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Aricept® 5mg Tablets / Donepezil hydrochloride 5mg

Tablets

Aricept® 10mg Tablets / Donepezil hydrochloride

10mg Tablets

(donepezil hydrochloride)

These products are available in either of the above strengths and names but will be referred to as Aricept Tablets throughout the following patient information leaflet.

Package leaflet: Information for the user

In this leaflet

1.    What Aricept Tablets 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 Tablets

6.    Further information

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

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 are 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 antiinflammatory (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 Tablets 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. 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

How much Aricept Tablets should you take?

Usually, you will start by taking 5 mg (one white tablet) every night. After one month, your doctor may tell you to take 10 mg (one yellow tablet) every night.

Swallow your Aricept Tablets 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 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.

Your blister pack is marked with the days of the week to help you to remember when to take your medicine. A translation of the days of the week are shown below:

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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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 ARICEPT TABLETS

The tablets should not be stored above 30°C.

Keep out of the sight and reach of children.

Do not use after the expiry date shown on the carton label or blister strip. The expiry date refers to the last day of that month.

If your doctor tells you to stop taking the tablets, 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 any other signs of deterioration, you should seek the advice of your pharmacist who will advise you what to do.

Medicine 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 do Aricept Tablets contain?

The active ingredient is donepezil hydrochloride.

Aricept 5mg Tablets contain 5mg donepezil hydrochloride (equivalent to 4.56mg donepezil free base).

Aricept 10mg Tablets contain 10mg donepezil hydrochloride (equivalent to 9.12mg donepezil free base).

The tablets also contain the following inactive ingredients: lactose, maize starch, microcrystalline cellulose, hyprolose, magnesium stearate, talc, macrogol, hypromellose, titanium dioxide (E171). Additionally, the 10mg tablet contains synthetic yellow iron oxide (E172).

What do Aricept Tablets look like?

Aricept 5mg Tablets are white, round bi-convex, film-coated tablets, plain on both sides.

Aricept 10mg Tablets are yellow, round bi-convex, film-coated tablets, plain on both sides.

What is in a pack of Aricept Tablets?

Aricept Tablets are available in calendar pack sizes of 28 and 56 tablets.

Aricept Tablets are manufactured by Pfizer PGM, Zone Industrielle, 29, Route des Industries, 37530 Poce-sur-Cisse, France and are procured from within the EU by the Product Licence holder: Caseview (PL) Limited, 20 Alliance Court, Alliance Road, London W3 0RB and repackaged by OPD Laboratories Ltd, Unit 6 Colonial Way, Watford, Herts WD24 4PR.

PL 13826/1624 Aricept 5mg Tablets PL 13826/1625 Aricept 10mg Tablets

Aricept Tablets Leaflet revision date (ref) 20/03/2015

Aricept is a registered trademark of Eisai Ltd.

To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.