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DONEPEZIL HYDROCHLORIDE 5 MG FILM-COATED TABLET

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 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 symptoms are the same as yours.
If you get any side effects gets 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 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DONEPEZIL HYDROCHLORIDE
Do not take Donepezil hydrochloride
- if you are allergic to donepezil hydrochloride,
piperidine derivatives, or any of the other
ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking
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.
Children and adolescents
Donepezil hydrochloride is not recommended for
children and adolescents below the age of 18 years.
Other medicines and Donepezil hydrochloride
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
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
- 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
- anti-depressants e.g. fluoxetine
- anticonvulsants e.g. phenytoin, carbamazepine
- medication for a heart condition e.g. quinidine,

Pantone Reflex Blue

If you forget to take your medicine for more than one
week, call your doctor before taking any more
medicine.
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.

beta-blockers (propanolol and atenolol)
muscle relaxants e.g. diazepam, succinylcholine
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 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.
Donepezil hydrochloride with food and alcohol
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, think you might be pregnant or are
planning to have a baby, ask your doctor or pharmacist
for advice before taking this 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
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 Donepezil
hydrochloride.
-

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
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 (may
affect up to 1 in 1,000 people).
- stomach or duodenal ulcers. The symptoms of
ulcers are stomach pain and discomfort
(indigestion) felt between the navel and the breast
bone (may affect up to 1 in 100 people).
- bleeding in the stomach or intestines. This may
cause you to pass black tar like stools or visible
blood from the rectum (may affect up to 1 in 100
people).
- seizures (fits) or convulsions (may affect up to 1 in
100 people).
- fever with muscle stiffness, sweating or a lowered
level of consciousness (a disorder called
"Neuroleptic Malignant Syndrome") (may affect up
to 1 in 10,000 people).
- Muscle weakness, tenderness or pain and
particularly, if at the same time, you feel unwell,
have a high temperature or have dark urine. They
may be caused by an abnormal muscle breakdown
which can be life threatening and lead to kidney
problems (a condition called rhabdomyolysis)
(affects less than 1 user in 10,000).
Very common side effects (may affect more than 1 in
10 people):
- diarrhoea
- feeling or being sick
- headaches
Common side effects (may affect up to 1 in 10 people):
- muscle cramp
- tiredness
- difficulty in sleeping (insomnia)
- the common cold
- loss of appetite
- hallucinations (seeing or hearing things that are
not really there)
- unusual dreams including nightmares
- 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 (may affect up to 1 in 100
people):
- slow heart beat
Rare side effects (may affect up to 1 in 1,000 people):
- stiffness, shaking or uncontrollable movement
especially of the face and tongue but also of the
limbs
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.
Reporting of side effects
If you get any side effects talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects
directly via www.mhra.gov.uk/yellowcard By reporting
side effects you can help provide more information on
the safety of this medicine.

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.
The recommended dose is
Usually, you will start by taking 5 mg donepezil
hydrochloride every night. After one month, your
doctor may tell you to take 10 mg donepezil
hydrochloride 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 donepezil
hydrochloride 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.
The tablet can be divided into equal doses.
For how long should you take Donepezil
hydrochloride?
Your doctor or pharmacist will adviseyou 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 tablets than you should. 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 tablet.

LOCATION : Indrad
SIZE

COUNTRY : UK

: 160 x 350 mm_Front / Back Side

Keep this medicine out of the sight and reach of
children.

Supersedes A / W No.:
CODE : 8057527-7803

Name

Signature

8057527-7803

By Javeed Mirza at 10:56 am, Oct 01, 2015
DATE : 30-09-2015

SUBSTRATE :
Department

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Donepezil hydrochloride contains
- The active substance is donepezil hydrochloride.
Donepezil hydrochloride 5 mg
Each film-coated tablet contains 5 mg donepezil
hydrochloride, equivalent to 4.56 mg of donepezil.
Donepezil hydrochloride 10 mg
Each film-coated tablet contains 10 mg donepezil
hydrochloride, equivalent to 9.12 mg of donepezil.
- The other ingredients are maize starch, lactose
monohydrate,
microcrystalline
cellulose,
magnesium stearate, in the tablet core, and
hypromellose, macrogol 6000, talc and titanium
dioxide (E171) in the film coating.
Additional in Donepezil hydrochloride 10 mg:
Ferric oxide yellow (E172) and ferric oxide red
(E172)
What Donepezil hydrochloride looks like and
contents of the pack
Donepezil hydrochloride 5 mg
White to off-white coloured, round, biconvex film
coated tablets debossed with ‘5’ on one side and break
line on other side.
Donepezil hydrochloride 10 mg
Peach coloured, round, biconvex film coated tablets
debossed with ‘10’ on one side and break line on other
side.
The tablets are supplied in
white bottles (HDPE) with child resistant closure ,
containing 28, 30, 56 or 98 (2 x 49) film-coated tablets
or in
PVC/Alu Blister, containing 28, 30, 56, or 98
film-coated tablets or in
OPA/Alu/PVC/Alu Blister with 28, 30, 56, or 98
film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Torrent Pharma (UK) Ltd.
Unit 4, Charlwood Court,
County Oak Way
Crawley
West Sussex. RH11 7XA
United Kingdom
Manufacturer
Torrent Pharma (UK) Ltd.
Unit 4, Charlwood Court,
County Oak Way
Crawley
West Sussex. RH11 7XA
United Kingdom
This leaflet was last revised in 09/2015

5. HOW TO STORE DONEPEZIL HYDROCHLORIDE

REMARK : Folding Length 35 mm
Activities

Do not use this medicine after the expiry date which is
stated on the carton, the blister or on the bottle after
EXP. The expiry date refers to the last day of that
month.
This medicinal product does not require any special
storage conditions.
HDPE bottle:
The shelf life after first opening the bottle is 90 days.
Do not throw away any medicines via wastewater or
householdwaste. Ask your pharmacist how to throw
away medicines no longer use. These measures will
help to protect the environment.

Date

Prepared By Pkg.Dev
Reviewed By Pkg.Dev
Reviewed By RA
Approved By CQA

This colour proof is not colour binding. Follow Pantone shade reference for actual colour matching.

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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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