NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
ARAZIL
Donepezil hydrochloride
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common questions about ARAZIL
It does not contain all the available information.It does not take the place of talking to your doctor or pharmacist.
All medicines have benefits and risks.Your doctor has weighed the risks of you taking ARAZIL against the benefits expected for you.
If you have any concerns about taking this medicine, talk to your doctor or pharmacist.
Keep this leaflet with your medicine.
You may need to read it again.
What ARAZIL is used for
ARAZIL tablets are used to treat mild, moderate and severe Alzheimer’s disease, also called dementia of the Alzheimer’s type.
ARAZIL will not cure this disease, but should help your memory and improve your thinking capacity.
This medicine belongs to a group of medicines called acetylcholinesterase inhibitors. They are thought to work by increasing the level of a chemical called acetylcholine in the brain.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason.
This medicine is not addictive.
This medicine is only available with a doctor’s prescription.
Before you take ARAZIL
When you must not take it
Do not take ARAZIL if you have an allergy to:
any medicine containing donepezil hydrochloride
piperidine derivatives
any of the ingredients listed at the end of the leaflet.
Some of the symptoms of an allergic reaction may include
shortness of breath,
wheezing or difficulty breathing;
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin
Do not give ARAZIL to children.
Do not take this medicine if you are pregnant unless advised by your doctor.
It may affect your developing baby if you take it during pregnancy.
Do not breast-feed if you are taking this medicine.
The active ingredient in ARAZIL passes into breast milk and there is a possibility that your baby may be affected.
The safety and effectiveness of ARAZIL in children have not been established.
Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you plan to go to hospital for surgery that requires a general anaesthetic.
Tell your doctor if you have or have had any of the following medical conditions:
heart problems
stomach problems, particularly gastric or duodenal ulcer
seizures or fits (epilepsy)
asthma or obstructive pulmonary disease
loss of memory or other mental capacity due to stroke or blood vessel problems
a tendency towards aggressive behaviour.
Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding.
Your doctor can discuss with you the risks and benefits involved.
If you have not told your doctor about any of the above, tell him/her before you start taking ARAZIL.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from a pharmacy, supermarket or health food shop.
Some medicines and ARAZIL may interfere with each other. These include:
any other medicine for dementia
some medicines used to relieve stomach cramps or spasms, Parkinson’s disease or travel sickness
some medicines used to treat difficulty in passing urine
non-steroidal anti-inflammatory drugs (NSAIDs) -medicines used to treat arthritis, pain or inflammation
some medicines used to relax muscles
some medicines used to treat high blood pressure or fast hear beat
some medicines used to treat irregular heart beat such as quinidine
some medicines for treating asthma, diarrhoea, depression, schizophrenia and related mental conditions, or used in general anaesthesia
carbamazepine, phenobarbital (phenobarbitone) or phenytoin, medicines used to treat epilepsy
ketoconazole, a medicine used to treat fungal infections
rifampicin, an antibiotic used to treat tuberculosis
dexamethasone, a corticosteroid medicine.
These medicines may be affected by ARAZIL or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking ARAZIL.
How to take ARAZIL
Follow all directions given to you by your doctor and pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the packaging, ask your doctor or pharmacist for help.
How much to take
The usual starting dose for ARAZIL is one 5 mg tablet each day.
After 1 month, your doctor will assess your response and may increase your dose to one 10 mg tablet a day.
However, depending on your condition and how you react to the medicine, your doctor may ask you to take some other dose.
How to take it
Swallow the tablets whole with a full glass of water.
Do not divide the tablet into halves.
When to take it
Take the tablet 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.
ARAZIL can be taken with or without food.
How long to take it
Continue taking your medicine for as long as your doctor tells you to.
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 ARAZIL to take effect, so do not be discouraged if you do not see an improvement straight away.
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 it 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 take too much (Overdose)
Immediately telephone your doctor or the Australian Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital, if you think you or anyone else may have taken too much ARAZIL. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
Symptoms of an overdose may include:
feeling sick in the stomach
vomiting
increased sweating or saliva production
slow heart beat
feeling dizzy or faint
difficulty breathing
seizures or fits
feeling weak
unable to control your bowel motions or passing of urine (incontinence).
While you are taking ARAZIL
Tell all doctor, dentists and pharmacists who are treating you that you are taking ARAZIL.
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking 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.Your doctor may ask you to stop taking ARAZIL a few days before you have surgery.
Tell your doctor immediately if you become pregnant while taking ARAZIL.
If you are a woman of child-bearing age, you should avoid becoming pregnant while taking ARAZIL.
Keep all of your doctor’s appointments so that your progress can be checked.
Your doctor may do some tests form time to time to make sure the medicine is working and to prevent unwanted side effects.
Things you must not do
Do not give this medicine to anyone else, even if they have the same condition as you.
Do not use ARAZIL to treat any other complaints unless your doctor tells you to.
Things to be careful of
Be careful driving or operating machinery until you know how ARAZIL affects you.
This medicine may cause fatigue, dizziness and muscle cramps especially at the start of treatment or when 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.
Side effects
Tell your doctor as soon as possible if you do not feel well while you are taking ARAZIL.
This medicine helps most people with Alzheimer’s disease, but it may have unwanted side effects in a few people.
All medicines can have side effects.Sometimes they are serious, most of the time they are not.You may need medical attention if you get some of the side effects.
Do not be alarmed by the following lists of side effects.
You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
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.
The above list includes the more common side effects of your medicine.They are usually mild and short-lived.
Tell your doctor as soon as possible if you notice any of the following:
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
severe upper stomach pain, often with nausea, vomiting and fever.
The above list includes serious side effects which may require medical attention.
If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
any breathing problems
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 heart beat
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).
The above list includes very serious side effects.You may need urgent medical attention or hospitalization.
Tell your doctor if you notice anything else that is making you feel unwell.
Other side effects not listed above may also occur in some people.
After taking ARAZIL
Storage
Keep it where children cannot reach it.
A locked cupboard at least one and a half metres above the ground is a good place to store medicines.
Keep ARAZIL in a cool, dry place where the temperature stays below 25°C.
Do not store it or any other medication in the bathroom or near a sink.Do not leave it in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep your tablets in their origin pack until it is time to take them.
If you take the tablets out of the pack they may not keep well.
Disposal
If your doctor tells you to stop taking ARAZIL, or the tablets have passed their expiry date, ask your pharmacist what to do with any left over.
Product description
What it looks like
ARAZIL 5 mg tablets – 7 mm white, film coated, round tablets embossed with “DL over 5” on one side and “G” on the reverse.
ARAZIL 10 mg tablets – 9 mm white, film coated, round tablets embossed with “DL over 10” on one side and “G” on the reverse.
ARAZIL is available in either blister packs or bottle containing a pack size of 28 tablets.
Active ingredients
ARAZIL 5 mg – 5 mg donepezil hydrochloride/tablet. (Each tablet contains 4.56 mg donepezil)
ARAZIL 10 mg – 10 mg donepezil hydrochloride/tablet. (Each tablet contains 9.12 mg donepezil)
Other ingredients
The tablets also contain the following inactive ingredients:
lactose monohydrate
maize starch
Hyprolose
microcrystalline cellulose
magnesium stearate
Opadry white Y-1-7000 (ID no. 1475)
Supplier
ARAZIL is supplied by:
Alphapharm Pty Limited
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.mylan.com.au
Australian registration numbers:
ARAZIL 5 mg tablet blister pack
– AUST R 167692
ARAZIL 5 mg tablet bottle
– AUST R 167695
ARAZIL 10 mg tablet blister pack
– AUST R 167693
ARAZIL 10 mg tablet bottle
– AUST R 167694
This leaflet was prepared on
September 2019.
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