PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ00000LT000

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 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 hydrochloride is and what it is used for

2.    What you need to know before you take Donepezil hydrochloride

3.    How to take Donepezil hydrochloride

4.    Possible side effects

5.    How to store Donepezil hydrochloride

6.    Contents of the pack and other information

ASANDOZ

What Donepezil hydrochloride is and what it is used for

Donepezil hydrochloride 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.

Donepezil hydrochloride 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 hydrochloride film-coated tablets are for use in adult patients only.

What you need to know before you take Donepezil hydrochloride

Do not take this medicine

if you are allergic to

•    donepezil hydrochloride or

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

•    soya, peanut or any of the other ingredients of Donepezil hydrochloride as listed in section 6.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Donepezil hydrochloride film-coated tablets.

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

•    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 pregnant.

Other medicines and Donepezil Hydrochloride

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 sometime in the future if you continue to take Donepezil hydrochloride. This is because these medicines may weaken or strengthen the effects of Donepezil hydrochloride.

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 hydrochloride. This is because your medicine may affect the amount of anaesthetic needed.

Donepezil hydrochloride 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 hydrochloride.

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

Donepezil hydrochloride with food,drink and alcohol

Food will not influence the effect of Donepezil hydrochloride film-coated tablets. Donepezil hydrochloride film-coated tablets should not be taken with alcohol because alcohol may change their effect.

Pregnancy, breast-feeding and fertility

Donepezil hydrochloride 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.

Donepezil hydrochloride tablets contains lactose and maize starch

Donepezil hydrochloride contains lactose and maize starch (source of glucose).

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

How to take Donepezil hydrochloride

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 Hydrochloride 5 mg Film-coated Tablets:

•    Starting dose: 1 film-coated tablet every night

•    After one month: possible increase to 2 film-coated tablets every night.

•    Maximum dose: 2 film-coated tablets every night

Donepezil Hydrochloride 10 mg Film-coated Tablets:

•    Starting dose: V film-coated tablet every night

•    After one month: possible increase to 1 film-coated tablet every night.

•    Maximum dose: 1 film-coated 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.

Continued on the next page >>

a> ro -d ™ £

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

Patients with severe liver dysfunction

Your doctor will decide if Donepezil hydrochloride is

suitable for you.

Method of administration

Take your film-coated tablets at night before you go to bed, independently from meals. Swallow the film-coated tablets with a glass of water.

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 hydrochloride 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 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 hydrochloride

If you forget to take a film-coated tablet, just take one film-coated 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.

not really there)

•    unusual dreams and nightmares

•    agitation

•    aggressive behaviour

•    fainting

•    dizziness

•    stomach feeling uncomfortable

•    rash

•    itching

•    passing urine uncontrollably

•    pain

•    accident (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

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: 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 hydrochloride

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.

If you stop taking Donepezil hydrochloride

Do not stop taking this medicine 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.

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

Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

4 Possible side effects

Contents of the pack and other information

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 hydrochloride. Tell your doctor if you have any of these effects while you are taking Donepezil hydrochloride.

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 (a disorder called "Neuroleptic Malignant Syndrome") (affects less than 1 user in 10,000).

•    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).

Reported side effects listed according to the frequencies are:

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

•    diarrhoea

•    nausea

•    headache

Common, may affect 1 to 10 users in 100:

•    muscle cramp

•    tiredness

•    difficulty in sleeping (insomnia)

•    the common cold

•    loss of appetite

•    hallucinations (seeing or hearing things that are

What Donepezil hydrochloride contains

The active substance is donepezil hydrochloride. Each film-coated tablet contains 5 mg of donepezil hydrochloride.

Each film-coated tablet contains 10 mg of donepezil hydrochloride.

The other ingredients are:

Tablet core:

Microcrystalline cellulose, Lactose monohydrate, Maize starch, Magnesium stearate

Tablet coat:

5 mg: Polyvinyl alcohol, Talc, Titanium dioxide (E171), Macrogol 3350, Soya lecithin

10 mg: Polyvinyl alcohol, Talc, Titanium dioxide (E171), Macrogol 3350, Soya lecithin, Iron oxide yellow (E172)

What Donepezil hydrochloride looks like and contents of the pack

Donepezil Hydrochloride 5 mg Film-coated Tablets are white and round (diameter 7 mm).

Donepezil Hydrochloride 10 mg Film-coated Tablets are yellow and round (diameter 9 mm) with score line. They can be divided into equal doses.

Donepezil hydrochloride film-coated tablets are available in

•    blisters

Pack sizes of 7, 10, 14, 28, 30, 50, 56, 60, 84, 90, 98, 100, 100 x 1 or 120 film-coated tablets

•    plastic bottles with a screw cap

Pack sizes of 100 or 250 film-coated 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

Salutas Pharma GmbH, Otto-von-Guericke-Allee 1 39179 Barleben, Germany. or Salutas Pharma GmbH, Dieselstrasse 5, 70839 Gerlingen, Germany. or Lek Pharmaceuticals d.d. Verovskova 57, 1526 Ljubljana, Slovenia. or LEK S.A. ul. Domaniewska 50 C, 02-672 Warsaw Poland. or Sandoz S.R.L. Str. Livezeni nr. 7A, 540472 Targu-Mures, Romania.

This leaflet was last revised in 10/201 5.    ^00000000

a> ro -d ™ £