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DONEPEZIL HYDROCHLORIDE 10 MG ORODISPERSIBLE TABLETS

Active substance(s): DONEPEZIL HYDROCHLORIDE

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Donepezil hydrochloride
Package leaflet:
Information for the user

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

Pharma Code 1885

Donepezil hydrochloride belongs to a
group of medicines called acetylcholine
esterase inhibitors: It increases the levels
of the substance acetylcholine in the brain
involved in memory function by slowing
down the breakdown of acetylcholine.
It is used to relieve the symptoms of mild
to moderately severe Alzheimer’s
dementia. 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.

2

What you need to know before you
take Donepezil Hydrochloride

Remember: You must tell your doctor who
your carers are.
Do not take Donepezil Hydrochloride
• if you are allergic (hypersensitive) to
donepezil hydrochloride or any of the
other ingredients of this medicine (listed
in section 6).
• if you are allergic to other medicines
containing a piperidine derivative
(donepezil is a piperidine derivative).

Donepezil hydrochloride is not
recommended in children and teenagers
under 18 years of age.

Inform your doctor if you are being treated
with any of the following medicines,
because the effect of Donepezil
Hydrochloride or the other medicine could
be influenced if you take the two medicines
together:
• Medicines against fungal infections, such
as ketoconazole or itraconazole
• Pain killers or treatment for arthritis e.g.
aspirin, non-steroidal anti-inflammatory
(NSAID) drugs such as ibuprofen, or
diclofenac sodium
• Anticholinergics medicines, such as
tolterodine
• Antibiotics, such as erythromycin or
rifampicin
• Heart medicines, such as quinidine or
beta-blockers
• Medicines for epilepsy, such as
phenytoin or carbamazepine
• Antidepressants, such as fluoxetine
• Muscle relaxants
• General anaesthetic
• Other medicines that act the same way
as Donepezil Hydrochloride (such as
galantamine or rivastigmine), and some
medicines for diarrhoea, Parkinson's
disease or asthma
• medicines obtained without a
prescription, such as herbal remedies.

Pharma Code 1885

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.
The individual effect of Donepezil
Hydrochloride cannot be predicted,
therefore the effect of the treatment
should be evaluated regularly by a doctor.

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.
Contact your doctor or nearest hospital
immediately if you take too high a dose of
Donepezil Hydrochloride. At a high dose
(overdose), the listed side effects may be
worse (see section 4: Possible side effects).
In particular:
• severe nausea (feeling sick)
• vomiting (being sick)
• drooling
• sweating
• a slow heart beat
• low blood pressure (light-headedness or
dizziness when standing)
• difficulty breathing
• collapse (losing consciousness)
• seizures and muscle weakness may occur.
Always take the tablets and the carton with
you to the hospital so that the doctor
knows what has been taken.

You should not use Donepezil
Hydrochloride if you are pregnant or
breast-feeding.
If you are pregnant or breast-feeding, or
think you might be pregnant or are
planning to have a baby, ask your doctor or
pharmacist for advice before taking this
medicine.

If you forget to take Donepezil
Hydrochloride

Driving and using machines

How to take Donepezil
Hydrochloride

Always take this medicine exactly as your
doctor has told you. Check with your
doctor or pharmacist if you are not sure.
The recommended dose is described
below.
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 will recommend. For
doses not realisable/practicable with this
strength other strengths of this medicinal
product are available.
Dosage
Usually, you will start by taking 5 mg
donepezil hydrochloride (one white tablet)
every night. After one month, your doctor
may tell you to take 10 mg donepezil
hydrochloride (one yellow tablet) every
night. The maximum recommended dose is
10 mg donepezil hydrochloride each night.
Both you and your caregivers should be
aware of the doctor's instructions.

Contact your doctor if you experience the
following side effects:
• hallucinations
• agitation
• aggressive behaviour
• convulsions or brief fainting episodes
as the dose might need to be lowered or
treatment stopped.

Common: may affect up to 1 in 10 people
Dizziness, sleeplessness, tiredness,
fainting, hallucinations, unusual dreams
including nightmares, agitation, aggressive
behaviour, pain, loss of appetite, digestive
disturbances, including vomiting,
incontinence, muscle cramps, rash, itching,
more prone to colds and having accidents.

• The tablet should be placed on the
tongue and allowed to disintegrate
Uncommon: may affect up to 1 in 100
before swallowing with or without water, people
according to your preference.
Slow heart rate, and abnormal levels of the
substance creatine kinase in the blood.
For how long should you take Donepezil

Pregnancy, breast-feeding and fertility

3

3

• Keep your hands dry and take the tablet
out of the strip.

Donepezil Hydrochloride with food and
drink
Food will not influence the effect of
Donepezil Hydrochloride.
You must avoid drinking alcohol while you
are being treated with Donepezil
Hydrochloride, because it could reduce the
effect of Donepezil Hydrochloride.

This medicinal product contains
aspartame, a source of phenylalanine and
may be harmful for people with
phenylketonuria.

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).

1
• Carefully peel off the lidding foil, starting Other side effects:
in the corner indicated by the arrow
Very common: may affect more than 1 in
(Figures 2 and 3)
10 people
Diarrhoea, nausea and headache.

2

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

Alzheimer's disease may impair your
ability to drive or operate machinery. You
should not drive unless your doctor tells
you that it is safe to do so. Also, your
medicine can cause tiredness, dizziness
and muscle cramp and if affected, you
must not drive or operate machinery.

9 February 2016

• Do not push the tablet out of the pocket,
as this will crush it
• Each strip contains tablets separated in
pockets by perforations. Tear off one
tablet pocket along the dotted lines
(Figure 1)

Other medicines and Donepezil
Hydrochloride
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines.

3

Take your tablet by mouth at night before
you go to bed:

Children and adolescents

Warnings and precautions
Talk to your doctor or pharmacist before
taking Donepezil Hydrochloride
Treatment with Donepezil Hydrochloride
should only be started and supervised by a
Donepezil Hydrochloride contains lactose
doctor with experience in diagnosing and
and aspartame
treating Alzheimer’s dementia.
Donepezil Hydrochloride contains lactose.
Inform your doctor if you:
If you have been told by your doctor that
• have ever had a stomach or intestinal
you have an intolerance to some sugars,
ulcer
contact your doctor before taking this
• frequently take pain-killers or treatment
medicinal product.
for rheumatism (pain or inflammation
around bones, joints or muscles): taking
these medicines at the same time as
Donepezil Hydrochloride could put you at
greater risk of developing stomach or
intestinal ulcers.
• have ever had seizures
• have a heart condition (irregular or very
slow heart beat)
• have asthma or other long-term lung
disease
• have difficulties when urinating
• have ever had any liver problems or
hepatitis
• are going to have an operation that
requires you to have a general
anaesthetic. You must inform the
anaesthetist that you are taking
Donepezil Hydrochloride. This is because
your medicine may affect the amount of
anaesthetic needed.
Also tell your doctor if you are pregnant or
think you might be pregnant.

Version:

Pharma Code 1885

DONEPEZIL HYDROCHLORIDE 5 mg
ORODISPERSIBLE TABLETS
DONEPEZIL HYDROCHLORIDE 10 mg
ORODISPERSIBLE TABLETS

231-30-17704-E LEA DONEPEZIL A/S OD TAB TUK
Pharma Code 1885

TEVA UK Ref:

If you forget to take a dose, take it as
quickly as possible after noticing this,
unless it is time for the next dose.
Do not take a double dose to make up for a
forgotten dose. Take your customary dose
on the following day at the usual time.
If you forget to take your medicine for
more than one week, call your doctor
before taking any more medicine.

Rare: may affect up to 1 in 1,000 people
Heart problems like abnormal heart rate, as
well as symptoms such as shaking,
stiffness or uncontrollable movement of
the face and tongue, but also of the limbs.
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 the Yellow Card Scheme at:
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 blister and
carton after EXP. The expiry date refers to
the last day of that month.
This medicinal product 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
Orodispersible Tablets contain

The active substance is donepezil
hydrochloride.
If you stop taking Donepezil Hydrochloride 5 mg: Each orodispersible tablet contains
Do not stop taking the tablets unless told to 5 mg donepezil hydrochloride equivalent to
4.56 mg donepezil.
do so by your doctor. If you stop taking
10 mg: Each orodispersible tablet contains
Donepezil Hydrochloride, the benefits of
10 mg donepezil hydrochloride equivalent
your treatment will gradually fade away.
to 9.12 mg donepezil.
If you have any further questions on the use
The other ingredients are mannitol (E421),
of this medicine, ask your doctor or
hypromellose, silical colloidal anhydrous,
pharmacist.
crospovidone, lactose monohydrate, maize
Possible
side
effects
starch, aspartame (E951), magnesium
4
stearate.
Like all medicines, this medicine can cause 10 mg orodispersible tablet also contains:
iron oxide, yellow.
side effects, although not everybody gets
them.
What 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.

Orodispersible Tablets look like and
contents of the pack

Rare may affect up to 1 in 1,000 people
• 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.

Not all pack sizes may be marketed.

Orodispersible tablet
5 mg: White, flat bevelled edge, round
Uncommon may affect up to 1 in 100 people tablet, engraved with “L 5” on one side
and plain on the other, available in pack
• stomach or duodenal ulcers. The
sizes of 1, 7, 28, 30, 50, 56, 60, 98, 100 or
symptoms of ulcers are stomach pain
and discomfort (indigestion) felt between 120 orodispersible tablets.
10 mg: Yellow, flat bevelled edge, round
the navel and the breast bone.
tablet engraved with “L 10” on one side
• bleeding in the stomach or intestines.
This may cause you to pass black tar like and plain on the other, available in pack
sizes of 1, 7, 28, 30, 50, 56, 60, 98, 100 or
stools or visible blood from the rectum.
120 orodispersible tablets.
• seizures (fits) or convulsions.

Very rare may affect up to 1 in 10,000
people
• fever with muscle stiffness, sweating or a
lowered level of consciousness (a
disorder called "Neuroleptic Malignant
Syndrome").
• muscle weakness, tenderness or pain and

Marketing Authorisation Holder and
Manufacturer
Teva UK Limited, Eastbourne, BN22 9AG
Manufacturer
TEVA Pharmaceutical Works Private Ltd,
Company, Pallagi út 13, 4042 Debrecen,
Hungary
This leaflet was last revised in February 2016
PL 00289/1135
PL 00289/1136

17704-E
20063670

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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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