ARAZIL®
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.
ARAZIL contains the active ingredient donepezil hydrochloride. ARAZIL is used to treat
mild, moderate and severe Alzheimer’s disease, also called dementia of the Alzheimer’s
type.
For more information, see Section 1. Why am I using ARAZIL? in the full CMI.
Do not use if you have ever had an allergic reaction to donepezil hydrochloride 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.
For more information, see Section 2. What should I know before I use ARAZIL? in the full CMI.
Some medicines may interfere with ARAZIL and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
The usual starting dose for ARAZIL is one 5 mg tablet each day.
After one month, your doctor will assess your response and may increase your dose
to one ARAZIL 10 mg tablet a day.
More instructions can be found in Section 4. How do I use ARAZIL? in the full CMI.
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using ARAZIL.
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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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ARAZIL may cause fatigue, dizziness and muscle cramps, especially at the start of
treatment.
Be careful driving or operating machinery until you know how ARAZIL 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 25°C.
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For more information, see Section 5. What should I know while using ARAZIL? in the full CMI.
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.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
ARAZIL®
Active ingredient:
donepezil hydrochloride
Consumer Medicine Information (CMI)
This leaflet provides important information about using ARAZIL. 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 ARAZIL.
Where to find information in this leaflet:
ARAZIL contains the active ingredient donepezil hydrochloride. ARAZIL is an acetylcholinesterase inhibitor. They are thought to work by increasing
the level of a chemical called acetylcholine in the brain.
ARAZIL is used to treat mild, moderate and severe Alzheimer's disease, also called
dementia of the Alzheimer's type. ARAZIL will not cure the disease, but should help
your memory and improve your thinking capacity.
Do not use ARAZIL if:
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.
the expiry date on the pack has passed.
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.
plan to go to hospital for surgery that requires a general anaesthetic.
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 (epilepsy)
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
ARAZIL is not recommended for use in children.
The safety and effectiveness of ARAZIL in children has not
been established.
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 ARAZIL 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 irregular heartbeat e.g. quinidine
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, phenobarbital 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 ARAZIL.
How much to take
The usual starting dose for ARAZIL is one 5 mg tablet each day.
After one month, your doctor will assess your response and may increase your dose
to one ARAZIL 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 ARAZIL
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 ARAZIL
Swallow the tablets whole with a full glass of water.
Do not divide the tablet into halves.
ARAZIL 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 use ARAZIL
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 one 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 ARAZIL
If you think that you have used too much ARAZIL, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, or
(Australia telephone 13 11 26) for advice, 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.
Things you should do
Remind any doctor, dentist or pharmacist you visit that you are using ARAZIL.
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 ARAZIL
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 25°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 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.
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 about side effects.
Common side effects
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Common side effects
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What to do
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heartburn, indigestion, or stomach pain
headache or 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
changes in sexual drive, particularly increase
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Speak to your doctor or pharmacist if you have any of these side effects and they
worry you.
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Serious side effects
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Serious side effects
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What to do
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seeing, feeling or hearing things that are not there
trembling and shaking of the hands and fingers, shuffling walk and stiffness of the
arms and legs
bending of the back forward and to one side (Pisa syndrome)
severe upper stomach pain, often with nausea, vomiting and fever
changes in the heart activity which can be seen on an electro-cardiogram (ECG) called
‘prolonged QT interval’
fast irregular heartbeat, fainting which could be the symptoms of a life-threatening
condition known as Torsade de Pointes
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Tell your doctor as soon as possible if you notice any of these serious side effects
which may require medical attention.
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Very serious side effects
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Very serious side effects
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What to do
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any breathing difficulties
sudden signs of allergy such as rash, itching or hives, swelling of the face, lips,
tongue or other parts of the body, shortness of breath, wheezing or difficulty breathing
fainting, especially if you have a slow or irregular heartbeat
vomiting blood or material that looks like coffee grounds
black sticky bowel motions (stools)
convulsions or fits
weakness, shortness of breath, yellowing of the skin, dark brown urine and stomach
pain
sudden increase in body temperature, sweating, muscle stiffness, or altered consciousness
(awareness of oneself and ones surrounding)
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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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.
This medicine is only available with a doctor's prescription.
What ARAZIL 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
hyprolose
microcrystalline cellulose
magnesium stearate
Opadry Complete film coating system White Y-1-7000 (ID 1475) or Instacoat Universal
White A05G15138 (ID 144681) containing Hypromellose, Macrogol/PEG MW 400, and Titanium
dioxide
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Potential allergens
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sugars as lactose and trace quantities of sulfites
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Do not take this medicine if you are allergic to any of these ingredients.
What ARAZIL looks like
ARAZIL 5 mg tablet is 7 mm white, film coated, round tablets embossed with "DL" over
"5" on one side and "G" on the reverse (AUST R 167692).
ARAZIL 10 mg tablet is 9 mm white, film coated, round tablets embossed with "DL" over
"10" on one side and "G" on the reverse (AUST R 167693).
