Package leaflet: Information for the user

Donepezil hydrochloride 5 mg film-coated tablets Donepezil hydrochloride 10 mg film-coated tablets

Donepezil hydrochloride

Read all of this leaflet carefully before you start taking Donepezil tablets with food, drink and alcohol this medicine because it contains important information You must avoid drinking alcohol while you are being for you treated with donepezil, because it could reduce the effect

-    Keep this leaflet. You may need to read it again. of donepezil.

-    If you have any further questions, ask your doctor or

pharmacist. Pregnancy and breast-feeding

-    This medicine has been prescribed for you only. Ask your doctor or pharmacist for advice before taking Do not pass it on to others. It may harm them, even any medicine.

if their signs of illness are the same as yours. Please contact your doctor as soon as possible if you are

-    If you get any side effects, talk to your doctor or pregnant or think you might be pregnant. Donepezil pharmacist. This includes any possible side effects tablets must not be used during pregnancy.

not listed in this leaflet. Please contact your doctor if you are breast-feeding.

-    The full name of the product is Donepezil Donepezil tablets should not be used by breast-feeding hydrochloride 5 mg and 10 mg film-coated Tablets women.

but it will be referred to as Donepezil tablets in the

rest of the leaflet. Driving and using machines

Donepezil tablets and the disease may impair your ability

What is in this leaflet: to drive or operate machinery. The medicine can cause

1.    What Donepezil tablets are and what they are used for fatigue, dizziness and muscle cramp especially in the

2.    What you need to know before you take Donepezil beginning of treatment, and if affected you must not drive tablets or operate machinery. You should discuss this with your

3.    How to take Donepezil tablets doctor before performing these activities.

4.    Possible side effects

5.    How to store Donepezil tablets Donepezil tablets contain lactose

6.    Contents of the pack and other Information If you have been told by your doctor that you have an

intolerance to some sugars, contact your doctor before

1.    What Donepezil tablets are and what taking this medicinal product. they are used for

3. How to take Donepezil tablets

Donepezil tablets belong to a group of medicines called

acetylcholinesterase inhibitors. It is used to treat the Always take this medicine exactly as your doctor has told symptoms of dementia in people diagnosed as having you. Check with your doctor or pharmacist if you are not mild to moderately severe Alzheimer's disease. Donepezil sure. tablets are for use in adult patients only.

The tablet strength you will take may change depending

2.    What you need to know before you take on the length of time you have been taking the medicine Donepezil tablets and on what your doctor will recommend. The maximum

recommended dose is 10 mg each night.

Do not take Donepezil tablets

•    ifyou are allergic (hypersensitive) to donepezil Usually, you will start by taking 5 mg every night. After hydrochloride, or to piperidine derivatives, or any of the one month, your doctor may tell you to take 10 mg every other ingredients of Donepezil tablets night.

•    ifyou are pregnant

Take Donepezil tablets by mouth with a drink of water at Warnings and precautions night before you go to bed.

Treatment with Donepezil tablets should only be started

and supervised by a doctor with experience in diagnosing No dosage adjustment is required ifyou have kidney and treating Alzheimer's dementia. problems.

Inform your doctor if you: For adults with mild to moderate liver disease, your doctor

•    have ever had stomach or duodenal ulcers, or ifyou are may need to adjust your dose.

taking non steroidal anti-inflammatory drugs (NSAIDS) If you have severe liver problems, you should take extra

•    have ever had a seizure. Donepezil may have the care with Donepezil tablets (see section2“Whatyou need potential to cause fits or seizures. Your doctor will to know beforeyou take Donepezil tablets®). In cases of monitor your symptoms. unexplained liver dysfunction under treatment with

•    have a heart condition (especially ifyou have an donepezil, withdrawal of Donepezil tablets should be irregular heart beat, sick sinus syndrome, or other considered.

conditions that affect the rhythm ofthe heart), as

donepezil may slow down your heart rate. Use in children and adolescents

•    have asthma or other long term lung disease Donepezil is not recommended for children and

•    have ever had liver disease adolescents.

•    have difficulty passing urine

•    are going to have an operation that requiresyou to You should always follow your doctor's advice about how have a general anaesthetic, as the dose of the and when to take your medicine. Do not alter the dose medication used in anaesthesia may need to be yourself without your doctor's advice. Do not stop taking adjusted. the tablets unless told to do so by your doctor.

Other medicines and Donepezil tablets For how long should you take Donepezil tablets

Tell your doctor or pharmacist if you are taking, have Your doctor will advice you on how long you should recently taken or might take any other medicines, continue to take your tablets. You will need to see your including medicines obtained without a prescription. This doctor regularly to review your treatment and assess your is especially important for symptoms.

•    medicines to treat pain and inflammation (NSAID)

•    antibiotics such aserythromycin or rifampicin If you take more Donepezil tablets than you should:

•    anti-fungal medicine, such as ketoconazole or Do not take more tablets than the doctor has told you. itraconazole Contact your doctor or hospital immediately if you take

•    muscle relaxants, such as succinylcholine more than you should. Always take the tablets and the

•    anti-depressants such asfluoxetine carton with you to the hospital so that the doctor knows

•    anticonvulsants,such as phenytoin or carbamazepine what has been taken.

•    medication for a heart condition, such as quinidine, or Symptoms ofoverdose may include nausea,vomiting, high blood pressure, such as beta blockers drooling, sweating,slow heartbeat, difficulty breathing,

•    other medicines that act the same way as donepezil muscle weakness, fainting and seizures.

(such as galantamine or rivastigmine), and some

medicines for diarrhoea, Parkinson's disease or asthma.