Donepezil Hydrochloride 10mg Orodispersible Tablets
Out of date information, search anotherS1125 LEAFLET Aricept 20121012
PACKAGE LEAFLET: INFORMATION FOR USER ARICEPT EVESS 10mg ORODISPERSIBLE TABLETS (donepezil hydrochloride)
Your medicine is known as Aricept Evess 10mg Orodispersible Tablets but will be referred to as Aricept Evess throughout the following leaflet.
Information for other strength of Aricept Evess (5mg) is also available 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 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 Aricept Evess is and what it is used for
2. Before you take Aricept Evess
3. How to take Aricept Evess
4. Possible side effects
5. How to store Aricept Evess
6. Further information
1. WHAT ARICEPT EVESS IS AND WHAT IT IS USED FOR
Aricept Evess (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.
Aricept Evess is for use in adult patients only.
2. BEFORE YOU TAKE ARICEPT EVESS
Do NOT take Aricept Evess
• if you are allergic (hypersensitive) to donepezil hydrochloride, or to piperidine derivatives, or any of the other ingredients of Aricept Evess listed in section 6.
Take special care with Aricept Evess
Tell your doctor or pharmacist before starting to take Aricept Evess 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
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 Aricept Evess. This is because these medicines may weaken or strengthen the effects of Aricept Evess.
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 Evess. This is because your medicine may affect the amount of anaesthetic needed.
Aricept Evess 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 Evess.
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 Evess with food and drink
Food will not influence the effect of Aricept Evess.
Aricept Evess should not be taken with alcohol because alcohol may change its effect.
Pregnancy and breast-feeding
Aricept Evess 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.
3. HOW TO TAKE ARICEPT EVESS
How much Aricept Evess should you take?
Usually, you will start by taking 5 mg (one white tablet) every night before you go to bed. After one month, your doctor may tell you to take 10 mg (one yellow tablet) every night before you go to bed.
The tablet should be placed on your tongue and allowed to disintegrate before swallowing, with or without water, according to your preference.
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 Evess?
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.
Do not stop taking the tablets unless told to do so by your doctor. If you stop taking Aricept Evess, the benefits of your treatment will gradually fade away.
If you take more Aricept Evess 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 (lightheadedness or dizziness when standing), breathing problems, losing consciousness and seizures (fits) or convulsions.
If you forget to take Aricept Evess
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 Evess can cause side effects, although not everybody gets them.
The following side effects have been reported by people taking Aricept Evess.
Tell your doctor if you have any of these effects while you are taking Aricept Evess.
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 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 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 EVESS
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Do not use after the expiry date printed on the carton or bottle label.
• 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.
6. FURTHER INFORMATION
What Aricept Evess contains
• Each orodispersible tablet contains 10mg of the active ingredient, donepezil hydrochloride
• Aricept Evess also contains the following inactive ingredients: mannitol, colloidal anhydrous silica, carrageenan, polyvinyl alcohol and yellow ferric oxide.
What Aricept Evess looks like and contents of the pack
• Aricept Evess is yellow, round tablet marked ‘10' on one side and ‘Aricept' on the other side.
• Aricept Evess is available as calendar blister packs of 28 or 98 tablets.
Product Licence holder
Procured from within the EU and repackaged by the PL holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Pfizer PGM, 29, Route des Industries, 37530 Poce-sur-Cisse, France.
|POM | PL No: 19488/1125
Leaflet revision date: 12 October 2012
Aricept Evess is a registered trade mark of Eisai R&D Management Co., Ltd, Japan.
S1125 LEAFLET Aricept 20121012
S1125 LEAFLET Donepezil HCl 20121012
PACKAGE LEAFLET: INFORMATION FOR USER DONEPEZIL HYDROCHLORIDE 10mg ORODISPERSIBLE TABLETS
Your medicine is known as Donepezil Hydrochloride 10mg Orodispersible Tablets but will be referred to as Donepezil Hydrochloride Tablets throughout the following leaflet.
Information for other strength of Donepezil Hydrochloride Tablets (5mg) is also available 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 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 (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 Hydrochloride Tablets are 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
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, 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 Donepezil Hydrochloride Tablets. This is because your medicine may affect the amount of anaesthetic needed.
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.
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.
Donepezil Hydrochloride Tablets should not be taken with alcohol because alcohol may change its effect.
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.
3. HOW TO TAKE DONEPEZIL HYDROCHLORIDE TABLETS
How much Donepezil Hydrochloride Tablets should you take?
Usually, you will start by taking 5 mg (one white tablet) every night before you go to bed. After one month, your doctor may tell you to take 10 mg (one yellow tablet) every night before you go to bed.
The tablet should be placed on your tongue and allowed to disintegrate before swallowing, with or without water, according to your preference.
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.
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.
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 (lightheadedness 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.
• 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 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 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 TABLETS
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Do not use after the expiry date printed on the carton or bottle label.
• 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.
6. FURTHER INFORMATION
What Donepezil Hydrochloride Tablets contain
• Each orodispersible tablet contains 10mg of the active ingredient, donepezil hydrochloride
• Donepezil Hydrochloride Tablets also contain the following inactive ingredients: mannitol, colloidal anhydrous silica, carrageenan, polyvinyl alcohol and yellow ferric oxide.
What Donepezil Hydrochloride Tablets look like and contents
of the pack
• Donepezil Hydrochloride Tablets are yellow, round tablets marked ‘10' on one side and ‘Accept' on the other side.
• Donepezil Hydrochloride Tablets are available as calendar blister packs of 28 or 98 tablets.
Product Licence holder
Procured from within the EU and repackaged by the PL holder:
S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley,
HA0 1DX.
Manufacturer
This product is manufactured by Pfizer PGM, 29, Route des
Industries, 37530 Poce-sur-Cisse, France.
iPOMi PL No: 19488/1125
Leaflet revision date: 12 October 2012
S1125 LEAFLET Donepezil HCl 20121012