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PACKAGE LEAFLET: INFORMATION FOR THE USER

Donepezil hydrochloride 5 mg Orodispersible Tablets Donepezil hydrochloride 10 mg Orodispersible Tablets

(Donepezil hydrochloride)

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.

Donepezil hydrochloride Orodispersible Tablets belong to a group of medicines called acetylcholinesterase inhibitors. These increase the levels of a substance in the brain called acetylcholine, which is involved in memory function.

Donepezil hydrochloride Orodispersible Tablets are 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 Orodispersible Tablets are for use in adult patients only.

2. BEFORE YOU TAKE DONEPEZIL HYDROCHLORIDE ORODISPERSIBLE TABLETS_

Do not take donepezil hydrochloride if

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

Take special care with donepezil hydrochoride

Talk to your doctor or pharmacist before taking donepezil hydrochloride if:

•    you have ever had stomach or duodenal ulcers

•    you have ever had seizures (fits) or convulsions

•    you have a heart condition (irregular or very slow heart beat)

•    you have asthma or other long term lung disease

•    you have liver problems or hepatitis (as patients with severe liver disease should not take donepezil hydrochloride)

•    you have difficulties passing urine or mild kidney disease

•    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.

Children and adolescents: Donepezil hydrochloride is not recommended for use in children and adolescents.

Taking other medicines with donepezil hydrochloride

Tell your doctor or pharmacist if you are taking, have recently taken or want to start taking any other medicines, including medicines obtained without a prescription, vitamins, minerals, herbal medicines or dietary supplements. 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:

•    other medicines for Alzheimer's disease such as galantamine

•    pain killers for treatment of arthritis such as aspirin, non-steroidal anti-inflammatory (NSAID) drugs such as ibuprofen or diclofenac sodium

•    anticholinergic medicines such as tolterodine

•    antibiotics such as erythromycin or rifampicin

•    anti-fungal medicines such as ketoconazole

•    anti-depressants such as fluoxetine

•    anticonvulsants such as phenytoin or carbamazepine

•    medication for a heart condition such as quinidine or beta-blockers (propranolol and atenolol)

•    muscle relaxants such as diazepam or succinylcholine.

•    general anaesthetic.

Taking donepezil hydrochloride with food and drink

You can take the tablets with food but they should not be taken with alcohol because alcohol may reduce the effect of this medicine.

Fertility, pregnancy and breast-feeding

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

You must not drive or operate machinery unless your doctor tells you that it is safe to do so.

This medicine can cause tiredness, dizziness and muscle cramp. If you experience any of these effects you must not drive or operate machinery.

Effects of other ingredients (excipients)

This medicine contains sorbitol. If you have been told by your doctor that you have intolerance to some sugars, you should contact your doctor before taking these tablets.

3. HOW TO TAKE DONEPEZIL HYDROCHLORIDE TABLETS

Always take this medicine exactly as your doctor has told you.

You should check with your doctor or pharmacist if you are not sure.

Tell your doctor or pharmacist the name of your caregiver.

Your caregiver will help you to take your medicine as it is prescribed.

Dose

•    Adults (including patients with kidney disease)

The recommended starting dose is 5 mg every night just before you go to bed. After one month, your doctor may tell you to take 10 mg every night.

•    Patients with liver disease

If you have mild to moderate liver disease, your doctor may need to adjust your dose. If you have severe liver problems, you should not take these tablets (see section 2).

Route and/or method of administration

The tablet should be placed on your tongue and allowed to disintegrate before swallowing, with or without water, according to your preference. 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.

Duration of treatment

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. Your doctor may change the dose you are taking depending on the length of time you have been taking the medicine.

If you take more donepezil hydrochloride than you should

Do not exceed the daily dose recommended by your doctor. Contact your doctor or nearest hospital immediately if you take more than you should. Always take the tablets and the carton with you to the hospital so that the doctor knows what has been taken.

If you take too many tablets you may experience the following symptoms: feeling and being sick, drooling, sweating, slow heart rate, low blood pressure (light-headedness or dizziness when standing), breathing problems, losing consciousness, seizures (fits) or convulsions and muscle weakness.

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

If you stop taking donepezil hydrochloride

Do not stop taking the 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 have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, donepezil hydrochloride orodispersible tablets can cause side effects, although not everybody gets them.

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 such as 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 patients 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 patients 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 patients in 1,000)

•    seizures (fits) or convulsions (affects 1 to 10 patients in 1,000)

•    fever with muscle stiffness, sweating or a lowered level of consciousness (a disorder called 'Neuroleptic Malignant Syndrome').

Other side effects:

Tell your doctor if you notice any of these side effects while you are taking donepezil hydrochloride.

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

•    diarrhoea

•    feeling or being sick

•    headaches.

Common side effects (affects 1 to 10 patients in 100):

•    muscle cramp

•    tiredness

•    difficulty in sleeping (insomnia)

•    more prone to the common cold

•    loss of appetite

•    hallucinations (seeing or hearing things that are not really there), agitation, aggressive behaviour

•    fainting, dizziness

•    vomiting, abdominal disturbances

•    rash, itching

•    passing urine uncontrollably

•    pain

•    accidents (patients may be more prone to falls and accidental injury).

Uncommon side effects (affects 1 to 10 patients in 1,000):

•    slow heart beat

•    abnormal blood levels of the substance creatine kinase

•    fits (seizures)

•    stomach ulcers

•    gastrointestinal bleeding.

Rare side effects (affects 1 to 10 patients 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 get 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

ORODISPERSIBLE TABLETS_

Keep this medicine out of the reach and sight of children.

Do not use donepezil hydrochloride orodispersible tablets after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.

Store below 25°C. Store in the original package to protect from moisture and light.

Do not dispose of medicines 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 orodispersible tablets contain

The active substance is donepezil hydrochloride.

Each 5 mg orodispersible tablet contains 5 mg donepezil hydrochloride equivalent to 4.56 mg donepezil.

Each 10 mg orodispersible tablet contains 10 mg donepezil hydrochloride equivalent to 9.12 mg donepezil.

The other ingredients (excipients) are:

Mannitol, Sorbitol (E420), Crospovidone, Silica, colloidal anhydrous. Sodium stearyl fumarate, Saccharin sodium. Peppermint flavour.

What donepezil hydrochloride orodispersible tablets look like and contents of the pack

Orodispersible tablet.

Donepezil hydrochloride 5 mg orodispersible tablets are white to off-white, round, flat-faced beveled-edge tablet with 'DE 5' on one side and V on the other side.

Donepezil hydrochloride 10 mg orodispersible tablets are white to off-white, round, flat-faced beveled-edge tablet with 'DE 10' on one side and '>' on the other side.

The orodispersible tablets are supplied in blister packs of 7,14, 28, 30, 50, 56, 60, 98 or 120 tablets per carton.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Arrow Generics Limited, Unit 2, Eastman Way, Stevenage,

Hertfordshire SG1 4SZ, United Kingdom.

Manufacturer:

Arrow Pharm (Malta) Limited, HF62, Hal Far Industrial Estate,

Hal Far, BBG 3000, Malta.

This leaflet was last revised in November 2012.