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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 because it contains important information for you.

•    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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor.

This includes any possible side effects not listed in this leaflet.

What is in this leaflet:

1.    What Donepezil Hydrochloride is and what it is used for

2.    What you need to know before you take Donepezil hydrochloride

3.    How to take Donepezil Hydrochloride

4.    Possible side effects

5.    How to store Donepezil Hydrochloride

6.    Contents of the pack and other information

1.    WHAT DoNEpezIL HYDRocHLoRIDE is AND WHAT It is usED FoR

Donepezil Hydrochloride is used for the treatment of dementia. Donepezil Hydrochloride belongs to a group of medicines called acetylcholinesterase inhibitors. It is used to treat the symptoms of mild to moderately severe dementia of the Alzheimer type. Dementia of the Alzheimer type is a disease that alters the way the brain works and is common in the elderly. Symptoms include increase in memory loss, increasing confusion and changes in the way you behave, making it more difficult to carry out normal daily activities. It is for use only in adult patients.

2.    what you need to know before you take donepezil hydrochloride

Do not take Donepezil Hydrochloride:

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Donepezil Hydrochloride if you suffer or have ever suffered from any of the following conditions:

•    a disorder of the heart (especially if you have an irregular heart beat, sick sinus syndrome, or other conditions that affect the rhythm of the heart). Donepezil may slow down your heart rate

•    stomach or duodenal ulcers, or if you are taking non steroidal anti-inflammatory drugs (NSAIDS) (for treatment of pain or arthritis)

•    difficulty in passing urine

•    fits or seizures: donepezil may have the potential to cause fits or seizures. Your doctor will monitor your symptoms

•    asthma or other lung disease

•    liver disease.

Please inform your doctor if you need to have an operation, as the dose of the medication used in anaesthesia may need to be adjusted.

children and adolescents

Children and adolescents under the age of 18 years of age should not take this medicine.

other medicines and Donepezil Hydrochloride

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, in particular if you are taking any of the following:

•    antidepressants (e.g. fluoxetine)

•    quinidine (for heart rhythm disorders)

•    erythromycin (an antibiotic)

•    rifampicin (for treatment of tuberculosis)

•    ketoconazole or itroconazole (antifungal)

•    carbamazepine or phenytoin (for the control of epilepsy)

•    beta blockers (medication for a heart condition)

•    non steroidal anti-inflammatory drugs (for treatment of pain or arthritis).

Donepezil Hydrochloride should not be taken with other medicines that act in the same way i.e. increasing the amount of acetylcholine in the brain by blocking its breakdown by the enzyme acetylcholinesterase (e.g. galantamine). Medicines that reduce the amount of acetylcholine may work less well if taken together with Donepezil Hydrochloride. If you are unsure please speak to your doctor.

Tell your doctor if you need to have an operation as Donepezil Hydrochloride may increase the effect of muscle relaxants used in anaesthesia.

Taking Donepezil Hydrochloride with food, drink and alcohol

Take special care if drinking alcohol whilst taking Donepezil Hydrochloride as alcohol can reduce the effect of Donepezil Hydrochloride.

pregnancy and breast-feeding

If you are pregnant or trying to become pregnant, do not take Donepezil Hydrochloride before speaking to your doctor. Donepezil Hydrochloride should not be used in pregnancy unless clearly necessary. Women taking Donepezil Hydrochloride should not breast feed.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Do not drive or operate machinery if you feel dizzy, sleepy or get muscle cramps while taking Donepezil Hydrochloride. Alzheimer's disease may also impair your ability to drive or operate machinery. You must not perform these activities unless your doctor tells you that it is safe to do so.

3. how to take donepezil hydrochloride

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

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

Adults

The recommended starting dose is 5 mg of donepezil hydrochloride taken once a day for at least one month. Your doctor may increase this to 10 mg of donepezil hydrochloride taken once a day. The maximum recommended daily dose is 10 mg. If you experience an increase in side effects while taking 10 mg each day, tell your doctor or pharmacist.

use in patients with liver and kidney disease

For adults with mild to moderate liver disease, your doctor may need to adjust your dose. No dosage adjustment is required if you have kidney problems.

use in children or adolescents

Donepezil Hydrochloride is only recommended for adults.

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.

Your doctor will advise you on how long you should continue to take your tablets. You will need to see your doctor regularly to review your treatment and assess your symptoms.

If you take more Donepezil Hydrochloride than you should

Do not take more than one tablet each day.

Contact your doctor or nearest hospital casualty department immediately. Take the container and any remaining tablets with you.

If you take more Donepezil Hydrochloride than you should, you might have symptoms such as severe nausea, vomiting, salivation, sweating, slow heartbeat (bradycardia), low blood pressure (hypotension), breathing difficulties (respiratory depression), muscle weakness (collapse) and involuntary contractions of the muscles (convulsions). You could also suffer from an increased muscles weakness which may be a life threatening condition if respiratory muscles are involved.

If you forget to take Donepezil Hydrochloride

If you forgot 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, contact your doctor before taking any more medicine.

if you stop taking Donepezil hydrochloride

When treatment is stopped the beneficial effects of Donepezil Hydrochloride will decrease gradually.

Do not stop taking your tablets without first discussing with your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You must tell your doctor immediately if you notice these serious side effects mentioned. You may need urgent medical treatment.

•    liver problems including hepatitis (inflammation of the liver characterised by dark urine, pale stools, jaundice, feeling sick and fever); this effect is rare (may affect up to 1 in 1,000 people)

•    bleeding and stomach or bowel ulcers; this effect is uncommon (may affect up to 1 in 100 people)

•    fits; this effect is uncommon (may affect up to 1 in 100 people)

•    fever with muscle stiffness, sweating or a lowered level of consciousness (a disorder called "Neuroleptic Malignant Syndrome"); this effect is very rare (may affect up to 1 in 10,000 people).

other side effects include:

Very common (may affect more than 1 in 10 people):

•    diarrhoea

•    feeling sick

•    headache.

common (may affect up to 1 in 10 people):

•    being sick

•    muscle cramps

•    feeling tired

•    insomnia (difficulty sleeping)

•    common cold

•    anorexia (loss of appetite)

•    hallucinations (seeing or hearing things that are not real)

•    unusual dreams including nightmares

•    agitation

•    aggressive behaviour

•    fainting

•    feeling dizzy

•    abdominal pain or discomfort

•    skin rash and itching

•    urinary incontinence

•    pain

•    accidents.

uncommon (may affect up to 1 in 100 people):

•    slow heartbeat

•    an increase in the levels of a substance called creatine kinase in your blood which is involved in metabolism.

Rare (may affect up to 1 in 1,000 people):

•    extrapyramidal symptoms (EPS) which include involuntary movements, tremors and rigidity, body restlessness, muscle contractions and changes in breathing and heart rate

•    changes in heart rhythm.

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

5.    how to store donepezil hydrochloride

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

•    Do not use this medicine after the expiry date, which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

•    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.    contents of the pack and other information

What Donepezil Hydrochloride Tablets contains

•    The active substance is donepezil hydrochloride.

•    Donepezil Hydrochloride 5 mg Orodispersible Tablets: Each tablet contains 5 mg donepezil hydrochloride (equivalent to 4.56 mg donepezil).

•    Donepezil Hydrochloride 10 mg Orodispersible Tablets: Each tablet contains 10 mg donepezil hydrochloride (equivalent to 9.12 mg donepezil).

The other ingredients are mannitol; silica colloidal anhydrous; hydroxypropylcellulose; acesulfame potassium; glycine; sodium starch glycolate (Type A); crospovidone (Type A); microcrystalline cellulose; magnesium stearate.

Donepezil Hydrochloride 10 mg Orodispersible Tablets also contains yellow iron oxide "E172".

What Donepezil Hydrochloride Tablets look like and contents of the pack

Your medicine is in the form of an orodispersible tablet.

Donepezil Hydrochloride 5 mg Orodispersible Tablets are white coloured round flat bevelled edged tablets, debossed with "DL 5" on one side and "M" on the other side.

Donepezil Hydrochloride 10 mg Orodispersible Tablets are yellow coloured round flat bevelled edged tablets, debossed with "DL 10" on one side and "M" on the other side.

Donepezil Hydrochloride 5 mg and 10 mg Orodispersible Tablets are available in cold form foil OPA/Alu/PVC-Alu blisters in packages of*

7.    10, 14, 28, 30, 50, 56, 60, 84, 98, 100, 120and 180 orodispersible tablets.

*Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Mylan, Potters Bar, Hertfordshire, EN6 1TL, UK

Manufacturers:

Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.

Mylan Hungary Kft., H-2900, Komarom,

Mylan utca.1, Hungary.

This leaflet was last revised in    Code No.: MH/DRUGS/25/NKD/89

06/2014    438290

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