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Document: leaflet MAH GENERIC_PL 04569-0823 change

• leaflet ASPIRE PHARMA_PL 19156-0047
• leaflet MAH GENERIC_PL 04569-0823
• leaflet MAH GENERIC_PL 10880-0112
• leaflet MAH GENERIC_PL 17780-0332
• leaflet MAH GENERIC_PL 17907-0404
• leaflet MAH GENERIC_PL 19156-0047
• leaflet MAH GENERIC_PL 30306-0246
• leaflet MAH GENERIC_PL 34771-0048
• leaflet MAH GENERIC_PL 40378-0057
• leaflet MAH GENERIC_PL 42930-0003
• leaflet SOVEREIGN MEDICAL_PL 19156-0047

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Package leaflet:

Information for the patient

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 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 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

1.    What Donepezil Hydrochloride is and what it is used for

Donepezil Hydrochloride is used for the treatment of dementia. Donepezil Hydrochloride belongs to a group of medicines called acetylcholinesterase inhibitors.

It is used to treat the symptoms of mild to moderately severe dementia of the Alzheimer type.

Dementia of the Alzheimer type is a disease that alters the way the brain works and is common in the elderly. Symptoms include increase in memory loss, increasing confusion and changes in the way you behave, making it more difficult to carry out normal daily activities. It is for use only in adult patients.

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

Do not take Donepezil Hydrochloride:

•    if you are allergic to donepezil hydrochloride, to piperidine derivatives or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions Talk to your doctor or pharmacist before taking Donepezil Hydrochloride if you suffer or have ever suffered from any of the following conditions:

•    a disorder of the heart (especially if you have an irregular heart beat, sick sinus syndrome, or other conditions that affect the rhythm of the heart). Donepezil Hydrochloride may slow down your heart rate

•    stomach or duodenal ulcers, or if you are taking non-steroidal anti-inflammatory drugs (NSAIDS) (for treatment of pain

or arthritis)

•    difficulty in passing urine

•    fits or seizures. Donepezil Hydrochloride may have the potential to cause fits

or seizures. Your doctor will monitor your symptoms

•    asthma or other lung disease

•    liver disease.

Please inform your doctor if you need to have an operation, as the dose of the medication used in anaesthesia may need to be adjusted.

Children and adolescents

Children and adolescents under the age of 18 years of age should not take this medicine.

Other medicines and Donepezil Hydrochloride

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, in particular if you are taking any of the following:

•    antidepressants (e.g. fluoxetine)

•    quinidine (for heart rhythm disorders)

•    erythromycin (an antibiotic)

•    rifampicin (for treatment of tuberculosis)

•    ketoconazole or itroconazole (antifungal)

•    carbamazepine or phenytoin (for the control of epilepsy)

•    beta blockers (medication for a heart condition)

•    non-steroidal anti-inflammatory drugs such as ibuprofen, or diclofenac sodium (for treatment of pain or arthritis)

•    anticholinergic medicines (e.g. tolterodine).

Donepezil Hydrochloride should not be taken with other medicines that act in the same way i.e. increasing the amount of acetylcholine in the brain by blocking its breakdown by the enzyme acetylcholinesterase (e.g. galantamine). Medicines that reduce the amount of acetylcholine may work less well if taken together with Donepezil Hydrochloride. If you are unsure please speak to your doctor.

Tell your doctor if you need to have an operation as Donepezil Hydrochloride may increase the effect of muscle relaxants used in anaesthesia.

Donepezil Hydrochloride with alcohol

Take special care if drinking alcohol whilst taking Donepezil Hydrochloride as alcohol can reduce the effect of Donepezil Hydrochloride.

Pregnancy and breast-feeding

Donepezil Hydrochloride should not be used while breast-feeding.

If you are pregnant, 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 Do not drive or operate machinery if you feel dizzy, sleepy or get muscle cramps while taking Donepezil Hydrochloride. Alzheimer's disease may also impair your ability to drive or operate machinery. You must not perform these activities unless your doctor tells you that it is safe to do so.

Donepezil Hydrochloride contains lactose

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

3. 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.

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

Adults

The recommended starting dose is 5 mg of Donepezil Hydrochloride taken once a day for at least one month. Your doctor may increase this to 10 mg of Donepezil Hydrochloride taken once a day. The maximum recommended daily dose is 10 mg. If you experience an increase in side effects while taking 10 mg each day, tell your doctor or pharmacist.

Use in patients with liver and kidney disease

For adults with mild to moderate liver disease, your doctor may need to adjust your dose. No dosage adjustment is required if you have kidney problems.

Use in children or adolescents

Donepezil Hydrochloride is only recommended for adults.

Method of administration Take your Donepezil Hydrochloride by mouth with a drink of water in the evening before you go to sleep.

Your doctor will advise you on how long you should continue to take your tablets. You will need to see your doctor regularly to review your treatment and assess your symptoms.

If you take more Donepezil Hydrochloride than you should Do not take more than one tablet each day. Contact your doctor or nearest hospital casualty department immediately. Take the container and any remaining tablets with you.

If you take more Donepezil Hydrochloride than you should, you might have symptoms such as severe nausea, vomiting, salivation, sweating, slow heartbeat (bradycardia), low blood pressure (hypotension), breathing difficulties (respiratory depression), muscle weakness (collapse) and involuntary contractions of the muscles (convulsions). You could also suffer from an increased muscle weakness which may be a life threatening condition if respiratory muscles are involved.

If you forget to take Donepezil Hydrochloride

If you forgot 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, contact your doctor before taking any more medicine.

If you stop taking Donepezil Hydrochloride

When treatment is stopped the beneficial effects of Donepezil Hydrochloride will decrease gradually.

Sign-offs

Do not stop taking your tablets without first discussing with your doctor.

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.

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

•    liver problems including hepatitis (inflammation of the liver characterised by dark urine, pale stools, jaundice, feeling sick and fever); this effect is rare (may affect up to 1 in 1,000 people)

•    severe stomach pain, especially after eating, or blood in your stools, which may be signs of bleeding and stomach or bowel ulcers; this effect is uncommon (may affect up to 1 in 100 people)

•    fits; this effect is uncommon (may affect up to 1 in 100 people)

•    fever with muscle stiffness, sweating or a lowered level of consciousness (a disorder called "Neuroleptic Malignant Syndrome"); this effect is very rare (may affect up to 1 in

10.000    people)

•    changes to your heart beat, such as changes to the rhythm or 'missed' beats, which may be signs of problems with the electrical signals in your heart; these effects are rare (may affect up to 1 in

1.000    people).

Other side effects include:

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

•    diarrhoea

•    feeling sick

•    headache.

Common (may affect up to 1 in 10 people):

•    being sick

•    muscle cramps

•    feeling tired

•    insomnia (difficulty sleeping)

•    common cold

•    anorexia (loss of appetite)

•    hallucinations (seeing or hearing things that are not real)

•    unusual dreams including nightmares

•    agitation

•    aggressive behaviour

•    fainting

•    feeling dizzy

•    abdominal pain or discomfort

•    skin rash and itching

•    urinary incontinence

•    pain

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

Uncommon (may affect up to 1 in 100 people):

•    slow heartbeat

•    an increase in the levels of a substance called creatine kinase in your blood which is involved in metabolism.

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

•    extrapyramidal symptoms (EPS) which include involuntary movements, tremors and rigidity, body restlessness, muscle contractions and changes in breathing and heart rate.

Reporting of side effects If you get any of the 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 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.

5.    How to store Donepezil Hydrochloride

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/bottle 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 Hydrochloride contains

•    The active substance is donepezil hydrochloride.

•    Donepezil Hydrochloride 5 mg Film-coated Tablet: Each tablet contains 5 mg donepezil hydrochloride.

•    Donepezil Hydrochloride 10 mg Film-Coated Tablet: Each tablet contains 10 mg donepezil hydrochloride.

•    The other ingredients are:

Tablet core: lactose monohydrate (see section 2, 'Donepezil Hydrochloride contains lactose'); maize starch; hydroxypropylcellulose; microcrystalline cellulose; magnesium stearate. Tablet coating: hypromellose; titanium dioxide E171; macrogol.

What Donepezil Hydrochloride looks like and contents of the pack

Your medicine is in the form of a film-coated tablet.

Donepezil Hydrochloride 5mg Film-coated Tablets are white, film-coated, round tablets marked with "DL" over "5" on one side and "G" on the reverse.

Donepezil Hydrochloride 10mg Film-coated Tablets are white, film-coated, round tablets, marked with "DL" over "10" on one side and "G" on the reverse.

Donepezil Hydrochloride 5 mg Film-coated Tablets are available in blisters containing

7,    10, 28, 30, 56, 60, 84, 98, 100 film-coated tablets, calendar packs of 28 and 98 and blister unit dose of 50 x 1.

Donepezil Hydrochloride 5 mg Film-coated Tablets are also available in bottles containing 100 and 250 film-coated tablets. Donepezil Hydrochloride 10 mg Film-coated Tablets are available in blisters containing 10, 28, 30, 56, 60, 84, 98,

100 Film-Coated Tablets, calendar packs of 28 and 98 and blister unit dose 50 x 1.

Donepezil Hydrochloride 10 mg Film-coated Tablets are also available in bottles containing 100 and 250 film-coated tablets.

Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom._

Manufacturers:

Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road,

Dublin 13, Ireland.

Generics [UK] Ltd, Potters Bar,

Hertfordshire, EN6 1TL, United Kingdom.

This leaflet was last revised in 09/2015

Sign-offs

v1/May 2015