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Donepezil Hydrochloride 5 Mg Film Coated Tablets

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Donepezil Hydrochloride 5mg Film-Coated Tablets Donepezil Hydrochloride 10mg Film-Coated Tablets

(Referred to as Donepezil Tablets in the remainder of the leaflet)

Read all of this leaflet carefully before

you start to take this medicine.

- Keep this leaflet. You may need to read it again whilst you are receiving your treatment.

- If you have any further questions, please 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 Donepezil Tablets are and what they are used for

2. Before you take Donepezil Tablets

3. How to take Donepezil Tablets

4. Possible side effects

5. How to store Donepezil Tablets

6. Further information

1. What Donepezil Tablets are and what they are used for

The name of your medicine is Donepezil Tablets.

The active ingredient in your medicine is donepezil hydrochloride. Donepezil hydrochloride belongs to a group of medicines called cholinesterase inhibitors, which are used to treat patients suffering from Alzheimer's dementia (a brain disorder).

Donepezil Tablets are used to treat the symptoms of mild to moderately severe Alzheimer's dementia. They are not a cure.

2. Before you take Donepezil Tablets

You should not take Donepezil Tablets if you:

• are allergic (hypersensitive) to donepezil hydrochloride, piperidine derivatives or to any of the other ingredients in this medicine (see section 6. ‘Further information').

Talk to your doctor before taking Donepezil Tablets if you:

• are due to have an operation and are therefore going to be given an anaesthetic

• have an irregular heart beat caused by ‘heart block' or ‘sick sinus syndrome'

• have a history of stomach ulcers

• are currently taking non steroidal anti-inflammatory drugs (NSAIDs), medicines used to treat pain and high temperature

• have a history of asthma or other breathing problems

• have a movement disorder causing parts of your body to make repetitive, involuntary movements

• are already taking a medicine similar to Donepezil Tablets, for Alzheimer's dementia

• are taking a ‘cholinergic' medicine, used to treat conditions such as muscle weakness and glaucoma (increased pressure in the eyes affecting the vision).

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

The following medicines can affect or can be affected by Donepezil Tablets:

• ketoconazole and itraconazole, used to treat fungal infections

• quinidine, used to treat some heart conditions

• erythromycin and rifampicin, used to treat bacterial infections

• fluoxetine, used to treat depression

• carbamazepine and phenytoin, used to treat fits/seizures

• succinylcholine, used as a muscle relaxant

• beta blockers, used to treat heart conditions.

Taking Donepezil Tablets with food and drink

Alcohol can affect the way Donepezil Tablets work. During treatment with Donepezil Tablets, talk to your doctor before consuming alcoholic drinks.

Pregnancy and breast-feeding

If you are pregnant, check with your doctor before you use Donepezil Tablets. Your doctor will decide if you should take them.

You should not breast-feed if you are taking Donepezil Tablets.

Ask your doctor for advice before taking any medicine.

Driving and using machinery

Donepezil Tablets have minor to moderate effects on the ability to drive and use machinery. However, Alzheimer's dementia itself may affect your ability to drive and use machinery.

When you start the treatment with Donepezil Tablets, or if your doctor has recently increased your dose, you may feel tired, dizzy/light headed or experience muscle cramps. Your doctor will routinely evaluate your ability to drive or use machinery and advise you accordingly.

Important information about some of the ingredients in Donepezil Tablets

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Donepezil Tablets

Always take Donepezil Tablets exactly as your doctor has told you. Your doctor will decide the right dose for you. This will be on the pharmacist's label.

You should take Donepezil Tablets in the evening, just before going to bed. Swallow them whole, with a glass of water.

Adults and elderly

• for the first month of treatment take one Donepezil 5mg Tablet a day. After the first month your doctor will assess your condition and may increase your dose to one Donepezil 10mg Tablet a day.

Children

• Donepezil Tablets are not recommended for use in children.

If you take more Donepezil Tablets than you should

If you or anybody else, including a child, takes too many Donepezil Tablets, contact your nearest hospital casualty department or your doctor immediately. Always take the remaining tablets in the pack and this leaflet with you.

Symptoms of overdose include: feeling very sick, being sick, salivation, sweating, decreased blood pressure (symptoms of which include light headedness), abnormally slow breathing, an abnormally slow heart and pulse rate, fits/seizures and collapse.

Increasing muscle weakness may also be experienced, which can be life threatening if the lungs are affected.

If you forget to take Donepezil Tablets

If you forget a dose, take another as soon as you remember. If it is almost time for your next dose, then do not take the missed dose at all. NEVER take a double dose to make up for the one missed.

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

4. Possible side effects

Like all medicines, Donepezil Tablets can cause side effects, although not everybody gets them.

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The following side effects may be experienced:

Rare (affecting at least 1 in 10000 but less than 1 in 1000 patients)

• movement disorder causing parts of the body to make repetitive, involuntary movements

• an irregular heart beat caused by ‘heart block' or ‘sick sinus syndrome'

• hepatitis and other liver problems (symptoms can include yellowing of the skin and whites of the eyes).

Uncommon (affecting at least 1 in 1000 but less than 1 in 100 patients)

• fits/seizures

• slow heart rate

• ulcers in the stomach or intestine

• bleeding in the digestive system

• increased levels of creatinine kinase in muscles (which are detected by blood tests).

Common (affecting at least 1 in 100 but less than 1 in 10 patients)

• common cold

• loss of appetite

• hallucinations

• agitation

• aggressive behaviour

• fainting

• feeling dizzy

• difficulty in sleeping

• being sick

• stomach upset

• skin rashes and itching

• muscle cramps

• urinary incontinence

• feeling tired

• pain

• accident and injury proneness.

Very common (affecting at least 1 in 10 patients)

• diarrhoea

• feeling sick

• headache.

If you develop a fever with muscle stiffness, sweating or a lowered level of consciousness (a disorder called “Neuroleptic Malignant Syndrome”), you must tell your doctor or pharmacist immediately, as urgent medical treatment may be needed.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting systems listed below:

United Kingdom:

Yellow Card Scheme

Website: www.mhra.gov. uk/yellowcard

Ireland:

HPRA Pharmacovigilance,

Earlsfort Terrace, IRL - Dublin 2;

Tel: +353 1 6764971;

Fax: +353 1 6762517;

Website: www.hpra.ie; e-mail: medsafety@hpra.ie

Malta:

ADR Reporting Website:

www.medicinesauthority.gov.mt/adrportal

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Donepezil Tablets

Keep out of the reach and sight of children.

• this medicinal product does not require any special storage conditions

• do not take Donepezil Tablets after the expiry date stated on the packaging. The expiry date refers to the last day of the month.

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 protect the environment.

monohydrate, microcrystalline cellulose, maize starch, hydroxypropylcellulose (E463), magnesium stearate, hypromellose, talc (E553b), polyethylene glycol and titanium dioxide (E171). Donepezil 10mg Tablets also contain yellow iron oxide (E172).

What Donepezil Tablets look like and the contents of the pack

Donepezil 5mg Tablets are white to off white, round, biconvex, film-coated tablets debossed with ‘W' on one side and ‘3II' on the other side.

Donepezil 10mg Tablets are yellow, round, biconvex, film-coated tablets debossed with ‘W' on one side and ‘3I2' on the other side.

Both strengths of tablet are available in tablet containers (HDPE) of 28, 30 or 100 tablets. They are also available in blister packs (PVC/PVDC/aluminium) of 7, 14, 28, 30, 50, 56, 60, 84, 98,112 or 120 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK.

Manufacturer:

CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF, UK.

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK Only)

Please be ready to give the following information:

Product name

Reference

number

Donepezil Hydrochloride 5mg Film-Coated Tablets

PL 29831/0440

Donepezil Hydrochloride 10mg Film-Coated Tablets

PL 29831/0441

This is a service provided by the Royal National Institute of Blind People.

For the Republic of Ireland please call UK +44 1978 669272.

These medicinal products are authorised under the following names, in the following EEA Member States:

Cyprus

Donepezil Hydrochloride Wockhardt 5mg EniKaAuppsva ps AsnTo upsvio biaKia Donepezil Hydrochloride Wockhardt 10mg EniKaAuppsva ps AsnTo upsvio biaKia Ireland

Donepezil Hydrochloride 5mg Film-Coated Tablets Donepezil Hydrochloride 10mg Film-Coated Tablets Malta

Donepezil Hydrochloride 5mg Film-Coated Tablets Donepezil Hydrochloride 10mg Film-Coated Tablets United Kingdom

Donepezil Hydrochloride 5mg Film-Coated Tablets Donepezil Hydrochloride 10mg Film-Coated Tablets

Date of revision: April 2015.

6. Further information

What Donepezil Tablets contain

The active ingredient is donepezil hydrochloride.

Each Donepezil 5 mg Tablet contains 5mg of donepezil hydrochloride.

Each Donepezil 10 mg Tablet contains 10mg of donepezil hydrochloride.

Twockhardt

The other ingredients are: lactose