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PATIENT INFORMATION LEAFLET

ARICEPT® 5mg TABLETS/ DONEPEZIL HYDROCHLORIDE 5mg TABLETS ARICEPT® 10mg TABLETS/ DONEPEZIL HYDROCHLORIDE 10mg TABLETS (donepezil hydrochloride)

This medicine is available as any of the above names but will be referred to as Aricept Tablets throughout the following:

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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet

1.    What Aricept T ablets are and what they are used for

2.    Before you take Aricept Tablets

3.    How to take Aricept Tablets

4.    Possible side effects

5.    How to store Aricept T ablets

6.    Further information

1. WHAT ARICEPT TABLETS ARE AND WHAT THEY ARE USED FORl

Aricept Tablets (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.

Aricept Tablets is for use in adult patients only.

2. BEFORE YOU TAKE ARICEPT TABLETS

Do NOT take Aricept Tablets

•    if you are allergic (hypersensitive) to donepezil hydrochloride, or to piperidine derivatives, or any of the other ingredients of Aricept Tablets listed in section 6

Take special care with Aricept Tablets

Tell your doctor or pharmacist before starting to take Aricept Tablets if you have or have had:

•    stomach or duodenal ulcers

•    seizures (fits) or convulsions

•    a heart condition (irregular or very slow heartbeat)

•    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 sometime in the future if you continue to take Aricept Tablets. This is because these medicines may weaken or strengthen the effects of Aricept Tablets.

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, 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 Aricept Tablets. This is because your medicine may affect the amount of anaesthetic needed.

Aricept Tablets 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 Aricept Tablets.

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

Taking Aricept Tablets with food and drink

Food will not influence the effect of Aricept Tablets.

Aricept T ablets should not be taken with alcohol because alcohol may change its effect.

Pregnancy and breast-feeding

Aricept Tablets should not be used while breastfeeding.

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 cramp. If you experience any of these effects you must not drive or operate machinery.

Important information about some of the ingredients of Aricept Tablets

This medicine contains lactose monohydrate. If you have been told by your doctor that you have intolerance to some sugars, you should contact your doctor before taking Aricept Tablets.

3. HOW TO TAKE ARICEPT TABLETS

For how long should you take Aricept Tablets?

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 Aricept Tablets

Do not stop taking the tablets unless told to do so by your doctor. If you stop taking Aricept Tablets, the benefits of your treatment will gradually fade away.

If you take more Aricept Tablets 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 Aricept Tablets

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 one week, call your doctor before taking any more medicine.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Aricept Tablets can cause side effects, although not everybody gets them.

The following side effects have been reported by people taking Aricept Tablets.

Tell your doctor if you have any of these effects while you are taking Aricept Tablets.

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 (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 less than 1 user in 10,000).

Very common side effects (affects more than 1 user in 10):

•    diarrhoea

•    feeling or being sick

•    headaches

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 heartbeat

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

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 ARICEPT TABLETS

•    Do not use after the expiry date printed on the carton label or blister strip.

•    Do not store above 30°C.

•    Keep all medicines out of the sight and reach of children.

•    If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe disposal. Only keep the tablets if your doctor tells you to.

•    If the tablets become discoloured or show signs of any deterioration, you should seek the advice of your pharmacist.

•    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

Your medicine is called Aricept Tablets. Each tablet contains either 5mg or 10mg of the active ingredient donepezil hydrochloride equivalent to 4.56mg and 9.12mg respectively of donepezil freebase.

The 5mg tablets are round, white and coded 'ARICEPT' on one side and '5' on the reverse.

The 10mg tablets are round, yellow and coded 'ARICEPT' on one side and '10' on the reverse.

Aricept Tablets also contain the following inactive ingredients:

5mg    Tablets:    lactose    monohydrate,    magnesium    stearate,    microcrystalline    cellulose,

hydroxypropylcellulose, talc, maize starch, macrogol, hypromellose, titanium dioxide (E171).

10mg    Tablets:    lactose    monohydrate,    magnesium    stearate,    microcrystalline    cellulose,

hydroxypropylcellulose, talc, maize starch, macrogol, hypromellose, titanium dioxide (E171) and yellow iron oxide (E172).

Aricept Tablets are available as calendar blister packs of 28 tablets.

PL No: 15814/0454    Aricept 5mg Tablets / Donepezil hydrochloride 5mg Tablets |POM|

PL No: 15814/0460    Aricept 10mg Tablets / Donepezil hydrochloride 10mg Tablets

This product is manufactured by Pfizer SA, BP 109, 37401 Amboise Cedex, France and is procured from within the EU and repackaged by the Product Licence holder: OPD Laboratories Ltd, Unit 6 Colonial Way, Watford, Herts WD2 4PR.

Leaflet revision and issue date (Ref.) 29/01/2013

Aricept is a registered Trade Mark of Eisai Co. Ltd, Tokyo, Japan.