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.
WARNING: Important safety information is provided in a boxed warning in the
full CMI. Read before using this medicine.
1. Why am I using ASPALGIN?
ASPALGIN contains the active ingredient aspirin and codeine phosphate hemihydrate.
ASPALGIN is used for the temporary relief of acute moderate pain, inflammation and
fever.
2. What should I know before I use ASPALGIN?
Do not use if you have ever had an allergic reaction to aspirin and codeine phosphate
hemihydrate 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 ASPALGIN and affect how it works.
4. How do I use ASPALGIN?
Your doctor will decide what dose you should receive.
The usual dose for adults and children over 12 years of age is 2 tablets dissolved
in water, every four hours or as directed.
5. What should I know while using ASPALGIN?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using ASPALGIN.
Tell your doctor immediately if you become pregnant or are breast-feeding while taking
ASPALGIN.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
ASPALGIN.
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Things you should not do
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Do not take ASPALGIN to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Do not stop taking your medicine or lower the dosage without checking with your doctor.
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Driving or using machines
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Be careful driving or operating machinery until you know how ASPALGIN affects you.
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Drinking alcohol
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You must not drink alcohol while using ASPALGIN.
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Looking after your medicine
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Keep the pack in a cool, dry place (below 25°C) in its original packaging.
Do not store ASPALGIN in the bathroom, near a sink, on a window sill or in the car.
Keep your tablets where children cannot reach it.
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6. Are there any side effects?
Tell your doctor or pharmacist if you notice any of the following and they worry you: nausea (feeling sick), constipation, dizziness, lethargy, drowsiness, sweating,
vomiting, skin rashes, runny nose, stomach pains, deafness, Reye’s Syndrome.
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WARNING:
Limitations of Use
ASPALGIN should only be used when your doctor decides that other treatment options
are not able to effectively manage your pain or you cannot tolerate them.
Hazardous and Harmful Use
ASPALGIN poses risks of abuse, misuse and addiction which can lead to overdose and
death. Your doctor will monitor you regularly during treatment.
Life Threatening Respiratory Depression
ASPALGIN can cause life-threatening or fatal breathing problems (slow, shallow, unusual
or no breathing), even when used as recommended. These problems can occur at any time
during use, but the risk is higher when first starting ASPALGIN and after a dose increase,
if you are older, or have an existing problem with your lungs. Your doctor will monitor
you and change the dose as appropriate.
Use of Other Medicines While Using ASPALGIN
Using ASPALGIN with other medicines that can make you feel drowsy such as sleeping
tablets (e.g. benzodiazepines), other pain relievers, antihistamines, antidepressants,
antipsychotics, gabapentinoids (e.g. gabapentin and pregabalin), cannabis and alcohol
may result in severe drowsiness, decreased awareness, breathing problems, coma and
death. Your doctor will minimise the dose and duration of use; and monitor you for signs
and symptoms of breathing difficulties and sedation. You must not drink alcohol while
using ASPALGIN.
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Active ingredient(s):
aspirin and codeine phosphate hemihydrate
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using ASPALGIN. 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 ASPALGIN.
Where to find information in this leaflet:
1. Why am I using ASPALGIN?
ASPALGIN contains the active ingredients aspirin and codeine phosphate hemihydrate. Aspirin belongs to a group of medicines called analgesics which are used to block
pain. It is also an antipyretic. That means it helps reduce your body temperature
if you have a fever. Codeine phosphate hemihydrate belongs to a group of medicines
called opioid analgesics and it acts by blocking pain and your emotional response
to pain.
ASPALGIN is used for the temporary relief of acute moderate pain, inflammation and
fever.
Addiction
You can become addicted to ASPALGIN even if you take it exactly as prescribed. ASPALGIN
may become habit forming causing mental and physical dependence. If abused it may
become less able to reduce pain.
Dependence
As with all other opioid containing products, your body may become used to you taking
ASPALGIN. Taking it may result in physical dependence. Physical dependence means that
you may experience withdrawal symptoms if you stop taking ASPALGIN suddenly, so it
is important to take it exactly as directed by your doctor.
Tolerance
Tolerance to ASPALGIN may develop, which means that the effect of the medicine may
decrease. If this happens, more may be needed to maintain the same effect.
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.
2. What should I know before I use ASPALGIN?
Warnings
Do not use ASPALGIN if:
you are allergic to aspirin, codeine phosphate hemihydrate or any of the ingredients
listed at the end of this 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
Always check the ingredients to make sure you can use this medicine.
you have a stomach ulcer
Elderly patients are more likely to have less effective kidney or liver function due
to age. This may increase the risk of side effects. You should discuss how much ASPALGIN
to take with your doctor or pharmacist.
the expiry date (EXP) printed on the pack has passed or 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.
Do not give this medicine to a child under the age of 12 years unless your doctor
has prescribed it for them.
Do not give to children or teenagers suffering viral illness (such as influenza or
chicken pox) or fever.
Do not give to children aged between 12 – 18 years in whom respiratory function might
be compromised, including post tonsillectomy and/or adenoidectomy for obstructive
sleep apnoea, due to an increased risk of developing serious and life-threatening
adverse reactions.
Aspirin has been implicated in cases of Reye’s Syndrome, a potentially fatal illness
which results from brain inflammation.
Check with your doctor if you:
are allergic to any other medicines, foods, dyes or preservatives
have had any of the following medical conditions:
liver disease, hepatitis
kidney disease
peptic ulcer
disorders of the gastrointestinal tract
asthma
bleeding disorders
inflammatory bowel disease
you are a heavy drinker or use drugs
you are about to have surgery under a general anaesthetic
you have recently had gastrointestinal tract or urinary tract surgery
you have had a recent head injury
Ask your doctor if you have a deficiency of liver enzymes that metabolise codeine
or if your liver enzymes metabolise codeine too rapidly.
If you have not told your doctor about any of the above, tell them before you start
taking ASPALGIN.
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.
Your doctor can discuss with you the risks and benefits involved.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Do not breast-feed if you are taking this medicine.
The active ingredients in ASPALGIN pass into the breast milk and there is a possibility
that your baby may be affected.
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 and ASPALGIN may interfere with each other.
These include:
medicines used to treat inflammation such as aspirin
medicines used to treat epilepsy
medicines used to treat gout
diuretics
hypnotics, sedatives or phenothiazines
These medicines may be affected by ASPALGIN 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 this medicine.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect ASPALGIN.
4. How do I use ASPALGIN?
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the box, ask your doctor or pharmacist
for help.
How much to take
Adults and children over 12 years of age:
2 tablets dissolved in water, to be taken every four hours or as directed.
DO NOT take more than 8 tablets in one day.
DO NOT give to children under 12 years of age unless on medical advice.
How to take it
Dissolve the tablets in a glass of water and then swallow the entire contents of the
glass.
When to take ASPALGIN
ASPALGIN should be taken at about the same time each day.
Taking it at the same time each day will have the best effect. It will also help you
remember when to take it.
It does not matter if you take this medicine before or after food.
How long to take it
Withdrawal
Continue taking your medicine for as long as your doctor tells you. If you stop taking
this medicine suddenly, your pain may worsen and you may experience some or all of
the following withdrawal symptoms:
nervousness, restlessness, agitation, trouble sleeping or anxiety
body aches, weakness or stomach cramps
loss of appetite, nausea, vomiting or diarrhoea
increased heart rate, breathing rate or pupil size
watery eyes, runny nose, chills or yawning
increased sweating
ASPALGIN given to the mother during labour can cause breathing problems and signs
of withdrawal in the newborn.
If you forget to use ASPALGIN
ASPALGIN should be used regularly at the same time each day.
If it is less than 4 hours before your next dose, skip the dose you missed and take
your next dose when you are meant to.
Otherwise, take it as soon as you remember, and then go back to taking your medicine
as you would normally.
Do not take a double dose to make up for the dose that 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 have trouble remembering to take your medicine, ask your pharmacist for some
hints.
If you use too much ASPALGIN
If you or someone else take too much (overdose), and experience one or more of the
symptoms below, immediately call triple zero (000) for an ambulance. Keep the person
awake by talking to them or gently shaking them every now and then. You should follow
the above steps even if someone other than you has accidentally taken ASPALGIN that
was prescribed for you. If someone takes an overdose they may experience one or more
of the following symptoms:
slow, unusual or difficult breathing
drowsiness, dizziness or unconsciousness
slow or weak heartbeat
nausea or vomiting
convulsions or fits
If you think you or someone else may have taken too much ASPALGIN, you should immediately:
phone the Poisons Information Centre
(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.
Depending on your body’s individual ability to break down codeine, you may experience
signs of overdose even when you take ASPALGIN as recommended by your doctor. If overdose
symptoms occur, seek immediate medical advice.
When seeking medical attention, take this leaflet and remaining medicine with you
to show the doctor. Also tell them about any other medicines or alcohol which have
been taken.
5. What should I know while using ASPALGIN?
Things you should do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking ASPALGIN.
Tell any other doctors, dentists and pharmacists who treat you that you are taking
this medicine.
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 needs to check your progress and to determine whether you need to continue
taking ASPALGIN.
Tell your doctor if you feel ASPALGIN is not helping your condition.
Things you should not do
Do not take ASPALGIN to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Do not stop taking your medicine or lower the dosage without checking with your doctor.
If you stop taking it suddenly, your condition may worsen.
Driving or using machines
Be careful driving or operating machinery until you know how ASPALGIN affects you.
This medicine may cause nausea, vomiting, constipation, drowsiness, dizziness in some
people. If you have any of these symptoms, do not drive, operate machinery or do anything
else that could be dangerous.
Drinking alcohol
Tell your doctor if you drink alcohol.
Be careful when drinking alcohol while you are taking this medicine.
If you drink alcohol, dizziness or light-headedness may be worse.
Looking after your medicine
Keep your tablets in the 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. Keep
the tablets in a dry place.
Do not store ASPALGIN or any other medicine in the bathroom or near a sink. Do not
leave it on a window sill or in the car.
Heat and dampness can destroy some medicines.
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.
Getting rid of any unwanted medicine
If your doctor tells you to stop taking this medicine or the expiry date has passed,
ask your pharmacist what to do with any medicine that is left over.
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.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking ASPALGIN.
This medicine helps most people with the temporary relief of acute moderate pain,
inflammation and fever, but it may have unwanted side effects in some people. All
medicines 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.
If you are over 65 years of age you may have an increased chance of getting 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.
Common side effects
The above list includes the more common side effects of your medicine.
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 ASPALGIN contains
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Active ingredient
(main ingredient)
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ASPALGIN contains 300 mg of aspirin and 8 mg of codeine phosphate hemihydrate
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Other ingredients
(inactive ingredients)
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calcium carbonate
citric acid
disodium edetate
purified talc
saccharin sodium
sodium lauryl sulfate
wheat starch
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Potential allergens
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ASPALGIN contains gluten and saccharin.
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Do not take this medicine if you are allergic to any of these ingredients.
What ASPALGIN looks like
ASPALGIN tablets are round, white and flat with bevelled edges with one side plain
and one side engraved FM having a diameter of 17/32". They are available in blister
packs of 40. (AUST R 13431).
Who distributes ASPALGIN
Viatris Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.viatris.com.au
Phone: 1800 274 276
This leaflet was prepared in April 2022.
ASPALGIN® is a Viatris company trade mark
ASPALGIN_cmi\Apr22/00