ITEVA UK Ref: 231-30-13020-G LEA DONEPEZIL A/S TAB TUK XPLI Line 1 Version: 1    22 April 2014

DONEPEZIL HYDROCHLORIDE 5 mg AND 10 mg FILM-COATED TABLETS

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 haveany 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 arethesameas yours.

♦    If you get any side effects, talk to your doctor or pharmacist.This includesany possible side effects not listed in this leaflet. See section 4.

1. What Donepezil Hydrochloride Film-coated Tablets are and what they are used for

2. What you need to know before you take Donepezil Hydrochloride Film-coated Tablets

3. How to take Donepezil Hydrochloride Film-coated Tablets

4. Possible side effects

5. How to store Donepezil Hydrochloride Film-coated Tablets

6. Contents of the pack and other information

OWHAT DONEPEZIL

HYDROCHLORIDE FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR

Donepezil hydrochloride belongs to a group of medicines called acetylcholinesterase inhibitors. Donepezil hydrochloride increases the levels of a substance (acetylcholine) in the brain involved in memoryfunction byslowing down the break down of acetylcholine.

It 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.Asa result, sufferers of Alzheimer's disease find it more and moredifficult to carry out their normal daily activities. It is for use only in adult patients.

3

WHAT YOU NEED TO KNOW BEFORE YOU TAKE DONEPEZIL HYDROCHLORIDE FILM-COATED TABLETS

♦    anticholinergicsmedicines, e.g. tolterodine

♦    antibiotics e.g. erythromycin, rifampicin

♦    anti-fungal medicines e.g. ketoconazole

♦    anti-depressantse.g.fluoxetine

♦    anticonvulsantse.g.phenytoin, carbamazepine

♦    medication for a heart condition e.g. quinidine, beta-blockers (propanolol and atenolol)

♦    musclerelaxantse.g.diazepam, succinylcholine

♦    general anaesthetic

♦    medicinesobtainedwithouta 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 andthe anaesthetistthatyou are taking donepezil hydrochloride.This is because your medicine may affectthe amount of anaesthetic needed.

Donepezil hydrochloride can be used in patients with kidney disease or mild to moderate liverdisease.Tell your doctor first ifyou have kidney or liver disease. Patients with severe liverdisease should nottake Donepezil hydrochloride.

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

If you arein doubt, consultyour doctor or pharmacist before using Donepezil Hydrochloride Film-coated Tablets. Donepezil Hydrochloride Film-coated Tablets with food and drink and alcohol Donepezil Hydrochloride Film-coated Tablets should be taken with a drink of water. Food will not influence the effect of Donepezil hydrochloride. Donepezil hydrochloride should not be taken with alcohol becausealcohol may change its effect.

Pregnancy and breast-feeding

Donepezil hydrochloride should not be used while breast-feeding.

If you are pregnant, or think you might be pregnant or are planning to have a baby, ask your doctor for advice before taking any medicine.

Driving and using machines

Alzheimer'sdisease may impair your ability to drive or operate machinery. Do not drive or use any tools or machines unless yourdoctor tells you that it is safe to do so.

Do not take Donepezil Hydrochloride Film-coated Tablets if you are

♦    allergic (hypersensitive) to donepezil hydrochloride, or to piperidine derivatives, orany of the other ingredients of Donepezil Hydrochloride Film-coated Tablets listed in section 6.

Tell your doctor if any of these applies to you.

Warnings and precautions

Treatmentwith Donepezil Hydrochloride Film-coatedTabletsshould only be started and supervised by a doctorwith experience in diagnosing and treating Alzheimer's dementia.

Tell your doctor or pharmacist before taking Donepezil hydrochloride if you have or have had:

♦    stomach or duodenal ulcers

♦    seizure (fits) or convulsions

♦    a heart condition (especially if you have an irregular or very slow heart beat)

♦    asthma or other long term lung disease

♦    liverproblemsorhepatitis

♦    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 Film-coated Tablets

Tellyourdoctor or pharmacist ifyou are taking, have recently taken or mighttake any other medicines.

This includes medicines that your doctor has not prescribed for you butwhich you have boughtyourself from a chemist/pharmacist. It also appliesto medicines you maytake sometime inthe future if you continue totake Donepezil hydrochloride.This is because these medicines mayweaken or strengthen the effects of Donepezil hydrochloride. Especially tell yourdoctor if you are taking any of the following types of medicines:

♦    other Alzheimer'sdisease 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

Also, your medicine can cause tiredness, dizziness and muscle cramp. If you experience any of these effectsyou must not drive or operate machinery. Donepezil Hydrochloride Film-coated Tablets contain lactose monohydrate Donepezil Hydrochloride Film-coated Tablets contain lactose monohydrate, a type of sugar. If you have been told by yourdoctorthatyou have intolerance to some sugars, contact yourdoctor before taking this medicinal product.

HOW TO TAKE DONEPEZIL HYDROCHLORIDE FILM-COATED TABLETS

Always take this medicine exactly as your doctor or pharmacist has told you. Check with yourdoctor or pharmacist ifyou are not sure.

Use in children and adolescents

Donepezil hydrochloride tabletsare not recommended for children and adolescents below the age of 18 years. How much Donepezil hydrochloride should you take?

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. Swallowyour Donepezil hydrochloride tablet 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 medicineand on whatyour doctor recommends.The maximum recommended dose is 10 mg each night. Always follow your doctor's, or pharmacist's adviceabout how and when to take your medicine.

Do notalterthe dose yourself without yourdoctor's advice.

For how long should you take Donepezil hydrochloride?

Your doctor or pharmacistwill adviseyou on how long you should continueto take yourtablets.You will need to seeyour doctor from time to time to review your treatment and assess yoursymptoms.

If you take more Donepezil hydrochloride tablets than you should

DO NOT take more than one tablet each day. Call yourdoctor immediately ifyou take more than you should. If you cannot contactyour 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 ordizziness when standing), breathing problems, losing consciousness and seizures (fits) or convulsions.

If you forget to take Donepezil hydrochloride tablets

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 morethan one week, call your doctor before taking any more medicine.

If you stop taking Donepezil hydrochloride

Do not stop taking the tabletsunless told to do so by yourdoctor. If you stop taking Donepezil hydrochloride, 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 hydrochloride.

Tell your doctor if you haveany ofthese effects while you are taking Donepezil hydrochloride.

Serious side effects:

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

♦    liverdamagee.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 1000 people).

♦    stomachorduodenalulcers.The symptoms of ulcersare 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 blacktar like stools orvisible blood from the rectum (may affect up to 1 in 100 people).

♦    seizures (fits) or convulsions (may affect up to 1 in 100 people)

♦    feverwith muscle stiffness, sweating or a lowered level of consciousness (a disorder called "Neuroleptic Malignant Syndrome”) (may affect up to 1 in 10,000 people).

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

♦    diarrhoea

♦    feeling or being sick

♦    headaches.

Common side effects (may affect up to 1 in 10 people)

♦    the common cold

♦    loss of appetite

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

♦    unusualdreamsandnightmares

♦    agitation

♦    aggressive behaviour

♦    fainting

♦    dizziness

♦    difficulty in sleeping (insomnia)

♦    stomachfeelinguncomfortable

♦    rash

♦    itching

♦    musclecramps

♦    passingurineuncontrollably

♦    tiredness

♦    pain

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

Uncommon side effects (may affect up to 1 in 100 people)

♦    slow heart beat.

Rare side effects (may affect up to 1 in 1000 people)

♦    shaking, stiffness or uncontrollable movement especially of the faceand tongue but also ofthe limbs.

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 theYellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety ofthis medicine.

©HOW TO STORE DONEPEZIL HYDROCHLORIDE FILM-COATED TABLETS

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 or blister after 'EXP'.The expiry date refers tothe last day ofthat 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.

©CONTENTS OF THE PACK AND OTHER INFORMATION

What Donepezil Hydrochloride Film-coated Tablets contain

♦ Theactive substanceisdonepezil hydrochloride. Each film-coated tablet contains 5 mg or 10 mg of donepezil hydrochloride.

♦ The other ingredients ofthe tablet core are maize starch, lactose monohydrate, cellulose, microcrystalline, sodium starch glycollate, type A, silica, colloidal anhydrous, magnesium stearate.The film-coating contains:

5 mg film-coated tablets: lactose monohydrate, hypromellose 15 cp, titanium dioxide (E171) and macrogol 4000.

10 mg film-coated tablets: lactose monohydrate, hypromellose 15 cp, titanium dioxide (E171) and macrogol 4000 and yellow iron oxide (E172).

What Donepezil Hydrochloride Film-coated Tablets look like and contents of the pack Donepezil Hydrochloride 5 mg Film-coated Tablets are white to off-white, round, biconvexfilm-coated tablets debossed "DN 5” on one side.

Donepezil Hydrochloride 10 mg Film-coated Tablets areyellow, round, biconvexfilm-coated tablets debossed "DN 10” on one side.

Thefilm-coated tablets are supplied in blister packs of 7, 28, 30, 50, 56, 60, 84, 90, 98 or 120 film-coated tablets. Thefilm-coated tablets are supplied in blister calendar packs of 7, 28, 56, 84 or 98 film-coated tablets.

Notall pack sizes may be marketed. Marketing Authorisation Holder Pliva Pharma Limited Ridings Point, Whistler Drive Castleford, West Yorkshire,

WF10 5HX UNITED KINGDOM Manufacturer

TEVA UK Limited, Brampton Road, Hampden Park, Eastbourne,

East Sussex, BN22 9AG, UK.

This leaflet was last revised in 04/2014.

PL 10622/0405 & 0406.

TFWTI

13020-G

DONEPEZIL HYDROCHLORIDE 5 mg AND 10 mg FILM-COATED TABLETS

PACKAGE LEAFLET: INFORMATION FOR THE USER

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, askyourdoctor 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.

♦    Ifyou get any side effects, talkto your doctor or pharmacist.This includes any possible side effects not listed in this leaflet. See section 4.

1.    What Donepezil Hydrochloride Film-coated Tablets are and what they are used for

2. What you need to know before you take Donepezil Hydrochloride Film-coated Tablets

3. How to take Donepezil Hydrochloride Film-coated Tablets

4. Possible side effects

5. How to store Donepezil Hydrochloride Film-coated Tablets

6. Contents of the pack and other information

" WHAT DONEPEZIL HYDROCHLORIDE FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR

Donepezil hydrochloride belongs to a group of medicines called acetylcholinesterase inhibitors. Donepezil hydrochloride increases the levels of a substance (acetylcholine) inthe brain involved in memory function by slowing down the break down of acetylcholine.

It 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. It is for use only in adult patients.

^ WHAT YOU NEED TO KNOW BEFORE YOU TAKE DONEPEZIL HYDROCHLORIDE FILM-COATED TABLETS

Do not take Donepezil Hydrochloride Film-coated Tablets if you are

♦    allergic (hypersensitive) to donepezil hydrochloride,orto piperidine derivatives, orany of the other ingredients of Donepezil Hydrochloride Film-coated Tablets listed in section 6.

Tell yourdoctor if any ofthese applies to you.

Warnings and precautions Treatmentwith Donepezil Hydrochloride Film-coatedTablets should only be started and supervised by a doctor with experience in diagnosing and treating Alzheimer's dementia.

Tell your doctor or pharmacist before taking Donepezil hydrochloride if you have or have had:

♦    stomach or duodenal ulcers

♦    seizure (fits) or convulsions

♦    a heart condition (especially ifyou have an irregularorvery 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 orthinkyou might be pregnant.

Other medicines and Donepezil Hydrochloride Film-coated Tablets

Tell your doctoror pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that your doctor has not prescribed foryou but which you have bought yourself from a chemist/pharmacist. It also applies to medicines you may take sometime in the future ifyou 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 ofthe following types of medicines:

♦    other Alzheimer's disease medicines, e.g. galantamine

♦    pain killers ortreatmentfor arthritis e.g. aspirin, non-steroidal anti-inflammatory (NSAID) drugs such as ibuprofen, ordiclofenac sodium

♦    anticholinergics medicines, e.g. tolterodine

♦    antibiotics e.g. erythromycin, rifampicin

♦    anti-fungal medicines e.g. ketoconazole

♦    anti-depressants e.g. fluoxetine

♦    anticonvulsants e.g. phenytoin, carbamazepine

♦    medication fora 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 yourdoctorand 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 liverdisease. Tell your doctor first ifyou have kidney or liver disease. Patients with severe liver disease should not take Donepezil hydrochloride.

Tell your doctor or pharmacist the name ofyourcaregiver.Your caregiverwill helpyouto takeyour medicine as it is prescribed.

If you are in doubt, consult your doctor or pharmacist before using Donepezil Hydrochloride Film-coatedTablets.

Donepezil Hydrochloride Film-coated Tablets with food and drink and alcohol

Donepezil Hydrochloride Film-coated Tablets should be taken with a drink of water. Food will not influence the effect of Donepezil hydrochloride. Donepezil hydrochloride should not be taken with alcohol because alcohol may change its effect. Pregnancy and breast-feeding Donepezil hydrochloride should not be usedwhile breast-feeding.

Ifyou are pregnant, orthinkyou might be pregnant or are planning to have a baby, askyour doctorfor advice before taking any medicine. Driving and using machines Alzheimer's disease may impair your ability to drive oroperate machinery. Do not drive or use any tools or machines unless yourdoctor tells you that it is safe to do so.

Also, your medicine can cause tiredness, dizziness and muscle cramp. Ifyou experience any of these effects you must not drive or operate machinery.

Donepezil Hydrochloride Film-coated Tablets contain lactose monohydrate Donepezil Hydrochloride Film-coatedTablets contain lactose monohydrate, a type of sugar. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

A HOW TO TAKE DONEPEZIL HYDROCHLORIDE FILM-COATED TABLETS

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

Use in children and adolescents Donepezil hydrochloride tablets are not recommended for children and adolescents below the age of18 years.

How much Donepezil hydrochloride should you take?

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 hydrochloride tablet with a drink of water before you go to bed at night. The tablet strength you will take may change depending on the length oftime 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 hydrochloride?

Your doctor or pharmacist will advise you on how long you should continue to take yourtablets.You will need to see your doctorfrom time to time to reviewyourtreatment and assess yoursymptoms.

If you take more Donepezil hydrochloride tablets 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 Accidentand 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 tablets Ifyou 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 fora forgotten tablet.

Ifyou forget to take your medicine for more than one week, call your doctor before taking any more medicine.

If you stop taking Donepezil hydrochloride

Do not stop taking the tablets unless told to do so by yourdoctor. Ifyou stop taking Donepezil hydrochloride, the benefits of your treatment will gradually fade away. Ifyou have any further questions on the use of this medicine, askyour doctor or pharmacist.

^ 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 hydrochloride.

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

Serious side effects:

You musttellyourdoctor immediately ifyou noticethese 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 ofthe skin and eyes, and dark coloured urine (may affect upto 1 in 1000 people).

♦    stomach or duodenal ulcers.The symptoms ofulcers are stomach pain and discomfort (indigestion) felt between the navel and the breast bone (may affect upto

1 in 100 people).

♦    bleeding in the stomach or intestines.This may cause you to pass black tar like stools orvisible blood from the rectum (may affect up to 1 in 100 people).

♦    seizures (fits) or convulsions (may affect upto 1 in 100 people)

♦feverwith musclestiffness, sweating ora lowered level of consciousness (a disordercalled "Neuroleptic Malignant Syndrome") (may affect upto 1 in 10,000 people). Very common side effects (may affect more than 1 in 10 people)

♦    diarrhoea

♦    feeling or being sick

♦    headaches.

Common side effects (may affect up to 1 in 10 people)

♦    the common cold

♦    loss ofappetite

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

♦    unusual dreams and nightmares

♦    agitation

♦    aggressive behaviour

♦    fainting

♦    dizziness

♦    difficulty in sleeping (insomnia)

♦    stomach feeling uncomfortable

♦    rash

♦    itching

♦    muscle cramps

♦    passing urine uncontrollably

♦    tiredness

♦    pain

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

Uncommon side effects (may affect up to 1 in 100 people)

♦    slow heart beat.

Rare side effects (may affect up to 1 in 1000 people)

♦    shaking, stiffness or uncontrollable movement especially ofthe face and tongue but also ofthe limbs.

Reporting of side effects

Ifyou get any side effects, talkto yourdoctoror pharmacist.This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via theYellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

13 HOW TO STORE DONEPEZIL ^w HYDROCHLORIDE FILM-COATED TABLETS

Keep this medicine out of the sight and reach of children.

Do not use this medicine afterthe expiry date which is stated on the carton or 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 wastewateror household waste. Askyour pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

" CONTENTS OF THE PACK AND OTHER INFORMATION

What Donepezil Hydrochloride Film-coated Tablets contain

♦    The active substance is donepezil hydrochloride. Each film-coated tablet contains 5 mg or10 mg of donepezil hydrochloride.

♦    The other ingredients ofthe tablet core are maize starch, lactose monohydrate, cellulose, microcrystalline, sodium starch glycollate, type A, silica, colloidal anhydrous, magnesium stearate. The film-coating contains:

5 mg film-coated tablets: lactose monohydrate, hypromellose 15 cp, titanium dioxide (E171) and macrogol 4000.

10 mg film-coated tablets: lactose monohydrate, hypromellose 15 cp, titanium dioxide (E171) and macrogol 4000 and yellow iron oxide (E172).

What Donepezil Hydrochloride Film-coated Tablets look like and contents of the pack

Donepezil Hydrochloride 5 mg Film-coatedTablets are white to off-white, round, biconvex film-coated tablets debossed "DN 5" on one side.

Donepezil Hydrochloride 10 mg Film-coatedTablets are yellow, round, biconvex film-coated tablets debossed "DN 10" on one side.

The film-coated tablets are supplied in blister packs of 7, 28, 30, 50, 56, 60, 84, 90, 98 or 120 film-coated tablets.

The film-coated tablets are supplied in blistercalendar packs of 7, 28, 56, 84 or98 film-coated tablets.

Not all packsizes may be marketed. Marketing Authorisation Holder Pliva Pharma Limited Ridings Point, Whistler Drive Castleford, West Yorkshire,

WF10 5HX UNITED KINGDOM Manufacturer

TEVA UK Limited, Brampton Road, Hampden Park, Eastbourne,

East Sussex, BN22 9AG, UK.

This leaflet was last revised in 04/2014.

PL 10622/0405 & 0406.

13017-G