aspirin and codeine phosphate hemihydrate
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about ASPALGIN. It does not contain all
the available information. It does not take the place of talking to your doctor or
All medicines have risks and benefits. Your doctor has weighed the risks of you taking
ASPALGIN against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What ASPALGIN is used for
This medicine is used for the temporary relief of acute moderate pain, inflammation
This medicine 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.
Ask your doctor if you have any questions about why this medicine has been prescribed
Your doctor may have prescribed it for another reason.
Before you take ASPALGIN
When you must not take it
Do not take ASPALGIN if you have an allergy to:
any medicine containing aspirin or codeine phosphate hemihydrate
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
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.
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
Aspirin has been implicated in cases of Reye’s Syndrome, a potentially fatal illness
which results from brain inflammation.
Do not take ASPALGIN if 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.
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 or any foods, dyes or
Tell your doctor if you have had any of the following medical conditions:
liver disease, hepatitis
disorders of the gastrointestinal tract
inflammatory bowel disease
Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.
Your doctor can discuss with you the risks and benefits involved.
Tell your doctor if:
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 other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any
that you get without a prescription from your pharmacy, supermarket or health food
Some medicines and ASPALGIN may interfere with each other.
medicines used to treat inflammation such as aspirin
medicines used to treat epilepsy
medicines used to treat gout
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.
How to take 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
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
When to take it
Take your medicine 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
Continue taking your medicine for no more than a few days at a time unless your doctor
has advised you to.
If you forget to take it
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
If you take too much (overdose)
Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26)
for advice, or go to Accident and Emergency at the nearest hospital, if you think
that you or anyone else may have taken too much ASPALGIN. Do this even if there are
no signs of discomfort or poisoning. Also report any other medicine or alcohol (including
any barbiturates or narcotics) which may have been taken.
You may need urgent medical attention.
If you take too much ASPALGIN you may have symptoms of weakness, dizziness, lethargy,
drowsiness, nausea, vomiting, sweating, tinnitus (ringing in the ears), deafness and
While you are using ASPALGIN
Things you must 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
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
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
Tell your doctor if you feel ASPALGIN is not helping your condition.
Things you must 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
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.
Things to be careful of
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.
Be careful when drinking alcohol while you are taking this medicine.
If you drink alcohol, dizziness or light-headedness may be worse.
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
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:
nausea (feeling sick)
Reye’s Syndrome (refer to previous comments on use in children and teenagers)
The above list includes the more common side effects of your medicine.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may also occur in some people.
After using ASPALGIN
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.
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.
What it looks like
ASPALGIN tablets are round and white with bevelled edges and marked with FM on one
ASPALGIN is available in blister packs of 40.
ASPALGIN contains 300 mg of aspirin and 8 mg of codeine phosphate hemihydrate as the
The tablets also contain the following ingredients:
sodium lauryl sulfate
The tablets also contain gluten and saccharin.
Mylan Health Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 314 527
This leaflet was prepared in January 2020.
AUST R 13431.