PACKAGE LEAFLET: INFORMATION FOR THE USER

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Donepezil 5 mg Orodispersible Tablets Donepezil 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, pharmacist or nurse.

•    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, pharmacist or nurse. 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

A SANDOZ

IWhat Donepezil is and what it is used for

Donepezil 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.

doctor first if you have kidney or liver disease. Patients with severe liver disease should not take Donepezil. 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 and drink

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

Donepezil is used to treat the symptoms of dementia in people diagnosed as having mild to 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.

2 What you need to know before you take Donepezil

Do not take Donepezil if you are allergic to

•    donepezil hydrochloride or

•    piperidine derivatives, which are similar substances to donepezil, or

•    any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Donepezil. If any of the following concerns you, you or your caregiver should inform your doctor or pharmacist.

•    stomach or duodenal ulcers

•    seizures (fits) or convulsions (Donepezil may have the potential to cause seizures)

•    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 Also tell your doctor if you are pregnant or think you might be.

Other medicines and Donepezil

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that your doctor has not prescribed for you but which you have bought yourself from a chemist/ pharmacist. It also applies to medicines you may take some time in the future if you continue to take Donepezil. This is because these medicines may weaken or strengthen the effects of Donepezil.

Especially tell your doctor if you are taking any of the following types of medicines:

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

•    pain killers or treatment for arthritis e.g. aspirin, non-steroidal anti-inflammatory (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)

•    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.

Donepezil can be used in patients with kidney disease or mild to moderate liver disease. Tell your

Pregnancy, breast-feeding and fertility

Donepezil should not be used while breastfeeding.

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

Driving and using machines

Alzheimer’s disease may impair your ability to drive or operate machines. Do not perform these activities unless your doctor has confirmed that this is safe. This medicine can cause fatigue, dizziness and muscle cramps particularly during the beginning of therapy and dose increase. If affected you must not drive or operate machines.

Important information about some of the ingredients of Donepezil

Donepezil Orodispersible Tablets contain aspartame, which is a source of phenylalanine. This may be harmful for people with phenylketonuria.

3 How to take Donepezil

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

Adults and elderly patients

Donepezil 5 mg Orodispersible Tablets:

-    Starting dose: 1 orodispersible tablet every night

■    After one month: possible increase to 2 orodispersible tablets every night

■    Maximum dose: 2 orodispersible tablets every night.

Donepezil 10 mg Orodispersible Tablets:

■    Starting dose: 5 mg every night - please note Donepezil 10 mg Orodispersible Tablets can not be used for this dose (Donepezil 5 mg Orodispersible Tablets are available to start treatment)

-    After one month: possible increase to 1 orodispersible tablet every night

-    Maximum dose: 1 orodispersible tablet every night.

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

Patients with kidney dysfunction

You can take the usual dose as described above. No

adjustment is required.

Patients with mild to moderate liver dysfunction Your doctor will check your tolerance to Donepezil before increasing the dose.

Patients with severe liver dysfunction Your doctor will decide if Donepezil is suitable for you. Patients with severe liver disease should not take Donepezil.

Method of administration

Take your orodispersible tablets at night before you go to bed, independently from meals. Place them on your tongue and let them disintegrate before swallowing, with or without water, according to your preference.

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Duration of use

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 10 mg donepezil hydrochloride 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 orodispersible tablets, this leaflet and/or the carton with you to the hospital so that the doctor knows what has been taken.

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.

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.

§ How to store Donepezil

If you forget to take Donepezil

If you forget to take an orodispersible tablet, just take one orodispersible tablet 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.

Keep 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 or on the label of the plastic-bottle. The expiry date refers to the last day of that month.

Do not store above 25°C.

Do not use this medicine after 6 months have elapsed from first opening of the plastic-bottle.

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 to protect the environment.

If you stop taking Donepezil

Do not stop taking the orodispersible tablets unless instructed by your doctor. Positive treatment results may gradually diminish if treatment is stopped.

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

6 Contents of the pack and other information

4 Possible side effects

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

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 (affects 1 to 10 users in 10,000)

•    Stomach or duodenal ulcers. The symptoms of ulcers are stomach pain and discomfort (indigestion) felt between the navel and the breast bone (affects 1 to 10 users in 1,000)

•    bleeding in the stomach or intestines. This may cause you to pass black tar like stools or visible blood from the rectum (affects 1 to 10 users in 1,000)

■    seizures (fits) or convulsions (affects 1 to 10 users in 1,000)

■    fever with muscle stiffness, sweating or a lowered level of consciousness. These are the symptoms of a disorder called “Neuroleptic Malignant Syndrome” (affects less than 1 user in 10,000)

Reported side effects listed according to the frequencies are:

Very common, may affect more than 1 in 10 people:

■    diarrhoea

■    nausea (feeling sick)

■    headache.

Common, may affect up to 1 in 10 people:

•    muscle cramps

■    tiredness

■    difficulty in sleeping (insomnia)

■    the common cold

■    loss of appetite

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

■    unusual dreams and nightmares

■    agitation

■    aggressive behaviour

•    fainting

■    dizziness

■    stomach feeling uncomfortable

■    rash

•    itching

■    passing urine uncontrollably

■    pain

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

Uncommon, may affect up to 1 in 100 people:

■    slow heart beat

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

■    shaking, stiffness or uncontrollable movement especially of the face and tongue but also of the limbs

What Donepezil Orodispersible Tablets contain

The active substance is donepezil hydrochloride.

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

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

The other ingredients are:

Aspartame (E951)

Croscarmellose sodium

Iron oxide yellow (E172) (Donepezil 10 mg

Orodispersible Tablets only)

Magnesium stearate Mannitol (E421)

Microcrystalline cellulose Peppermint flavour Silica, colloidal anhydrous Zinc sulfate monohydrate.

What Donepezil Orodispersible Tablets look like and contents of the pack

Donepezil 5 mg Orodispersible Tablets are white, round, flat with embossment “5” on one side and plain on the other side.

Donepezil 10 mg Orodispersible Tablets are yellow, slightly dotted, round, flat with embossment “10” on one side and plain on the other side.

Donepezil Orodispersible Tablets are available in

■    blisters:

Pack sizes of 7, 10, 14, 28, 30, 50, 56, 60, 84, 90, 98 or 120 orodispersible tablets

■    plastic-bottles with a plastic screw cap:

Pack size of 100 orodispersible tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sandoz Ltd, Frimley Business Park, Frimley,

Camberley, Surrey, GU16 7SR, UK.

Manufacturer

LEK S.A, ul. Podlipie 16, 95-010 Strykow, Poland or

LEK S.A, ul. Domaniewska 50 C, 02-672 Warszawa, Poland or

Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany

This leaflet was last revised in 04/2014.

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