DONEPEZIL HYDROCHLORIDE 5MG FILM-COATED TABLETS

Active substance: 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
You and your caregiver should 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:
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5.
6.

What Donepezil hydrochloride is and what it is used for
Before you take Donepezil hydrochloride
How to take Donepezil hydrochloride
Possible side effects
How to store Donepezil hydrochloride
Further information

1. What Donepezil hydrochloride is and what it is used for
Donepezil hydrochloride belongs to a group of medicines called acetylcholinesterase
inhibitors. Donepezil hydrochloride 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. Before you take Donepezil hydrochloride
Do not take Donepezil hydrochloride
? if you are allergic (hypersensitive) to donepezil hydrochloride, or to piperidine derivates
or to 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
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 some time 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:
? otherAlzheimer'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

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antibiotics e.g. erythromycin, rifampicin
antifungal medicines (e.g. ketoconazole and itraconazole)
anti-depressants e.g. fluoxetine
anti-convulsants 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

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 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 during pregnancy.
Donepezil hydrochloride should not be used while breast-feeding.
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 cramps. If you experience any of these
side 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, you should contact your doctor before taking this
medicine.
3. How to take Donepezil hydrochloride
How much Donepezil Hydrochloride should you take?
The usual starting dose is 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 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 take Donepezil hydrochloride exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
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 stop taking Donepezil hydrochloride
Do not stop taking your 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 take more Donepezil hydrochloride than you should
Do not exceed the dose that your doctor has told you to take. 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 overdose include feeling and being sick, drooling, sweating, slow heartbeat,
low blood pressure (light-headedness or dizziness when standing), breathing problems,
losing consciousness and seizures (fits) or convulsions, as well as increasing muscles
weakness, a possible life threatening condition.
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. If you forget to take your medicine for
more than a week, call your doctor before taking any more medicine.

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
Keep out of the reach and sight of children.
Do not use Donepezil hydrochloride after the expiry date which is stated on the blister and
the outer carton after EXP. The first two digits indicate the month and the last four digits
indicate the year. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.

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.
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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)
Fever with muscle stiffness, sweating or a lowered level of consciousness (a disorder
called "Neuroleptic Malignant Syndrome") (affects fewer than 1 user in 10,000).

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

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 is donepezil hydrochloride.
Donepezil hydrochloride 5 mg, film-coated tablets
Each tablet contains 5 mg donepezil hydrochloride, equivalent to 4.56 mg of donepezil.
Donepezil hydrochloride 10 mg, film-coated tablets
Each tablet contains 10 mg donepezil hydrochloride, equivalent to 9.12 mg of donepezil.
?

The other ingredients in the tablet core are lactose monohydrate, microcrystalline
cellulose (E460), maize starch, hydroxypropyl cellulose (E463), magnesium stearate
(E572).
The ingredients in the tablet coating are hypromellose (E464), macrogols, talc, titanium
dioxide (E171) and purified water.

What Donepezil hydrochloride looks like and contents of the pack
Donepezil hydrochloride 5 mg, film-coated tablets
Donepezil hydrochloride 5 mg, film-coated tablets are white to off-white, round filmcoated tablets, debossed with J on one side and 5 on the other side.
Donepezil hydrochloride 10 mg, film-coated tablets
Donepezil hydrochloride 10 mg, film-coated tablets are white to off-white, round filmcoated tablets, debossed with J on one side and 10 on the other side.
The film-coated tablets are available in blisters of 28, 50, 56, 98, 100 film-coated tablets.
Not all pack sizes may be marketed.

Common side effects (affects 1 to 10 users in 100):
? 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 (affects 1 to 10 users in 1,000):
? slow heart beat
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

MarketingAuthorisation Holder and Manufacturer
Marketing Authorisation Holder:
Jubilant Pharmaceuticals nv
Axxes Business Park
Guldensporenpark 22 – Block C
B-9820 Merelbeke
Belgium
Manufacturers:
PSI supply nv
Axxes Business Park
Guldensporenpark 22 – Block C
B-9820 Merelbeke
Belgium
Distributed by:
Aspire Pharma Ltd.
Bellamy House
Winton Road
Petersfield
Hampshire
GU32 3HA
United Kingdom
This leaflet was last revised in December 2012.

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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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