Document: Donepezil Accord film-coated tablet ENG PL change

• Donepezil Accord film-coated tablet PL
• Donepezil Accord film-coated tablet ENG PL

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Package leaflet: Information for the user

Donepezil Accord 5 mg Film-coated tablets

Donepezil Accord 10 mg Film-coated tablets

donepezilhydrochloride

Read all of this leaflet carefully before you start taking this medicinebecause 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 inthis leaflet

1. What DonepezilAccord is and what it is used for

Donepezil belongs to a group of medicines called acetylcholinesterase inhibitors.

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 only in adult patients.

2. What you need to know before you take DonepezilAccord

Do not take Donepezil Accord

Warnings and precautions

Talk to your doctor or pharmacist before taking Donepezil Accord. In particular, tell your doctor:

• if you have or have had stomach or duodenal ulcers

• if you have or have had seizures (fits) or convulsions

• if you have or have had a heart condition (irregular or very slow heart beat)

• if you have or have had asthma or other long term lung disease

• if you have or have had liver problems or hepatitis

• if you have or have had difficulty passing urine or mild kidney disease

Donepezil Accord 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. Patients with severe liver disease should not take Donepezil Accord.

Other medicines and Donepezil Accord

Tellyour doctor or pharmacist if you are taking,have recently taken or might take any other medicines.

Tell your doctor if you are taking any of the following 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 Accord. This is because your medicine may affect the amount of anaesthetic needed.

Donepezil Accord with food, drink and alcohol

Food will not influence the effect of Donepezil Accord.

Donepezil Accord should not be taken with alcohol because alcohol may change its effect.

Pregnancy, breast-feeding and fertility

Donepezil Accord should not be used during pregnancy unless clearly necessary.

Donepezil Accord 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, askyour doctor or pharmacist for advice before taking thismedicine.

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 Accordcontains lactose

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

3. How to take Donepezil Accord

Always take this medicine exactly as your doctor or pharmacist has told you. Checkwith your doctor or pharmacist if you are not sure.

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.

Swallow your Donepezil Accord with a drink of water before you go to bed at 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.

Always follow your doctor’s, or pharmacist’s advice about how and when to take your medicine.

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

For how long should you take Donepezil Accord?

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 Accord 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 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 Accord

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

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 Accord

Do not stop taking the tablets unless told to do so by your doctor. If you stop taking Donepezil Accord, 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 Accord.

Serious side effects:

You must tell your doctor immediately if you notice these serious side effects mentioned. You may need urgent medical treatment.

• 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)

• 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)

• 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)

• Muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell, have a high temperature or have dark urine. They may be caused by an abnormal muscle breakdown which can be life threatening and lead to kidney problems (a condition called rhabdomyolysis) (may affect up to 1 in 10,000 people).

Other side effects that may occur:

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

• diarrhoea

• feeling sick

• headaches

Common: may affect up to 1 in 10 people:

• muscle cramp

• tiredness

• difficulty in sleeping (insomnia)

• the common cold

• loss of appetite

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

• unusual dreams including nightmares

• agitation

• aggressive behaviour

• fainting

• dizziness

• stomach feeling uncomfortable

• vomiting

• 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

• minor increase in serum concentration of muscle creatine kinase

• seizures (fits)

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

• disturbance in heart rhythm

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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Donepezil Accord

• Keep this medicine 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 after EXP. The expiry date refers to the last day of that month.

• 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 Accord contains

The active substance is donepezil hydrochloride. Each film-coated tablet contains Donepezil hydrochloride monohydrate equivalent to donepezil hydrochloride 5 mg / 10 mg

The other ingredients are:

Core: Lactose monohydrate, maize starch, cellulose microcrystalline, low-substituted hydroxypropyl cellulose, magnesium stearate

Coating:

For 5 mg: Hypromellose (E464), titanium dioxide (E171), macrogol 400, talc (E553b)

For 10 mg: Hypromellose (E464), titanium dioxide (E171), macrogol 400, talc (E553b), iron oxide yellow (E172)

What Donepezil Accordlooks like and contents of the pack

Donepezil Accord is presented as 5 mg, and 10 mg tablets. The tablets are described below.

5 mg: White to off-white, round, approximately 7.14 mm in diameter, bevelled edge, biconvex, film coated tablets with inscription "5" on one side and plain on other side.

10 mg: Yellow, round, approximately 8.73 mm in diameter, biconvex, film coated tablets with inscription "10" on one side and plain on other side.

Donepezil 5 mg / 10 mg Tablets is available in the following pack sizes:

PVC/Alu Blister in outer carton: 7, 28, 30, 50, 56, 60, 84, 98 and 120 tablets

HDPE Bottle: 100 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder :

To be completed nationally

Manufacturer

To be completed nationally

This medicinal product is authorized in the Member States of the EEA under the following names:

Name of the member state	Name of the medicinal product
Bulgaria	Donepezil Hydrochloride Accord 5 mg / 10 mg Филмирани таблетки
Czech Republic	Donepezil Accord 5 mg / 10 mg Potahované tablety
Estonia	Donepezil Accord
Hungary	Donepezil Hydrochloride Accord 5 mg / 10 mg Filmtabletta
Lithuania	Donepezil Accord 5 mg / 10 mg Plėvele dengtos tabletės
Poland	Donepestan
Slovak Republic	Donepezil Accord 5 mg / 10 mg filmom obalené tablety
Slovenia	Donepezilijev klorid Accord 5 mg / 10 mg filmsko obložene tablete
Sweden	Donepezil Accord
Austria	Donepezil Accord 5 mg /10 mg Filmtabletten
Cyprus	Donepezil Accord 5 mg / 10 mg επικαλυμμένα με λεπτό υμένιο δισκία
Denmark	Donepezilhydrochlorid Accord 5 mg / 10 mg filmovertrukne tabletter
Finland	Donepezil Accord 5 mg / 10 mg kalvopäällysteinen tabletti/ filmdragerade tabletter
Ireland	Donepezil 5 mg /10 mg Film-coated Tablets
Italy	Donepezil Accord 5 mg / 10 mg Ccompresse Rvestite Ccon Film
Malta	Donepezil 5 mg / 10 mg Film-coated Tablets
Norway	Donepezil Accord 5 mg / 10 mg Filmdrasjerte tabletter
Portugal	Donepezilo Accord 5 mg /10 mg Comprimidos revestidos por película
United Kingdom	Donepezil Hydrochloride 5 mg / 10 mg Film-coated Tablets

This leaflet was revisedin: 2016-04-21