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 this medicine.

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

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

-    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

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

2.    Before you take Donepezil hydrochloride

3.    How to take Donepezil hydrochloride

4.    Possible side effects

5.    How to store Donepezil hydrochloride

6.    Further information

1. WHAT DONEPEZIL HYDROCHLORIDE IS

AND WHAT IT IS USED FOR_

Donepezil hydrochloride 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.

2. BEFORE YOU TAKE DONEPEZIL

HYDROCHLORIDE_

Do not take Donepezil hydrochloride

-    if you are allergic (hypersensitive) to donepezil hydrochloride, piperidine derivatives, or any of the other ingredients of Donepezil hydrochloride.

Take special care with Donepezil hydrochloride

Check if one of the warnings listed below applies to you

or applied to you in the past.

Please tell your doctor:

-    if you are going to have an operation that requires you to have a general anaesthetic. Donepezil may exaggerate muscle relaxation during anaesthesia.

-    if you have or ever had a heart problem (specifically the sick sinus syndrome or a comparable condition). Donepezil may slow down your heart rate.

-    if you have or ever had stomach or duodenal ulcers or

if you use a certain type of painkiller (Non-Steroidal Anti-Inflammatory Drugs -NSAIDs, e.g. diclofenac). Concurrent use may lead to an increased risk of stomach or duodenal ulcers. Your doctor will monitor your symptoms (such as pain of the stomach or the intestinum). if you have difficulty passing urine or mild kidney disease. Your doctor will monitor your symptoms.

-    if you have or ever had a seizure. (fits) or convulsions. Donepezil may cause a new seizure. Your doctor will monitor your symptoms.

if you have or ever had extrapyramidal symptoms (uncontrolled movements of the body or face).

Donepezil may induce or exacerbate extrapyramidal symptoms. if you have asthma or other long term lung disease. Your symptoms could get worse.

-    if you have or ever had any liver problems or hepatitis (as your dose may need to be adjusted).

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.

Children and adolescents

Donepezil hydrochloride is not recommended for children and adolescents below the age of 18 years.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Other medicines may be affected by donepezil. They, in turn, may affect how well donepezil works. Donepezil can interact with:

-    medicines used to control    heart rhythm

(quinidine), antifungal medicines (ketoconazole and itraconazole), specific types of antibiotics (erythromycin) and medicines used for the treatment of depression (selective serotonin-reuptake inhibitors, SSRIs, such as fluoxetine). These medicines can intensify the effect of donepezil

-    medicines used for the treatment of tuberculose (rifampicin), medicines used to treat epilepsy (phenytoin and carbamazepine). These medicines can reduce the effect of Donepezil.

. medicines used as short-term muscle relaxation in anesthesia and intensive care (succinylcholine) and certain blood pressure lowering medicines (beta blockers). The effect of both medicines is increased.

-    general anaesthetic

-    other medicines that act the same way as donepezil (such as galantamine or rivastigmine), and some medicines for diarrhoea, Parkinson's disease or asthma, (agonists or antagonists of the cholinergic system).

-    Pain killers or treatment for arthritis such as acetylsalicylic acid, non-steroidal anti-inflammatory (NSAID) medicines such as ibuprofen, or diclofenac

Taking Donepezil hydrochloride with food and drink Do not drink any alcohol during treatment with donepezil because alcohol may reduce its effectiveness.

Pregnancy and breast-feeding

Donepezil hydrochloride should not be used while breastfeeding.

If you are pregnant, or think you might be pregnant, ask your doctor for advice before taking any medicine. Driving and using machines Donepezil has a minor or moderate influence on the ability to drive and use machines.

Alzheimer's disease may impair your ability to drive or use machinery and you must not carry out these activities, unless your doctor tells you that it is safe to do so.

Also, Donepezil hydrochloride can cause fatigue, dizziness and muscle cramp, mainly at the start of treatment or after a dose increase.

If you are affected, do not drive or operate machinery.

Important information about some of the ingredients

of Donepezil hydrochloride

This medicine contains lactose. If you have been told

by your doctor that you have an intolerance to some

sugars, contact your doctor before taking Donepezil

hydrochloride.

3. HOW TO TAKE DONEPEZIL HYDROCHLORIDE

Always take Donepezil hydrochloride exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

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

The usual dose is

Usually, you will start by taking 5 mg donepezil hydrochloride every night. After one month, your doctor may tell you to take 10 mg donepezil hydrochloride every night.

The maximum recommended dose is 10 mg donepezil hydrochloride each night.

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

No dosage adjustment is required if you have kidney problems.

If you have liver problems, your dose may need to be adjusted to your needs by your doctor (see section 2 „Before you take Donepezil hydrochloride¹¹). If you have severe liver disease, your doctor may decide to stop treatment with Donepezil hydrochloride.

Oral use.

Take Donepezil hydrochloride with a drink of water at night before you go to bed.

This medicine is not recommended for use in children and adolescents (younger than 18 years).

Your doctor will tell you 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. Do not stop taking the tablets unless your doctor advises you to.

If you take more Donepezil hydrochloride than you should

Do not take more tablets than you should. If you take more Donepezil hydrochloride than you should, you may experience symptoms such as severe nausea, vomiting, secretion of saliva (salivation), sweating, slow heartbeat (bradycardia), low blood pressure (hypotension), breathing difficulties (respiratory depression), collapse, involuntary contraction of muscles (convulsion) and increased muscle weakness. Call your doctor immediately. If you cannot contact your doctor, contact the local hospital Accident and Emergency department at once. Take the tablets and the carton with you to the hospital, so that the doctor knows what has been taken.

If you forget to take Donepezil hydrochloride If you forget to take a dose, just take your recommended dose 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 hydrochloride

Do not stop treatment without talking to your doctor first, even if you feel better.

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 product, ask your doctor or pharmacist.

| 4. POSSIBLE SIDE EFFECTS    ]

Like all medicines, Donepezil hydrochloride can cause side effects, although not everybody gets them. In most cases, these disappear without having to stop treatment. Serious side effects:

You must tell your doctor immediately if you notice these serious side effects mentioned.

You may need urgent medical treatment.

♦ Fever with muscle stiffness, sweating or a lowered

level of consciousness (a disorder called "Neuroleptic

Malignant Syndrome").

very common: affects more than 1 user in 10

common: affects 1 to 10 users in 100

uncommon: affects 1 to 10 users in 1,000

rare: affects 1 to 10 users in 10,000

very rare: affects less than 1 user in 10,000

not known: frequency cannot be estimated from the

available data

Very common:

diarrhoea, nausea (feeling sick) and headaches.

Common:

common cold, vomiting (being sick) and abdominal disturbances, muscle cramps, fatigue, fainting, dizziness, insomnia (difficulty sleeping), pain, loss of appetite, itching, skin rash, hallucinations, agitation, aggressive behaviour, urinary incontinence, being prone to accidents.

Cases of hallucinations, agitation and aggressive behaviour have been resolved on dose-reduction or withdrawl of Donepezil.

Uncommon:

seizures, slow heart beat, stomach and duodenal ulcers and abdominal disturbances including bleeding in the digestive system (this may cause you to pass

black tar like stools or visible blood from the rectum), minor increase in serum concentration of a certain muscle enzyme (creatine kinase).

Rare:

liver disorders (including hepatitis), uncontrolled movements of the body or face (extrapyramidal symptoms), disorders of the electrical conduction system of the heart (sino-atrial block, atrioventricular block).

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE DONEPEZIL HYDROCHLORIDE Keep out of the reach and sight of children.

Do not use Donepezil hydrochloride after the expiry date which is stated on the carton, the blister or on the bottle. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

HDPE bottle:

The shelf life after first opening the bottle is 90 days. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

| 6. FURTHER INFORMATION    |

What Donepezil hydrochloride contains The active substance is donepezil hydrochloride. Donepezil hydrochloride 5 mg

Each film-coated tablet contains 5 mg donepezil hydrochloride, equivalent to 4.56 mg of donepezil.

Donepezil hydrochloride 10 mg

Each film-coated tablet contains 10 mg donepezil hydrochloride, equivalent to 9.12 mg of donepezil.

The other ingredients are maize starch, lactose monohydrate, microcrystalline cellulose, magnesium stearate, in the tablet core, and hypromellose, macrogol 6000, talc and titanium dioxide (E171) in the film coating.

Additional in Donepezil hydrochloride 10 mg: Ferric oxide yellow (E172) and ferric oxide red (E172)

What Donepezil hydrochloride looks like and

contents of the pack

Donepezil hydrochloride 5 mg

White to off-white coloured, round, biconvex film

coated tablets debossed with ‘5’ on one side and break

line on other side.

Donepezil hydrochloride 10 mg

Peach coloured, round, biconvex film coated tablets debossed with ‘10’ on one side and break line on other side.

The tablets are supplied in

white bottles (HDPE) with child resistant closure, containing 28, 30, 56 or 98 (2 x 49) film-coated tablets or in

PVC/Alu Blister, containing 28, 30, 56, or 98 film-coated tablets or in

OPA/Alu/PVC/Alu Blister with 28, 30, 56, or 98 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Torrent Pharma (UK) Ltd.

Unit 4, Charlwood Court, County Oak Way Crawley, West Sussex. RH11 7XA United Kingdom

Manufacturer

Torrent Pharma (UK) Ltd.

Unit 4, Charlwood Court, County Oak Way Crawley, West Sussex. RH11 7XA,

United Kingdom

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

Germany    Donepezilhydrochlorid Heumann

5 mg/10 mg Filmtabletten Italy    Donepezil Torrent 5 mg/10 mg

Lithuania    Donepezil Torrent 5 mg/10 mg

Romania    Donepezil Torrent 5 mg/10 mg

comprimate filmate

United Kingdom Donepezil hydrochloride 5/10 mg film-coated tablets

This leaflet was last approved in 02/2013

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