Donepezil Hydrochloride 5 Mg Orodispersible Tablets
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1. WHAT DONEPEZIL IS AND WHAT IT IS USED FOR
2. BEFORE YOU TAKE DONEPEZIL
3. HOW TO TAKE DONEPEZIL
3. Tip the tablet out onto your hand.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Donepezil hydrochloride 5 mg
orodispersible tablets
Donepezil hydrochloride 10 mg
orodispersible tablets Donepezil hydrochloride
You and your caregiver should 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 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 is and what it is used for
2. Before you take Donepezil
3. How to take Donepezil
4. Possible side effects
5. How to store Donepezil
6. Further information
Donepezil belongs to a group of medicines called acetylcholinesterase inhibitors.
Donepezil is used to treat the symptoms of dementia in people diagnosed as having mild to moderately severe Alzheimer's disease.
Do not take Donepezil:
• if you are allergic (hypersensitive) to donepezil hydrochloride or to piperidine derivatives, or any of the other ingredients of Donepezil.
Take special care with Donepezil
Tell your doctor or pharmacist before starting to take Donepezil if you have or have had:
• stomach or duodenal ulcers
• seizures (fits) or convulsions
• a heart problem (especially irregular or very slow heart beat)
• asthma or other long term lung disease
• liver problems or hepatitis
• difficulty passing urine or mild kidney disease.
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. This is because your medicine may affect the amount of anaesthetic needed.
Donepezil 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.
Taking other medicines
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, 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. itraconazole or 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. succinylcholine,
• general anaesthetic,
• medicines obtained without a prescription e.g. herbal remedies.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking Donepezil with food and drink
Food will not influence the effect of Donepezil.
Do not drink alcohol during treatment with Donepezil because alcohol may reduce its effectiveness.
Pregnancy and breast-feeding
Do not take Donepezil if you are pregnant.
Do not breast-feed while taking Donepezil.
Ask your doctor or pharmacist 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
• Aspartame (E951):
Contains a source of phenylalanine. May be harmful for people with phenylketonuria.
• Glucose (dextrose), sucrose and sorbitol (E420):
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 Donepezil 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.
Usually, you will start by taking 5 mg every night before you go to bed. After one month, your doctor may tell you to take 10 mg every night before you go to bed.
Donepezil orodispersible tablets are fragile. They should not be pushed through the foil in the blister pack as this will cause damage to the tablet. Do not handle the tablets with wet hands as the tablets may break up. Remove a tablet from the package as follows:
1. Hold the blister at the edges and separate one blister cell from the rest of the blister by gently tearing along the perforations around it.
2. Pull up the edge of the foil and peel the foil off completely.
4. Put the tablet on the tongue as soon as it is removed from the packaging.
In a few seconds it begins disintegrating in the mouth and subsequently can be swallowed with or without water. The mouth should be empty before placing the tablet on the tongue.
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.
4. POSSIBLE SIDE EFFECTS
Side effects are classified into the following groups in order of frequency:
|
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 available data |
5. HOW TO STORE DONEPEZIL
6. FURTHER INFORMATION
Donepezil is not recommended for use in children and adolescents (younger than 18 years).
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”).
Do not stop taking the tablets unless told to do so by your doctor.
You will need to see your doctor from time to time to review your treatment and assess your symptoms.
If you take more Donepezil 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
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. Inform your doctor if you have forgotten to take Donepezil for several days. He or she will tell you how to start taking it again.
If you stop taking Donepezil
Do not stop taking the tablets unless told to do so by your doctor. If you
stop taking Donepezil, the benefits of your treatment will gradually fade away.
Like all medicines, Donepezil 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 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)
Very common:
• diarrhoea
• nausea (feeling sick)
• headaches
Common:
• common cold
• loss of appetite
• hallucinations (seeing or hearing things that are not really there)
• agitation
• aggressive behaviour
• fainting
• dizziness
• difficulty in sleeping (insomnia)
• vomiting (being sick)
• stomach feeling uncomfortable
• skin rash
• itching
• muscle cramp
• passing urine uncontrollably
• tiredness
• pain
• accidents (patients may be more prone to falls and accidental injury)
Uncommon:
• slow heart beat
• slight increase in serum concentration of a certain muscle enzyme (creatine kinase)
Rare:
• stiffness, shaking or uncontrollable movement especially of the face and tongue but also of the limbs (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.
Keep out of the reach and sight of children.
Do not use Donepezil after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of that month.
Store in the original blister in order to protect from moisture. This medicinal product does not require any special temperature storage conditions.
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.
What Donepezil contains
• The active substance is donepezil hydrochloride.
Donepezil 5 mg: Each orodispersible tablet contains donepezil hydrochloride monohydrate equivalent to 5 mg donepezil hydrochloride.
Donepezil 10 mg: Each orodispersible tablet contains donepezil hydrochloride monohydrate equivalent to 10 mg donepezil hydrochloride.
• The other ingredients are mannitol (E421), low-substituted hydroxypropylcellulose, calcium silicate, microcrystalline cellulose, magnesium stearate, aspartame (E951) and banana flavouring.
• The banana flavouring consists of maltodextrine, glucose (dextrose), sucrose, gum arabic, sorbitol (E420) and flavouring.
What Donepezil looks like and contents of the pack
Tablets are white round orodispersible tablets, bevel-edged.
Tablets are available in boxes of 10, 28, 30, 50, 56, 60, 84, 90, 98 and 100
orodispersible tablets in blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder & Manufacturer
KRKA, d.d, Novo mesto, Smarjeska cesta 6, 8501 Novo mesto, Slovenia.
Distributed by
Consilient Health (UK) Ltd., 500 Chiswick High Road, London. W4 5RG.
This leaflet was last revised in December 2010
P0094