Aricept 10mg Tablets
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S528 Leaflet Aricept 20130226
PACKAGE LEAFLET: INFORMATION FOR THE USER ARICEPT 10mg TABLETS (donepezil hydrochloride)
Your medicine is called as Aricept 10mg Tablets but will be referred
to as Aricept throughout the following patient information leaflet.
Information regarding other strengths (Aricept 5mg Tablets) is also
present in this leaflet
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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Aricept is and what it is used for
2. Before you take Aricept
3. How to take Aricept
4. Possible side effects
5. How to store Aricept
6. Further information
1. WHAT ARICEPT IS AND WHAT IT IS USED FOR
Aricept (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 break down 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.
Aricept is for use in adult patients only.
2. BEFORE YOU TAKE ARICEPT
Do NOT take Aricept
• if you are allergic (hypersensitive) to donepezil hydrochloride, or to piperidine derivatives, or any of the other ingredients of Aricept listed in section 6
Take special care with Aricept
Tell your doctor or pharmacist before starting to take Aricept if you have or have had:
• stomach or duodenal ulcers
• seizures (fits) or convulsions
• a heart condition (irregular or very slow heartbeat)
• 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 or think you might be pregnant.
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 Aricept. This is because these medicines may weaken or strengthen the effects of Aricept. 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. 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 Aricept. This is because your medicine may affect the amount of anaesthetic needed.
Aricept 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 Aricept.
Tell your doctor or pharmacist the name of your caregiver. Your caregiver will help you to take your medicine as it is prescribed. Taking Aricept with food and drink Food will not influence the effect of Aricept.
Aricept should not be taken with alcohol because alcohol may change its effect.
Pregnancy and breast-feeding
Aricept 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 Aricept
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 Aricept.
3. HOW TO TAKE ARICEPT
How much Aricept 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 Aricept tablet with a drink of water before you go to bed at night.
The blister strip is marked with the days of the week to help you:
Lun = Monday, Mar = Tuesday, Mer = Wednesday, Gio = Thursday, Ven = Friday, Sab = Saturday, Dom = Sunday.
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 Aricept?
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 Aricept
Do not stop taking the tablets unless told to do so by your doctor. If you stop taking Aricept, the benefits of your treatment will gradually fade away.
If you take more Aricept 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 Aricept
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, Aricept can cause side effects, although not everybody gets them.
The following side effects have been reported by people taking Aricept.
Tell your doctor if you have any of these effects while you are taking Aricept.
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").
• 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 side effects (affects more than 1 user in 10):
• diarrhoea
• feeling or being sick
• headaches
Common side effects (affects 1 to 10 users in 100):
• muscle cramp
• tiredness
• difficulty in sleeping (insomnia)
• the 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 (affects 1 to 10 users in 1,000):
• slow heartbeat
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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE ARICEPT
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Do not store above 30°C.
• Do not use after the expiry date printed on the carton label or blister strip.
• If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.
• If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
• 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 Aricept contains
• Each tablet contains 10mg of the active ingredient, donepezil hydrochloride,
• Aricept also contain following inactive ingredients: lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate, talc, macrogol, hypromellose, titanium dioxide (E171) and yellow iron oxide (E172).
What Aricept looks like and contents of the pack
• Aricept are round yellow film-coated tablet plain on both sides.
• Aricept are available as calendar blister packs of 28 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.
Manufacturer
Aricept tablets are manufactured by either:
• Pfizer PGM, Zone Indistrielle 29, Route des Industries, 37530 Poce-sur-Cisse, France or
• Eisai Manufacturing Limited, European Knowledge Centre, Mosquito Way, Hatfield, Herts, AL10 9SN, United Kingdom
| POM | PL No. 19488/0528
Leaflet revision date: 26 February 2013
Aricept is a registered trade mark of Eisai Co Ltd, Japan.
S528 Leaflet Aricept 20130226
S528 Leaflet Donepezil 20130226
PACKAGE LEAFLET: INFORMATION FOR THE USER DONEPEZIL HYDROCHLORIDE 10mg TABLETS (donepezil hydrochloride)
Your medicine is called as Donepezil Hydrochloride 10mg but will be referred to as Donepezil throughout the following patient information leaflet.
Information regarding other strength (Donepezil Hydrochloride 5mg Tablets) is also present in this leaflet.
You and your caregiver should read all of this leaflet carefully before you start taking this medicine.
Read all of this leaflet carefully before you start taking Donepezil Tablets
• 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.
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 Tablets. This is because these medicines may weaken or strengthen the effects of Donepezil 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, 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
• medicines obtained without a prescription e.g. herbal remedies
In this leaflet:
1. What Donepezil Tablets are and what they are used for
2. Before you take Donepezil Tablets
3. How to take Donepezil Tablets
4. Possible side effects
5. How to store Donepezil Tablets
6. Further information
1. WHAT DONEPEZIL TABLETS ARE AND WHAT THEY ARE USED FOR
Donepezil Tablets (donepezil hydrochloride) belong 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 break down 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 Tablets are for use in adult patients only.
2. BEFORE YOU TAKE DONEPEZIL TABLETS
Do NOT take Donepezil Tablets:
• if you are allergic (hypersensitive) to donepezil hydrochloride, or to piperidine derivatives, or any of the other ingredients of Donepezil Tablets listed in section 6
Take special care with Donepezil Tablets:
Tell your doctor or pharmacist before starting to take Donepezil Tablets if you have or have had:
• stomach or duodenal ulcers
• seizures (fits) or convulsions
• a heart condition (irregular or very slow heartbeat)
• 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 or think you might be pregnant.
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 Tablets. This is because your medicine may affect the amount of anaesthetic needed.
Donepezil 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 Tablets.
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 Tablets with food and drink
Food will not influence the effect of Donepezil Tablets.
Donepezil Tablets should not be taken with alcohol because alcohol may change its effect.
Pregnancy and breast-feeding
Donepezil Tablets should not be used while breast-feeding.
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 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 Tablets.
3. HOW TO TAKE DONEPEZIL TABLETS
How much Donepezil Tablets 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 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 10mg 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 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 Tablets
Do not stop taking the tablets unless told to do so by your doctor. If you stop taking Donepezil Tablets, the benefits of your treatment will gradually fade away.
If you take more Donepezil 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 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 Tablets can cause side effects, although not everybody gets them. The following side effects have been reported by people taking Donepezil Tablets.
Tell your doctor if you have any of these effects while you are taking Donepezil Tablets.
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").
• 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 side effects (affects more than 1 user in 10):
• diarrhoea
• feeling or being sick
• headaches
Common side effects (affects 1 to 10 users in 100):
• muscle cramp
• tiredness
• difficulty in sleeping (insomnia)
• the 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 (affects 1 to 10 users in 1,000):
• slow heartbeat
Rare side effects (effects 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 TABLETS
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Do not store above 30°C.
• Do not use after the expiry date printed on the carton label or blister strip.
• If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.
• If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
• 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 Tablets contain
• Each tablet contains 10mg of the active ingredient, donepezil hydrochloride,
• Donepezil Tablets also contain following inactive ingredients: lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate, talc, macrogol, hypromellose, titanium dioxide (E171) and yellow iron oxide (E172).
What Donepezil Tablets look like and contents of the pack
• Donepezil Tablets are round yellow film-coated tablet plain on both sides.
• Donepezil Tablets are available as calendar blister packs of 28 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.
Manufacturer
Donepezil tablets are manufactured by either:
• Pfizer PGM, Zone Indistrielle 29, Route des Industries, 37530 Poce-sur-Cisse, France or
• Eisai Manufacturing Limited, European Knowledge Centre, Mosquito Way, Hatfield, Herts, AL10 9SN, United Kingdom
| POM | PL No. 19488/0528
Leaflet revision date: 26 February 2013
S528 Leaflet Donepezil 20130226