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DONEPEZIL HYDROCHLORIDE 10MG FILM COATED TABLETS

Active substance: DONEPEZIL HYDROCHLORIDE

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PIL-719UK_DON_V1.qxp

21/11/2012

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Donepezil hydrochloride 5mg film-coated tablets
Donepezil hydrochloride 10mg film-coated tablets
(Donepezil Hydrochloride)
Read all of this leaflet carefully before you start using 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 belongs to a group of medicines called
acetylcholinesterase inhibitors. It is used to treat the symptoms
of dementia (disorder of rational behaviour) in people diagnosed
as having mild to moderately severe Alzheimer's disease (a
chronic mental disease). It is for use only in adult patients.
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 the tablets.
Take special care with Donepezil hydrochloride
• if you have ever had stomach or duodenal ulcers
• if you have ever had a seizure
• if you have a heart condition
• if you have asthma (dyspnoea) or other long term lung
disease
• if you have ever had any liver problems or hepatitis
(inflammation of the liver)
• if you have difficulty passing urine.

Taking Donepezil hydrochloride with food and drink
Donepezil hydrochloride should be taken with liquid (a glass of
water). Food does not have any effect on this medication.
Alcohol consumption should be restricted when taking
donepezil, as alcohol may reduce the levels of donepezil.
Pregnancy and breast-feeding
If you are pregnant, think you might be pregnant or are breast
feeding, do not use Donepezil hydrochloride.
Ask your doctor or your pharmacist 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 fatigue, dizziness and muscle cramps and
if affected 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 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 your
pharmacist if you are not sure.
Take your Donepezil hydrochloride tablet by mouth with a
drink of water at night before you go to bed.

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.
This especially applies to:
• medicines to treat pain and inflammation such as NSAIDs
• antibiotics such as erythromycin and rifampicin
• anti-fungal medicines (medicines destroying or inhibiting
the growth of fungi) such as ketoconazole and itraconazole
• muscle relaxants such as succinylcholine
• anti-depressants (medicines against mental depressions)
such as fluoxetine
• anticonvulsants (medicines used in prevention of the
occurrence of several types of seizures) such as phenytoin
and carbamazepine
• medication for heart condition or high blood pressure such
as quinidine
• other medicines that act the same way as donepezil
(such as galantamine or rivastigmine) and
• some medicines for asthma.

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. Usually, you will start by
taking 5 mg every night. After one month, your doctor may tell
you to take 10 mg every night. The maximum recommended
dose is 10 mg each night.

If you are going to have an operation that requires you to
have a general anaesthetic (narcosis) you should tell your
doctor and the anaesthetist that you are taking Donepezil
hydrochloride.

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.

You should 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. 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. If you accidentally
take too many tablets, the following symptoms may appear:
nausea, vomiting, excess production of saliva, sweating, slow
heart beat, low blood pressure, difficulty in breathing, muscle
weakening, faint and fits (body shakes uncontrollably).

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If you forget to take Donepezil hydrochloride
If you forget to take your medicine, but remember to take it
after a short time, take that day’s dose as usual. However, if a
long delay has occurred (e.g. all day), skip that dose and take
the next dose the next day at the usual time and skip the
forgotten dose. Do not take a double dose to make up for a
forgotten tablet.
If you stop taking Donepezil hydrochloride
Do not stop taking the tablets unless told to do so by your
doctor.
If you have any further questions on the use of this product,
ask your doctor or your pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Donepezil hydrochloride can have side
effects, although not everybody gets them.
In most cases these go away without having to stop
treatment. Tell your doctor if you have any of these effects
and if they are too uncomfortable for you.
Patients taking Donepezil hydrochloride have reported the
following side effects:
Serious side effects:
You must tell your doctor immediately if you notice these
serious side effects mentioned.
You may need urgent medical treatment.
• Fever with muscle stiffness, sweating or a lowered level
of consciousness (a disorder called 'Neuroleptic Malignant
Syndrome').
Very common side effects (estimated frequency is more than
1 person out of 10)
• diarrhoea
• nausea
• headache.
Common side effects (estimated frequency is less than
1 person out of 10 but more than 1 out of 100)
• common cold
• abdominal disturbances
• loss of appetite
• rash
• hallucinations
• itching
• agitation
• muscle cramps
• aggressive behaviour
• urinary incontinence
• fainting
• fatigue
• dizziness
• pain
• insomnia (difficulty in sleeping)
• accident
• vomiting.

5. HOW TO STORE DONEPEZIL HYDROCHLORIDE
Keep out of the reach and sight of children.
Do not store above 30°C.
Do not use Donepezil hydrochloride tablets after the expiry
date which is stated on the blisters and the carton after
. 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.
6. FURTHER INFORMATION
What Donepezil hydrochloride contains
The active substance in these tablets is donepezil
hydrochloride.
5mg: Each tablet contains 5 mg of donepezil hydrochloride,
equivalent to 4.56 mg of donepezil free base.
10mg: Each tablet contains 10 mg of donepezil hydrochloride,
equivalent to 9.12 mg of donepezil free base.
The other ingredients are:
Tablet core:
Lactose Monohydrate, Maize starch, Hydroxypropylcellulose,
Cellulose, Microcrystalline, Magnesium Stearate.
Film-coating:
Hypromellose (E464), Titanium dioxide (E171), Propylene
Glycol, Talc.
What Donepezil hydrochloride looks like and contents
of the pack
5mg: White, round film-coated tablets with a diameter of 7.5
mm approximately.
10mg: White, round film-coated tablets with a diameter of 9.3
mm approximately bearing a breakline on one side. The tablet
can be divided into equal halves.
Pack sizes: 28, 56, 98 tablets.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Alet Pharmaceuticals S.A.
26 Aidiniou Str.,
Haidari,
12461Athens,
Greece
Manufacturer:
Specifar S.A.
1, 28 Octovriou str.,
Ag. Varvara
123 51 Athens,
Greece
This leaflet was last prepared in 12/2012.

Uncommon side effects (estimated frequency is less than
1 person out of 100 but more than 1 out of 1000)
• seizures
• abdominal bleeding
• slow heart beat
• stomach and duodenal ulcers
• minor increase in serum concentration of muscle creatinine
kinase.
Rare side effects (estimated frequency is less than 1 person
out of 1000 but more than 1 out of 10000)
• shaking
• liver disorders including hepatitis
• stiffness or uncontrollable movement especially of the face
and tongue but also of the limbs
• sinoatrial block, atrioventricular block.
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 your
pharmacist.

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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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