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PACKAGE LEAFLET: INFORMATION FOR THE USER

DONEPEZIL

HYDROCHLORIDE 5MG AND 10MG FILM-COATED TABLETS

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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What donepezil is and what it is used for

2.    What you need to know before you take donepezil

3.    How to take donepezil

4.    Possible side effects

5.    How to store donepezil

6.    Contents of the pack and other information

1. What donepezil is and what it is used for

The name of your medicine is Donepezil hydrochloride 5mg and 10mg film-coated tablets (called donepezil throughout this leaflet).

Donepezil (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 breakdown 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.

Donepezil is for use in adult patients only.

. What you need to know before you take donepezil

Do not take donepezil:

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

•    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 donepezil. This is because your medicine may affect the amount of anaesthetic needed.

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

Donepezil with food, drink and alcohol

Food will not influence the effect of donepezil. Donepezil should not be taken with alcohol because alcohol may change its effect.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Donepezil should not be used while breastfeeding.

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.

Donepezil contains lactose.

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

3. How to take donepezil

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

How much donepezil you should take

Usually, you will start by taking 5mg every night before you go to bed. After one month, your doctor may tell you to take 10mg every 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.

Do not alter the dose yourself without your doctor’s advice.

Warnings and precautions

Talk to your doctor or pharmacist before taking donepezil mainly if you have or have had:

•    stomach or duodenal ulcers.

•    seizures (fits) or convulsions.

•    a heart condition (irregular or very slow heart beat).

•    asthma or other long term lung disease.

•    liver problems or hepatitis.

•    difficulty passing urine or mild kidney disease.

•    any involuntary or abnormal movements of the tongue, face or body (extrapyramidal symptoms). Donepezil may induce or exacerbate extrapyramidal symptoms.

Other medicines and donepezil

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because these medicines may weaken or strengthen the effects of donepezil, e.g.

•    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).

Donepezil 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, your dose may need to be adjusted to your needs by your doctor. Patients with severe liver disease should not take donepezil.

Use in children and adolescents

This medicine is not recommended for use in children and adolescents (younger than 18 years of age).

Taking your medicine

Oral use.

Swallow your donepezil tablet with a drink of water before you go to bed at night.

For how long should you take donepezil

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 take more donepezil than you should

Do not take more than your recommended dose 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.

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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 donepezil

If you forget to take a dose, just take your recommended dose the following day at the usual time. Do not take a double dose to make up for a forgotten dose.

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

Do not stop taking the tablets unless told to do so by your doctor. If you stop taking donepezil, 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, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported by people taking donepezil .

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 (may affect up to 1 in 1,000 people).

•    Stomach or duodenal ulcers. The symptoms of ulcers are stomach pain and discomfort (indigestion) felt between the navel and the breast bone (may affect up to 1 in 100 people).

•    Bleeding in the stomach or intestines. This may cause you to pass black tar like stools or visible blood from the rectum (may affect up to 1 in 100 people).

•    Seizures (fits) or convulsions (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” (may affect up to 1 in 10,000 people).

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

•    Diarrhoea, feeling sick

•    Headache

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

•    Common cold.

•    Loss of appetite.

•    Hallucinations (seeing or hearing things that are not really there), agitation, aggressive behaviour, abnormal dreams and nightmares.

•    Fainting, dizziness, difficulty in sleeping (insomnia).

•    Vomiting, stomach feeling uncomfortable.

•    Rash, itching.

•    Muscle cramps.

•    Passing urine uncontrollably.

•    Tiredness, pain.

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

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

•    Slow heartbeat.

•    Minor changes in some enzyme concentrations.

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

•    Stiffness, shaking or uncontrollable movement especially of the face and tongue but also of the limbs.

•    Irregular heartbeat.

Reporting of side effects

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

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 tablets contain

•    The active substance is donepezil hydrochloride. Each film-coated tablet contains 5mg or 10mg donepezil hydrochloride, equivalent to 4.56mg or 9.12mg of donepezil

•    The other ingredients are lactose monohydrate, microcrystalline cellulose, magnesium stearate, acesulfame potassium, hypromellose, talc, macrogol, and titanium dioxide (E171).

•    Additionally, the 10mg tablet contains synthetic yellow iron oxide (E172).

What donepezil tablets look like and contents of the pack

•    Donepezil 5mg are off white round biconvex film coated tablets of diameter approximately 6.7mm, debossed with “5” on one side and plain on the other side.

•    Donepezil 10mg are yellow coloured round biconvex film coated tablets of diameter approximately 8.8mm, debossed with “10” on one side and break line on the other side. The tablet can be divided into equal doses.

Blister (Oriented Polyamide/Alu/PVC/Alu)

Pack sizes: 7, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100, 112, 120 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Manufacturer

Zentiva, k.s, U kabelovny 130, Dolni Mecholupy, 102 37 Praha 10, Czech Republic

This leaflet was last revised in September 2014

‘Zentiva’ is a registered trademark. © 2014 Zentiva

5. How to store donepezil

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

Do not use this medicine after the expiry date that is printed on the label (EXP). The expiry date refers to the last day of that month.

2    ZV/532 73

Master for leaflet print UNIVERSAL 160x400 mm - prekladany

Size:    160/400 mm

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Optical code: design and location according artwork text on the both sides of the leaflet

backside without optical and look codes

ZeiMTIVA

A SANOFI COMPANY

PM CODE:    ZV/532 73

HV _CODE:    11007008_0003, 11007009_0003

_PR_ODU_CT NA_ME: DONEPEZIL HYDROCHLORIDE spol. tbl.

TYP OF PACKAGING: LEAFLET ARTWORK VERSION: V4 ARTWORK CREATION DATE: 4.9.2014 PLANT NAME:    PRAGUE PHARMA

ARTWORK BY:    L.Hindova