induce or exacerbate
extrapyramidal symptoms.
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.







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, betablockers (propranolol and atenolol)
muscle relaxants e.g. diazepam, succinylcholine
general anaesthetic
medicines obtained without a prescription e.g. herbal
remedies

Tell your doctor or pharmacist the name of your
caregiver. Your caregiver will help you to take your
medicine as it is prescribed.



Other medicines and Donepezil hydrochloride
Tell your doctor or pharmacist if you are taking, have
recently taken or might take use any other medicines,
including medicines obtained without a prescription.
It also applies to medicines you may take sometimes
in the future if you continue to take Donepezil
hydrochloride. This is because these medicines
may weaken or strengthen the effects of Donepezil
hydrochloride.

Donepezil hydrochloride with food and drink and
alcohol
Food will not influence the effect 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



Donepezil hydrochloride should not be taken with
alcohol because alcohol may change its effect.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this
medicine.
Donepezil hydrochloride should not be used while
breastfeeding.
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.

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Also, your medicine can cause tiredness, dizziness and
muscle cramp. If you experience any of these effects
you must not drive or operate machinery.
Donepezil hydrochloride contains 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 this medicine exactly as your doctor or
pharmacist has told you. 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.
If you have liver problems, your dose may need to be
adjusted to your needs by your doctor (see section 2
„Warnings and precautions”).

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 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 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 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 dose.

caused by an abnormal muscle breakdown which can • hallucinations (seeing or hearing things that are not
really there)
be life threatening and lead to kidney problems (a
• unusual dreams including nightmares
condition called rhabdomyolysis) (may affect less
If you stop taking Donepezil hydrochloride
• agitation
than 1 in 10,000 people).
Do not stop taking the tablets unless told to do so by
• aggressive behaviour
• liver damage e.g. hepatitis. The symptoms of
your doctor. If you stop taking Donepezil hydrochloride,
• fainting
hepatitis are feeling or being sick, loss of appetite,
the benefits of your treatment will gradually fade away.
• dizziness
feeling generally unwell, fever, itching, yellowing of
• being sick
the
skin
and
eyes,
and
dark
coloured
urine
(may
If you have any further questions on the use of this
• stomach feeling uncomfortable
affect
up
to
1
in
100
people).
medicine, ask your doctor or pharmacist.
• rash
• stomach or duodenal ulcers. The symptoms of ulcers
• itching
are stomach pain and discomfort (indigestion) felt
4. POSSIBLE SIDE EFFECTS
• passing urine uncontrollably
between the navel and the breast bone (may affect
• pain
up to 1 in 100 people).
Like all medicines, this medicine can cause side
• bleeding in the stomach or intestines. This may cause • accidents (patients may be more prone to falls and
effects, although not everybody gets them.
accidental injury)
you to pass black tar like stools or visible blood from
The following side effects have been reported by people
the rectum (may affect up to 1 in 100 people).
Uncommon side effects (may affect up to 1 in 100
• seizures (fits) or convulsions (may affect up to 1 in
taking Donepezil hydrochloride.
people):
100 people).
• slow heart beat
Tell your doctor if you have any of these effects while
Very common side effects (may affect more than • slight increase in serum concentration of a certain
you are taking Donepezil hydrochloride.
muscle enzyme (creatine kinase)
1 in 10 people):
Serious side effects:
• diarrhoea
Rare side effects (may affect up to 1 in 1,000
You must tell your doctor immediately if you notice
• feeling sick (nausea)
people):
these serious side effects mentioned. You may need
• headaches
• stiffness, shaking or uncontrollable movement
urgent medical treatment.
especially of the face and tongue but also of the
Common side effects (may affect up to 1 in 10
• fever with muscle stiffness, sweating or a lowered
limbs
level of consciousness (a disorder called “Neuroleptic people):

disorders of the electrical conduction system of the
• muscle cramp
Malignant Syndrome”) (may affect less than 1 in
heart (sino-atrial block, atrioventricular block)

tiredness
10,000 people).
• difficulty in sleeping (insomnia)
• muscle weakness, tenderness or pain and
Reporting of side effects
particularly, if at the same time, you feel unwell, have • the common cold
If you get any side effects, talk to your doctor or
• loss of appetite
a high temperature or have dark urine. They may be
pharmacist. This includes any possible side effects not
If you forget to take your medicine for more than one
week, call your doctor before taking any more medicine.

listed in this leaflet. You can also report side effects
directly via: Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

5. HOW TO STORE Donepezil
hydrochloride
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date which is
stated on the packaging after EXP. The expiry date
refers to the last day of that month.
This medicine does not require any special storage
conditions.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.

6. Contents of the pack and other
information
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 lactose monohydrate,
cellulose microcrystalline, maize starch,
hydroxypropylcellulose and magnesium stearate in
the tablet core and titanium dioxide (E171),
hypromellose 5cp, macrogol 400, yellow ferric oxide
(E172) – only in 10 mg tablets in the film coating.
What Donepezil hydrochloride looks like and
contents of the pack
5 mg tablets are white to nearly white, rounded,
diameter approx. 7 mm, biconvex, film-coated tablets.
10 mg tablets are yellowish-brown, rounded, diameter
approx. 9 mm, biconvex, film-coated tablets.
Donepezil hydrochloride is available in packs containing
7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98 and 100
film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer:
KRKA, d.d., Novo mesto, Šmarješka cesta 6,
8501 Novo mesto, Slovenia
Distributed by:
Consilient Health (UK) Ltd., No. 1 Church Road,
Richmond upon Thames, Surrey. TW9 2QE
This leaflet was last revised in 06/2017

P0627

Expand Transcript

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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