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 APO-DONEPEZIL?
APO-DONEPEZIL contains the active ingredient donepezil hydrochloride. APO-DONEPEZIL 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 APO-DONEPEZIL? in the full CMI.
2. What should I know before I use APO-DONEPEZIL?
Do not use if you have ever had an allergic reaction to APO-DONEPEZIL 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 APO-DONEPEZIL? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with APO-DONEPEZIL 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.
4. How do I use APO-DONEPEZIL?
- The usual starting dose is one APO-DONEPEZIL 5 mg tablet each day
- After one month, your doctor will assess your response and may increase your dose to one APO-DONEPEZIL 10 mg tablet each day.
More instructions can be found in Section 4. How do I use APO-DONEPEZIL? in the full CMI.
5. What should I know while using APO-DONEPEZIL?
| Things you should do |
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| Things you should not do |
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| Driving or using machines |
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| Looking after your medicine |
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For more information, see Section 5. What should I know while using APO-DONEPEZIL? in the full CMI.
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.
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.
APO-DONEPEZIL
Active ingredient(s): donepezil hydrochloride (doe-knee-pra-zeal hi-dro-claw-ride)
Consumer Medicine Information (CMI)
This leaflet provides important information about using APO-DONEPEZIL. 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 APO-DONEPEZIL.
Where to find information in this leaflet:
1. Why am I using APO-DONEPEZIL?
2. What should I know before I use APO-DONEPEZIL?
3. What if I am taking other medicines?
4. How do I use APO-DONEPEZIL?
5. What should I know while using APO-DONEPEZIL?
6. Are there any side effects?
7. Product details
1. Why am I using APO-DONEPEZIL?
APO-DONEPEZIL contains the active ingredient donepezil hydrochloride. APO-DONEPEZIL is an acetylcholinesterase inhibitor. They are thought to work by increasing the level of a chemical called acetylcholine in the brain.
APO-DONEPEZIL is used to treat mild, moderate and severe Alzheimer’s disease, also called dementia of the Alzheimer’s type. APO-DONEPEZIL 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 APO-DONEPEZIL?
Warnings
Do not use APO-DONEPEZIL 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
- 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 if you are breastfeeding or intend to breastfeed.
Children
APO-DONEPEZIL is not recommended for use in children.
The safety and effectiveness of APO-DONEPEZIL 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 APO-DONEPEZIL 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 APO-DONEPEZIL.
4. How do I use APO-DONEPEZIL?
How much to take
- the usual starting dose for APO-DONEPEZIL is one 5 mg tablet each day.
- after 1-month, your doctor will assess your response and may increase your dose to one APO-DONEPEZIL 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 / use APO-DONEPEZIL
- 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 APO-DONEPEZIL
- Swallow the tablets whole with a full glass of water.
- APO-DONEPEZIL 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 APO-DONEPEZIL
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 APO-DONEPEZIL
If you think that you have used too much APO-DONEPEZIL, 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 APO-DONEPEZIL?
Things you should do
Remind any doctor, dentist or pharmacist you visit that you are using APO-DONEPEZIL.
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 APO-DONEPEZIL 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 young children cannot reach it.
Getting rid of any unwanted 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 about side effects.
Common side effects
| Less serious side effects | What to do |
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Speak to your doctor if you have any of these less serious side effects and they worry you. |
Serious side effects
| Serious side effects | What to do |
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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. |
Very serious side effects
| Very serious side effects | What to do |
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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. |
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 APO-DONEPEZIL contains
| Active ingredient (main ingredient) |
donepezil hydrochloride |
| Other ingredients (inactive ingredients) |
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| Potential allergens | Contains sugars as lactose. |
Do not take this medicine if you are allergic to any of these ingredients.
What APO-DONEPEZIL looks like
APO-DONEPEZIL 5 mg: White to off-white, circular, biconvex, film coated tablets embossed with “C” on one side and “7” on the other side. (AUST R 213495)
APO-DONEPEZIL 10 mg: Yellow, circular, biconvex, film-coated tablets embossed with “C” on one side and “6” on the other side (AUST R 213496)
APO-DONEPEZIL are presented in blister packs containing 28 tablets.
Who distributes APO-DONEPEZIL
Arrotex Pharmaceuticals Pty Ltd
15 – 17 Chapel Street
Cremorne, 3121 Victoria
Australia
This leaflet was prepared in August 2023
Published by MIMS September 2023