Document: Donepezil Jubilant film-coated tablet ENG PL change

• Donepezil Jubilant film-coated tablet PL
• Donepezil Jubilant film-coated tablet ENG PL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Donepezil Jubilant 5 mg film-coated tablets

Donepezil Jubilant 10 mg film-coated tablets

donepezil hydrochloride

You and your caregiver should 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 possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

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

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

3. How to take Donepezil Jubilant

4. Possible side effects

5. How to store Donepezil Jubilant

6. Contents of the pack and other information

Donepezil Jubilant (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.

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 Jubilant is for use in adult patients only.

Do not take Donepezil Jubilant

Warnings and precautions

Talk to your doctor or pharmacist before taking Donepezil Jubilant if you have or have had any of the following conditions:

• 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

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

Other medicines and Donepezil Jubilant

Please 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 Jubilant. This is because these medicines may weaken or strengthen the effects of Donepezil Jubilant.

Especially tell your doctor or pharmacist 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

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

Donepezil Jubilant 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 Jubilant.

Donepezil Jubilant with food and drink

Food will not influence the effect of Donepezil Jubilant.

Donepezil Jubilant should not be taken with alcohol because alcohol may change its effect.

Pregnancy and 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.

Donepezil Jubilant should not be used while breast-feeding.

Driving and using machines

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

Alzheimer’s disease may also 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.

Donepezil Jubilant contains lactose.

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

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Do not alter the dose yourself without your doctor’s advice.

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

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

Swallow your Donepezil Jubilant 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 medicine and on what your doctor recommends. The maximum recommended dose is 10 mg each night.

For how long should you take Donepezil Jubilant?

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 Jubilant 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 Jubilant

If you have forgotten 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.

If you stop taking Donepezil Jubilant

Do not stop taking the tablets unless told to do so by your doctor. If you stop taking Donepezil Jubilant, 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, this medicine can cause side effects, although not everybody gets them.

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

Serious side effects:

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

Other possible side effects:

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

• diarrhoea

• feeling or being sick

• headaches

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

• muscle cramp

• tiredness

• difficulty in sleeping (insomnia)

• common cold

• loss of appetite

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

• unusual dreams including nightmares

• agitation

• aggressive behaviour

• fainting

• dizziness

• stomach feeling uncomfortable

• rash

• itching

• passing urine uncontrollably

• pain

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

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