Donepezil Hydrochloride 10mg Film-Coated Tablets

Informations for option: Donepezil Hydrochloride 10mg Film-Coated Tablets, show other option

Document: leaflet MAH GENERIC_PL 34771-0049 change

Donepezil hydrochloride Tablets should not be taken with alcohol because

alcohol may change its effect.

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Donepezil hydrochloride 10mg 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 Tablets are and what they are used for

2. Before you take Donepezil hydrochloride Tablets

3. How to take Donepezil hydrochloride Tablets

4. Possible side effects

5. How to store Donepezil hydrochloride Tablets

6. Further information

1. WHAT DONEPEZIL HYDROCHLORIDE TABLETS ARE AND WHAT THEY ARE USED FOR

Donepezil hydrochloride Tablets 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 hydrochloride Tablets is for use in adult patients only.

2. BEFORE YOU TAKE DONEPEZIL HYDROCHLORIDE TABLETS

Do NOT take Donepezil hydrochloride Tablets

• if you are allergic (hypersensitive) to donepezil hydrochloride, or to piperidine derivatives, or any of the other ingredients of Donepezil hydrochloride Tablets listed in section 6

Take special care with Donepezil hydrochloride Tablets

Tell your doctor or pharmacist before starting to take Donepezil hydrochloride Tablets if you have or have had:

• 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

• you have extrapyramidal symptoms (shaking, stiffness or uncontrollable movement especially of the face and tongue but also of the limbs). Donepezil hydrochloride Tablets may induce or exacerbate extrapyramidal symptoms.

• Donepezil hydrochloride Tablets 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 Tablets.

Also tell your doctor if you are pregnant or think you might be pregnant. Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicine. 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 Tablets. This is because these medicines may weaken or strengthen the effects of Donepezil hydrochloride Tablets.

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, nonsteroidal antiinflammatory (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 Tablets. This is because your medicine may affect the amount of anaesthetic needed.

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

Taking Donepezil hydrochloride Tablets with food and drink

Food will not influence the effect of Donepezil hydrochloride Tablets.

Pregnancy and breast-feeding

Donepezil hydrochloride tablets 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

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.

Important information about some of the ingredients of Donepezil hydrochloride Tablets

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 hydrochloride Tablets.

3. HOW TO TAKE DONEPEZIL HYDROCHLORIDE TABLETS How much Donepezil hydrochloride Tablets should you take?

Dosage

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 Tablets 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 hydrochloride Tablets?

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 stop taking Donepezil hydrochloride Tablets

Do not stop taking the tablets unless told to do so by your doctor. If you stop taking Donepezil hydrochloride tablets, the benefits of your treatment will gradually fade away. 4_

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Donepezil hydrochloride Tablets can cause side effects, although not everybody gets them.

The following side effects have been reported by people taking Donepezil hydrochloride Tablets.

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

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").

• 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).

Very common side effects (affects more than 1 user in 10):

• diarrhoea

• feeling or being sick

• headaches

Common side effects (affects 1 to 10 users in100):

• muscle cramp

• tiredness

• difficulty in sleeping (insomnia)

• the common cold

• loss of appetite

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

• agitation

• aggressive behavior

• fainting

• dizziness

• stomach feeling uncomfortable

• rash

• itching

• passing urine uncontrollably

• pain

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

• unusual dreams including nightmares

Uncommon side effects (affects 1 to 10 users in 1,000):

• slow heart beat

Rare side effects (affects 1 to 10 users in 10,000):

• stiffness, shaking or uncontrollable movement especially of the face and tongue but also of the limbs

If any of the side effects get 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 TABLETS

Do not store this medicine above 30°C. Keep out of the reach and sight of children.

DO NOT use Donepezil hydrochloride Tablets after the expiry date that is printed on the label. The expiry date refers to the last day of that month.

If your doctor tells you to stop taking your medicine, you should return any you have not used to your pharmacist.

6. FURTHER INFORMATION

What do Donepezil hydrochloride Tablets contains ?

The active substance is donepezil hydrochloride. The 10 mg tablet contains 10 mg of donepezil hydrochloride .

The other ingredients are

Core: Lactose monohydrate, Colloidal silicon dioxide, Microcrystalline cellulose, Pregelatinised starch and Magnesium stearate.

Coating: Hypromellose (E464), Talc(E553b), Propylene glycol(E1520) and Titanium dioxide (E171), Yellow iron oxide (E172).

What do Donepezil hydrochloride tablets look like?

Donepezil hydrochloride Tablets 10 mg are Yellow colour, round shaped, biconvex, film coated tablets, debossed with “ML 88” on one side and plain on other side.

What is in a pack of Donepezil hydrochloride tablets?

The tablets are supplied in packs of 28 tablets.

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Marketing Authorisation Holder

Macleods Pharma UK Ltd

Wynyard Park House, Wynyard Avenue, Wynyard,

Billingham, TS22 5TB, United Kingdom

Manufacturer

Mawdsleys Brooks and Co Ltd

Unit 22, Quest Park, Wheatley Hall Road,

Doncaster, DN2 4LT, United Kingdom

PL 34771/0049

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

United Kingdom Donepezil hydrochloride 10mg Film-coated tablet Germany Donepezilhydrochlorid Macleods 10mg Filmtabletten

Italy Memac 10mg compresse rivistite con film

Spain Donepezil Macleods 10mg comprimidos recubiertos con

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This leaflet was last revised in {12/2015}.

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