Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using Aricept?
Aricept contains the active ingredient donepezil hydrochloride. Aricept is used to
treat mild, moderate and severe Alzheimer’s disease, also called dementia of the Alzheimer’s
type.
2. What should I know before I use Aricept?
Do not use if you have ever had an allergic reaction to Aricept or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with Aricept and affect how it works.
4. How do I use Aricept?
The usual starting dose is one Aricept 5 mg tablet each day
After one month, your doctor will assess your response and may increase your dose
to one Aricept 10 mg tablet each day.
5. What should I know while using Aricept?
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Things you should do
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Remind any doctor or dentist you visit that you are using Aricept.
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Things you should not do
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Do not stop taking your medicine or change the dosage without checking with your doctor
first.
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Driving or using machines
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Aricept may cause fatigue, dizziness and muscle cramps, especially at the start of
treatment.
Be careful driving or operating machinery until you know how Aricept affects you.
Alzheimer’s disease may affect your ability to drive or operate machinery.
Ask your doctor whether it is safe for you to continue to drive or operate machinery.
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Looking after your medicine
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Keep your tablets in their blister pack until it is time to take them.
Keep your tablets in a cool, dry place where the temperature stays below 30°C .
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6. Are there any side effects?
Common side effects include heartburn, indigestion, stomach pain, headache, dizziness,
difficulty in sleeping, unusual tiredness, feeling sick, diarrhoea, vomiting, loss
of appetite, weight loss, bruising, muscle cramps, joint pain, tingling or numbness
of the hands or feet, depression, unusual dreams, agitation, aggressive behaviour,
difficulty in urinating or passing urine more often.
Active ingredient(s): donepezil hydrochloride (doe-knee-pra-zeal hi-dro-claw-ride)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Aricept. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using Aricept.
Where to find information in this leaflet:
1. Why am I using Aricept?
Aricept contains the active ingredient donepezil hydrochloride. Aricept is an acetylcholinesterase inhibitor. They are thought to work by increasing
the level of a chemical called acetylcholine in the brain.
Aricept is used to treat mild, moderate and severe Alzheimer's disease, also called
dementia of the Alzheimer's type. Aricept will not cure the disease, but should help
your memory and improve your ability to think more clearly.
2. What should I know before I use Aricept?
Warnings
Do not use Aricept if:
1. you are allergic to donepezil hydrochloride, piperidine derivatives, or any of the
ingredients listed at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
2. the expiry date on the pack has passed
3. the packaging is torn or shows signs of tampering.
Check with your doctor if you:
have any allergies to any other medicines, foods, preservatives or dyes
have any other medical conditions, including
heart problems (such as irregular or very slow heartbeat, heart failure, myocardial
infarction)
a heart condition called ‘prolonged QT interval’ or a history of certain abnormal
heart rhythms called Torsade de Pointes or if anyone in your family have ‘prolonged
QT interval’
low levels of magnesium or potassium in your blood
stomach problems, particularly gastric or duodenal ulcer
seizures or fits
asthma or obstructive lung disease
loss of memory or other mental capacity due to stroke or blood vessel problems
tendencies toward aggressive behaviour.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor or pharmacist if you are breastfeeding or intend to breastfeed.
Children
Aricept is not recommended for use in children.
The safety and effectiveness of Aricept in children has not been established.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with Aricept and affect how it works.
Tell your doctor or pharmacist if you are taking any medicines for any other condition,
including
any other medicine for dementia
medicines used to relieve stomach cramps or spasms, Parkinson’s disease or travel
sickness
medicines used to relax muscles
medicines used in general anaesthesia
anti-fungal medicines e.g. ketoconazole
medicines for bacterial infections e.g. clarithromycin, erythromycin, levofloxacin,
moxifloxacin, rifampicin
dexamethasone, a corticosteroid medicine
medicines for heart rhythm problems e.g. amiodarone, sotalol
medicines for depression e.g. citalopram, escitalopram, amitriptyline, fluoxetine
medicines for psychosis e.g. pimozide, sertindole, ziprasidone
medicines used to treat
difficulty in passing urine
arthritis, pain or inflammation known as non-steroidal anti-inflammatory drugs (NSAIDs)
high blood pressure or fast heartbeat
asthma
diarrhoea
epilepsy - carbamazepine, phenobarbitone or phenytoin.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Aricept.
4. How do I use Aricept?
How much to take
the usual starting dose for Aricept is one 5 mg tablet each day.
after 1-month, your doctor will assess your response and may increase your dose to
one Aricept 10 mg tablet each day.
depending on your condition and how you react to the medicine, your doctor may ask
you to take a different dose.
Follow the instructions provided with the medicine.
Do not exceed the recommended dosage.
When to take Aricept
Take your medicine every night just before you go to bed.
Taking it at the same time each day will have the best effect. It will also help
you remember when to take it.
How to take Aricept
Swallow the tablets whole with a full glass of water.
Aricept can be taken with or without food.
Continue taking your medicine for as long as your doctor tells you.
This medicine helps to control your condition, but does not cure it. It is important
to keep taking your medicine even if you feel well.
It may take several weeks for your medicine to take effect, so do not be discouraged
if you do not see an improvement straight away.
If you forget to take it
If you forget to take a tablet, just take one tablet the following day at the usual
time then continue as normal.
Do not take a double dose to make up for the dose you missed.
This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you forget to take your medicine for more than 1-week, call your doctor before
taking any more.
If you have trouble remembering to take your medicine, ask your pharmacist for some
hints.
If you use too much Aricept
If you think that you have used too much Aricept, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using Aricept?
Things you should do
Remind any doctor, dentist or pharmacist you visit that you are using Aricept.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
this medicine.
It may affect other medicines used during surgery.
If you become pregnant while taking this medicine, tell your doctor immediately.
Keep all of your doctor's appointments so that your progress can be checked.
Your doctor may do some tests from time to time to make sure the medicine is working
and to prevent unwanted side effects.
Things you should not do
Do not take this medicine to treat any other complaints unless your doctor says to.
Do not give this medicine to anyone else, even if they have the same condition as
you.
Do not stop taking your medicine or change the dosage without checking with your doctor.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Aricept
affects you.
This medicine may cause fatigue, dizziness and muscle cramps especially at the start
of treatment or if the dose is increased. If you have any of these symptoms, do not
drive, operate machinery or do anything else that could be dangerous.
In addition, Alzheimer's disease may affect your ability to drive or operate machinery.
Ask your doctor whether it is safe for you to continue to drive or operate machinery.
Looking after your medicine
Keep your tablets in their blister pack until it is time to take them.
If you take the tablets out of the pack they may not keep well.
Keep your tablets in a cool, dry place where the temperature stays below 30°C.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If your doctor tells you to stop taking this medicine, if you no longer need to use
this medicine or it is out of date, take it to any pharmacy for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions.
Very serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Aricept contains
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Active ingredient
(main ingredient)
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donepezil hydrochloride
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Other ingredients
(inactive ingredients)
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lactose monohydrate
maize starch
microcrystalline cellulose
hyprolose
magnesium stearate
talc purified
macrogol 8000
hypromellose
titanium dioxide
yellow iron oxide (10 mg tablet only)
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Do not take this medicine if you are allergic to any of these ingredients.
What Aricept looks like
Aricept 5 mg film-coated tablets - white, round tablets with '5' on one side and 'Aricept'
on the other – AUST R 60176.
Aricept 10 mg film-coated tablets - yellow, round tablets with '10' on one side and
'Aricept' on the other – AUST R 60178.
A box contains 28 tablets.
Who distributes Aricept
Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
www.pfizermedinfo.com.au
This leaflet was prepared in January 2022.
© Pfizer Australia Pty Ltd.
® Registered trademark