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PACKAGE LEAFLET: INFORMATION FOR THE USER

DONEPEZIL HYDROCHLORIDE 5 mg FILM-COATED TABLETS DONEPEZIL HYDROCHLORIDE 10 mg FILM-COATED TABLETS

(donepezil hydrochloride)

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 Hydrochloride 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 Hydrochloride 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

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 such as ibuprofen, or diclofenac sodium (for treatment of pain or arthritis)

•    anticholinergic medicines (e.g. tolterodine).

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.

Donepezil Hydrochloride contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

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

Take your Donepezil Hydrochloride by mouth with a drink of water in the evening before you go to sleep.

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.

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				Date: 30 NOV 2013		Time: 11:51	0
Description	Donepezil 5/10mg 28			No. of colours	1	Page Count	1/2
Component Type	Leaflet	Vendor Job No.	216876	Colours	Black
Affiliate Item Code	302158	Proof No.	4		■■
TrackWise PR No.	NA	Client Market	UK	Non-Print
MA No.	04569/0823 & 0824	Keyline/Drawing No. NA		Colours
Packing Site/Printer	Gerard	Barcode Info	NA	Main Font	Myriad Pro	Body Text Size	10.5pt
Supplier Code	NA	Dimensions	170 x 480mm	This proof represents how this job will image on plate. Please check thoroughly to ensure it meets your requirements as NO liability will be accepted for consequential loss.
Pharma Code	NA
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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 muscle 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 (patients may be more prone to falls and accidental injury).

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 of the 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/bottle after 'EXP.

The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions.

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 contains

The active substance is donepezil hydrochloride. Donepezil Hydrochloride 5 mg Film-Coated Tablet: Each tablet contains 5 mg donepezil hydrochloride (equivalent to 4.56 mg donepezil). Donepezil Hydrochloride 10 mg Film-Coated Tablet: Each tablet contains 10 mg donepezil hydrochloride (equivalent to 9.12 mg donepezil).

The other ingredients are:

Tablet core: lactose monohydrate; maize starch; hydroxypropylcellulose; cellulose, microcrystalline; magnesium stearate.

Tablet coating: hypromellose; titanium dioxide E171; macrogol 400.

What Donepezil Hydrochloride looks like and contents of the pack

Your medicine is in the form of a film-coated tablet. Donepezil Hydrochloride 5 mg Film-Coated Tablets are white, film coated, round tablets embossed with "DL" over "5" on one side and "G" on the reverse. Donepezil Hydrochloride 10 mg Film-Coated Tablets are white, film coated, round tablets, embossed with "DL" over "10" on one side and "G" on the reverse. Donepezil Hydrochloride 5 mg Film-Coated Tablets are available in blisters containing 7, 10, 28, 30, 56, 60, 84, 98, 100 film-coated tablets, calendar packs of 28 and 98 and blister unit dose of 50 x 1.

Donepezil Hydrochloride 5 mg Film-Coated Tablets are also available in bottles containing 100 and 250 film-coated tablets. Donepezil Hydrochloride 10 mg Film-Coated Tablets are available in blisters containing 10, 28, 30, 56, 60, 84, 98, 100 Film-Coated Tablets, calendar packs of 28 and 98 and blister unit dose 50 x 1. Donepezil Hydrochloride 10 mg Film-Coated Tablets are also available in bottles containing 100 and 250 film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.

Manufacturers

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

Generics [UK] Ltd, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.

This leaflet was last revised in: 11/2013

				Date: 30 NOV 2013		Time: 11:51	0
Description	Donepezil 5/10mg 28			No. of colours	1	Page Count	2/2
Component Type	Leaflet	Vendor Job No.	216876	Colours	Black
Affiliate Item Code	302158	Proof No.	4		■■
TrackWise PR No.	NA	Client Market	UK	Non-Print
MA No.	04569/0823 & 0824	Keyline/Drawing No. NA		Colours
Packing Site/Printer	Gerard	Barcode Info	NA	Main Font	Myriad Pro	Body Text Size	10.5pt
Supplier Code	NA	Dimensions	170 x 480mm	This proof represents how this job will image on plate. Please check thoroughly to ensure it meets your requirements as NO liability will be accepted for consequential loss.
Pharma Code	NA
Sign-offs