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PATIENT INFORMATION LEAFLET DONEPEZIL HYDROCHLORIDE 5 & 10 mg FILM-COATED TABLETS

(donepezil hydrochloride)

The name of this medicine is Donepezil Hydrochloride 5 & 10 mg Film-coated Tablets which will be referred to as Donepezil Tablets throughout this leaflet.

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 further questions, please ask your doctor or your 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.

The active ingredient in your medicine is donepezil hydrochloride which belongs to a group of medicines called acetylcholinesterase inhibitors.

It is used to treat the symptoms of dementia in people diagnosed as having mild to moderately severe Alzheimer’s disease. It is for use only in adult patients.

Do not take Donepezil Tablets if you:

•    are allergic (hypersensitive) to donepezil hydrochloride, or to piperidine derivatives, or to any of the other ingredients used in the tablets (these are listed in Section 6, Further Information)

•    are breast-feeding

Take special care with Donepezil Tablets

Before you take Donepezil Tablets you should tell your doctor if you:

•    experience any movement difficulties such as muscle stiffness or uncontrolled movements

•    are going to have an anaesthetic at the hospital or dentist

•    have ever had stomach or duodenal ulcers

•    have ever had a seizure

•    have a heart condition

•    have asthma or other long term lung disease

•    have ever had any severe liver problems. No studies have been done and therefore no information is available on the safe use of Donepezil tablets in patients with severe liver problems.

•    have difficulty passing urine or bladder problems

•    are pregnant, or think you might be pregnant

•    have kidney disease

•    have mild to moderate liver disease.

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. These also include medicines you may take some time in the future if you continue to take Donepezil Tablets.

It is particularly important that you tell your doctor if you are taking any of the following types of medicines as they may decrease or increase the effect of Donepezil Tablets:

•    other Alzheimer’s disease medicines, e.g. galantamine

•    pain killers or treatment for arthritis e.g. aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac sodium

•    anticholinergic medicines, e.g. tolterodine

•    antibiotics e.g. erythromycin, rifampicin

•    anti-fungal medicine e.g. ketoconazole, itraconazole

•    anti-depressants e.g. fluoxetine

•    anticonvulsants e.g. phenytoin, carbamazepine

•    medicaction fora heart condition e.g. quinidine, beta-blockers (propanolol and atenolol)

•    muscle relaxants e.g. diazepam, succinylcholine

•    general anaesthetic

•    medicines obtained without 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 Tablets. This is because your medicine may affect the amount of anaesthetic needed.

If you are in doubt, consult your doctor or pharmacist before taking Donepezil Tablets.

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

It may still be alright for you to take Donepezil Tablets and your doctor will be able to decide what is suitable for you.

Taking your medicine with food and drink

Do not drink alcohol whilst you are taking Donepezil Tablets. Donepezil Tablets should be taken with a drink of water before you go to bed.

Pregnancy and breast-feeding

Do not take Donepezil Tablets if you are pregnant or think that you might be pregnant, unless you doctor has specifically advised you to do so. You should not breast-feed whist you are taking Donepezil Tablets. Ask your doctor or pharmacist for advice before taking any medicine.

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 fatigue, dizziness and muscle cramps and if affected you must not drive or operate machinery.

Important information about some of the ingredients of Donepezil Tablets

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

Dosage

Always take Donepezil Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Adults: Usually, you will start by taking 5 mg (one white tablet) every night.

After one month, your doctor may tell you to take 10 mg (one yellow tablet) every night.

The maximum recommended dose is 10 mg each night.

Children: Donepezil Tablets are not recommended for children.

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Take your Donepezil Tablets by mouth with a drink of water at night before you go to bed.    £

The tablet strength you will take may change depending on the length of time you have been taking the    2

medicine and on what your doctor will recommend.

If you have mild to moderate liver problems, your dose needs to be gradually and carefully adjusted to your needs by your doctor. If you have severe liver problem, you should take extra care with Donepezil tablets (see section 2, before you take Donepezil tablets). If you have an unexplained liver disease, your doctor may decide to stop your treatment with Donepezil tablet completely.

You should always follow your doctors, or pharmacist’s advice about how and when to take your medicine. Do not alter the dose yourself without your doctor’s advice. Do not stop taking the tablets unless told to do so by your doctor.

How long should you take Donepezil Tablets:

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 Tablets than you should:

DO NOT take more than one tablet 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.

Symptoms of an overdose include severe nausea (feeling sick), vomiting (being sick), salivation (drooling), sweating, a slower heart beat, low blood pressure (light-headedness or dizziness when standing), breathing problems, losing consciousness and seizures (fits) or convulsions.

If you forget to take Donepezil Tablets:

If you forget to take a tablet, just take one tablet the following day at the usual time. 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 Tablets:

The beneficial effects of Donepezil Tablets will gradually diminish if you stop taking Donepezil Tablets. You should not stop taking Donepezil Tablets unless your doctor has told you to do so.

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

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

If you get any of the following symptoms after taking these tablets you should contact your doctor or pharmacist immediately:

•    Any sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat

Serious side effects:

You must tell your doctor immediately if you notice these serious side effects mentioned.

You may need urgent medical treatment.

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

The other following serious side effects have also been reported:

•    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 the whites of the eyes, and dark coloured urine (probably affecting fewer than 1 in 1,000)

•    stomach or duodenal ulcers. The symptoms of ulcers are stomach pain and discomfort (indigestion) felt between the naval and the breast bone (probably affecting fewer than 1 in 100)

•    bleeding in the stomach or intestines. This may cause you to pass black tar like stools or visible blood from the rectum (probably affecting fewer than 1 in 100)

•    seizures (fits) or convulsions (probably affecting fewer than 1 in 100)

•    heart block, a disease in the electrical system of the heart Very common side effects (affecting more than 1 in 10)

•    diarrhoea; feeling or being sick; headaches Common side effects (affecting 1 in 10)

•    muscle cramps

•    tiredness; difficulty in sleeping (insomnia)

•    the common cold

•    loss of appetite

•    hallucinations (seeing or hearing things that are not really there)

•    agitation; aggressive behavior • fainting; dizziness

•    stomach feeling uncomfortable • rash; itching

•    passing urine uncontrollably

•    pain

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

Uncommon side effects (affecting fewer than 1 in 100)

•    slow heart beat

Rare side effects (affecting fewer than 1 in 1,000)

•    stiffness, shaking or uncontrollable movements especially of the face and tongue but also of the limbs 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 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.

Keep out of the sight and reach of children.

DO NOT use Donepezil Tablets after the expiry date that is printed on the label. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions. Store in the original package.

If your doctor tells you to stop taking your medicine, you should return any you have not used to your pharmacist.

Do not use if you notice that your tablets are broken or chipped, return them to your pharmacist.

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 to protect the environment.

6. FURTHER INFORMATION

What Donepezil Tablets contain:

Donepezil Tablets contains 5mg or 10mg of the active substance donepezil hydrochloride.

The other ingredients are:

Tablet core:

Lactose monohydrate, Lactose, maize starch, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, & magnesium stearate.

Film-Coatina:

Opadry white which consists of hypromellose, polyethylene glycol and titanium dioxide (E171).

Opadry yellow which consists of hypromellose, polyethylene glycol, iron oxide yellow (E172) and titanium dioxide (E171).

What Donepezil Tablets looks like and contents of the pack:

Donepezil Hydrochloride 5mg Tablets are white, circular, biconvex, film coated tablets with ‘5’ on one side and ‘DPZ’ on the other side.

Donepezil Hydrochloride 10mg Tablets are yellow, circular, biconvex film coated tablets with ‘10’ on one side and ‘DPZ’ on the other side.

This medicine is available in blister packs containing 28 tablets.

Marketing Authorisation Holder:

Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom. Manufacturer:

Cipla (EU) Limited, 4th Floor, 1 Kingdom Street, London, W2 6BY, United Kingdom This leaflet was last revised in May 2014.

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