iMedi.co.uk

Aricept 5mg Tablets

Informations for option: Aricept 5mg Tablets, show other option
Document: leaflet MAH BRAND_PLPI 08929-0338 change

ARICEPT® 5MG TABLETS / DONEPEZIL HYDROCHLORIDE 5MG TABLETS

(donepezil hydrochloride)


PACKAGE LEAFLET: INFORMATION FOR THE USER

Your medicine is available using either of the above names but will be referred to as Aricept 5mg Tablets throughout this leaflet. Also available as 10mg tablets.

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 5mg Tablets is and what it is used for

2.    Before you take Aricept 5mg Tablets

3.    How to take Aricept 5mg Tablets

4.    Possible side effects

5.    How to store Aricept 5mg Tablets

6.    Further information

1. What Aricept 5mg Tablets is and what it is used for

Aricept 5mg 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 5mg Tablets is for use in adult patients only.

2.    Before you take Aricept 5mg Tablets

Do NOT take Aricept 5mg Tablets

■    if you are allergic (hypersensitive) to donepezil hydrochloride, or to piperidine derivatives, or any of the other ingredients of Aricept 5mg Tablets listed in section 6

Take special care with Aricept 5mg Tablets

Tell your doctor or pharmacist before starting to take Aricept 5mg 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 5mg Tablets. This is because these medicines may weaken or strengthen the effects of Aricept 5mg 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, nonsteroidal 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 5mg Tablets. This is because your medicine may affect the amount of anaesthetic needed.

Aricept 5mg 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 5mg 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 5mg Tablets with food and drink

Food will not influence the effect of Aricept 5mg Tablets.

Aricept 5mg Tablets should not be taken with alcohol because alcohol may change its effect.

Pregnancy and breast-feeding

Aricept 5mg Tablets 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 cramp. If you experience any of these effects you must not drive or operate machinery.

Important information about some of the ingredients of Aricept 5mg 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 5mg Tablets.

3. How to take Aricept 5mg Tablets

How much Aricept 5mg Tablets should you take?

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

Swallow your Aricept 5mg Tablet 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 10mg 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.

For how long should you take Aricept 5mg 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 5mg Tablets

Do not stop taking the tablets unless told to do so by your doctor. If you stop taking Aricept 5mg Tablets, the benefits of your treatment will gradually fade away.

If you take more Aricept 5mg 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 5mg 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 5mg Tablets can cause side effects, although not everybody gets them.

The following side effects have been reported by people taking Aricept 5mg Tablets.

Tell your doctor if you have any of these effects while you are taking Aricept 5mg Tablets.

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") (affects less than 1 user in 10,000).

■    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).

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

Reporting of side effects:

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

You can also report side effects directly via: Yellow Card Scheme Website: 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 5mg Tablets

Do not store above 30°C.

Keep out of the sight and reach of children.

Do NOT use Aricept 5mg Tablets after the expiry date that is printed on the label. The expiry date refers to the last day of that month.

If the tablets appear to be discoloured or show any other signs of deterioration, take them back to your pharmacist who will advise you.

If your doctor decides to stop the treatment, return any leftover tablets to the pharmacist. Only keep them if your doctor tells you to.

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 do Aricept 5mg Tablets contain?

■    Each film-coated tablet contains 5mg of the active ingredient donepezil hydrochloride.

■    Other ingredients include lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, talc, macrogol, hypromellose and titanium dioxide (E171).

What do Aricept 5mg Tablets look like?

■    Aricept 5mg Tablets are white, round, biconvex, film-coated tablets embossed with 'ARICEPT' on one side and '5' on the reverse.

What is in a pack of Aricept 5mg Tablets?

They are available in calendar blister packs of 28 film-coated

tablets.

Manufacturer

Aricept 5mg Tablets are manufactured by: Pfizer S.A.,

Amboise Cedex, France.

Or

Pfizer PGM: Zone Industrielle, 29, Route des Industries,

37530 Poce-sur-Cisse, France.

Procured from within the EU and repackaged by: Doncaster

Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

Product Licence holder: BR Lewis Pharmaceuticals Ltd.,

Kirk Sandall, Doncaster, DN3 1QR.

PL No: 08929/0338    POM

ARICEPT® is a registered trademark of Eisai R&D Management Co., Ltd.

Leaflet revision & issue date (Ref): 17.03.15

Page 2 of 2