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.
Why am I taking APX-Paracetamol/Codeine?
APX-Paracetamol/Codeine contains the active ingredients paracetamol and codeine phosphate
hemihydrate. APX-Paracetamol/Codeine is used to relieve severe pain. For more information,
see Section
1. Why am I using APX-Paracetamol/Codeine? in the full CMI.
What should I know before I take APX-Paracetamol/Codeine?
Do not use if you have ever had an allergic reaction to APX-Paracetamol/Codeine 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. You may develop addiction, dependence and tolerance. For more information, see Section
2. What should I know before I use APX-Paracetamol/Codeine? in the full CMI.
What if I am taking other medicines?
How do I take APX-Paracetamol/Codeine?
The standard dose for adults is 1 or 2 tablets for severe pain, taken every 4 to 6
hours if necessary. More instructions can be found in Section
4. How do I use APX-Paracetamol/Codeine? in the full CMI.
What should I know while taking APX-Paracetamol/Codeine?
Are there any side effects?
Tell your doctor or pharmacist immediately if you notice any of the following side
effects 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. They
may be the signs of an allergic reaction.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
nausea or vomiting; constipation; drowsiness or dizziness. These are more common side
effects of your medicine. They are usually mild.
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.
|
WARNING:
Limitations of use
APX-Paracetamol/Codeine 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
APX-Paracetamol/Codeine 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
APX-Paracetamol/Codeine 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 APX-Paracetamol/Codeine
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 APX-Paracetamol/Codeine
Using APX-Paracetamol/Codeine with other medicines that can make you feel drowsy such
as sleeping tablets (e.g. benzodiazepines), other pain relievers, antihistamines,
antidepressants, antipsychotics, gabapentanoids (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 APX-Paracetamol/Codeine.
|
Active ingredient(s):
paracetamol and codeine phosphate hemihydrate
Consumer Medicine Information (CMI)
This leaflet provides important information about using APX-Paracetamol/Codeine. 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 APX-Paracetamol/Codeine.
Where to find information in this leaflet:
Why am I using APX-Paracetamol/Codeine?
APX-Paracetamol/Codeine contains the active ingredients paracetamol and codeine phosphate
hemihydrate.
Paracetamol and codeine work together to stop the pain messages from getting through
to the brain. Your doctor may have prescribed this medicine for another use.
APX-Paracetamol/Codeine is used to relieve severe pain for which other treatment options
have failed, are contraindicated, not tolerated or are otherwise inappropriate to
provide sufficient management of pain.
What should I know before I use APX-Paracetamol/Codeine?
Warnings
Do not use APX-Paracetamol/Codeine if:
you are allergic to paracetamol or codeine phosphate hemihydrate, or any of the ingredients
listed at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
you have acute breathing difficulties such as bronchitis, unstable asthma or emphysema
you have Glucose-6-phosphatedehydrogenase deficiency (an enzyme deficiency)
you are a CYP 2D6 ultra-rapid metaboliser (a fast metaboliser of codeine by the CYP
2D6 enzyme)
you have diarrhoea caused by antibiotics or poisoning
you have liver failure.
Do not take APX-Paracetamol/Codeine if you have a history of drug dependence, including
alcohol dependence.
Do not take APX-Paracetamol/Codeine if you have experienced systemic allergy (generalised
rash or shortness of breath) to morphine or oxycodone.
Do not take APX-Paracetamol/Codeine is you have a history of intolerance to paracetamol
and/or codeine.
Do not take APX-Paracetamol/Codeine if you are under 18 years of age and have had
your tonsils or adenoids removed to treat sleep apnoea.
Do not take APX-Paracetamol/Codeine during the third trimester of pregnancy.
Do not take APX-Paracetamol/Codeine during labour especially if the baby is premature.
Do not use APX-Paracetamol/Codeine if you are breastfeeding or planning to breastfeed.
Do not take this medicine after the expiry date (EXP) printed on the pack. If you take it after the expiry date it may have no effect at all, or worse, have
an entirely unexpected effect.
Do not take this medicine if the packaging is torn or shows signs of tampering.
Do not use this medicine to treat any other complaint unless your doctor says it is
safe.
APX-Paracetamol/Codeine is not recommended for children under 12 years.
Check with your doctor if you have or have had any of the following medical conditions:
lung, heart, liver or kidney problems
low blood pressure
difficulty breathing, wheezing, chronic cough, asthma, or other chronic breathing
conditions
a history of drug dependence, including alcohol dependence
you drink large quantities of alcohol
recent cessation of alcohol intake
low glutathione reserves
Gilbert's syndrome
gall bladder problems or your gall bladder has been removed
multiple sclerosis
recent stomach, intestine or urinary tract surgery
irritable bowel syndrome or other bowel problems
prostate problems
under active thyroid gland or problems with your adrenal glands
fits or seizures
head injury
brain tumours.
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.
Do not take APX-Paracetamol/Codeine during the third trimester of pregnancy.
Do not take APX-Paracetamol/Codeine during labour, especially if the baby is premature.
This medicine can cause breathing problems and may produce withdrawal effects in the
newborn baby.
Do not take APX-Paracetamol/Codeine if you are breastfeeding planning to breastfeed.
The medicine passes into breast milk and may affect the baby.
Addiction
You can become addicted to APX-Paracetamol/Codeine even if you take it exactly as
prescribed. APX-Paracetamol/Codeine 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
APX-Paracetamol/Codeine. Taking it may result in physical dependence. Physical dependence
means that you may experience withdrawal symptoms if you stop taking APX-Paracetamol/Codeine
suddenly, so it is important to take it exactly as directed by your doctor.
Tolerance
Tolerance to APX-Paracetamol/Codeine may develop, which means that the effect of the
medicine may decrease. If this happens, more may be needed to maintain the same effect.
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 APX-Paracetamol/Codeine and affect how it works.
These include:
any medicine causing sleepiness or drowsiness
tranquillisers (medicines for anxiety and nerves)
benzodiazepines (medicines used as sedatives or to treat anxiety)
medicines used to treat alcohol and/or opioid dependence (e.g. naltrexone, buprenorphine
or methadone)
medicines containing alcohol (ethanol), e.g. some cough syrups
cough suppressants or antitussives
antihistamines (medicines used to treat allergies)
medicines used to treat depression
medicines used to treat mental illness
monoamine oxidase inhibitors (medicines used to treat depression) taken within the
last 10 days
salicylates or non-steroidal antiinflammatory drugs (NSAIDS), such as aspirin or ibuprofen
medicines which thin the blood
medicines to treat epilepsy
other pain relief medication
medicines used to treat high blood pressure
medicines used to relax muscles
medicines used to treat diarrhoea, nausea or vomiting
propantheline, a drug used to treat stomach ulcers
cholestyramine (medicine used to treat bile problems and/or high cholesterol
chelating resin
chloramphenicol (antibiotic used to treat ear and eye infections)
flucloxacillin, zidovudine or rifampicin (medicines used to treat infections)
medicines used to control electrolytes levels in kidney disease
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect APX-Paracetamol/Codeine.
How do I take APX-Paracetamol/Codeine?
How much to take
The recommended dose of APX-Paracetamol/Codeine is:
Adults: 1 or 2 tablets for severe pain. This dosage may be repeated in 4-6 hours if
necessary.
Follow the instructions provided.
Do not take more than 8 tablets in 24 hours.
Do not take more than the recommended dose.
Taking more than the recommended dose may cause liver damage.
The directions given to you by your doctor or pharmacist may be different from the
information in this leaflet. If you are unsure what dose to take ask your pharmacist
or doctor.
Talk to your doctor about pain control if the medicine is not helping.
Depending on your body's individual ability to break down codeine, you may be getting
reduced benefit or experience signs of overdose even when you take APX-Paracetamol/Codeine
as recommended by your doctor. If overdose symptoms occur, seek immediate medical
advice.
How to take APX-Paracetamol/Codeine
Swallow the tablets with water.
How long to take it for
Ask your doctor or pharmacist if you are not sure how long to take the medicine for.
If you forget to take APX-Paracetamol/Codeine
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
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 pharmacist or doctor.
If you have trouble remembering to take your medicine, ask your pharmacist for some
hints.
If you take too much APX-Paracetamol/Codeine
If you or someone else receive 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 have accidentally used APX-Paracetamol/Codeine
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 that you have used too much APX-Paracetamol/Codeine, 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.
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.
What should I know while taking APX-Paracetamol/Codeine?
Things you should do
Take APX-Paracetamol/Codeine exactly as your doctor has prescribed.
Tell your doctor if you become pregnant while taking APX-Paracetamol/Codeine.
Remind any doctor, dentist or pharmacist you visit that you are using APX-Paracetamol/Codeine.
Things you should not do
Do not take more than the recommended dose unless your doctor tells you to.
Adults should not take more than 8 tablets a day.
Do not take high doses of the medicine for long periods of time unless you doctor
tells you to.
Taking more than the recommended dose can cause liver damage.
APX-Paracetamol/Codeine may be habit forming if taken in high doses for extended periods
of time.
Do not give this medicine to anyone else.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how APX-Paracetamol/Codeine
affects you.
APX-Paracetamol/Codeine may cause dizziness, light-headedness, drowsiness and problems
with vision in some people, especially after the first dose.
Children should not ride bikes if affected and should be supervised to avoid potential
harm.
Drinking alcohol
Do not drink alcohol while taking APX-Paracetamol/Codeine.
Drinking alcohol increases the likelihood of becoming drowsy.
Withdrawal
Continue taking your medicine for as long as your doctor tells you. If you stop having
this medicine suddenly, your pain may worsen and you may experience some or all of
the following withdrawal symptoms:
Nervousness, restlessness, agitations, 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
Looking after your medicine
Store 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.
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.
Less serious side effects
|
Less serious side effects
|
What to do
|
|
Gastrointestinal related:
nausea or vomiting
indigestion
constipation
stomach pain
Head and neurology related:
dry mouth
drowsiness or sleepiness
headache
ringing in the ears
Skin related:
sweating
|
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
|
|
Allergy related:
shortness of breath, wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
skin rash, itching or hives on the skin
flushing of the face
Heart related:
fast heartbeat
Skin related:
severe blisters and bleeding in the lips, eyes, mouth, nose and genitals
painful red areas with blisters and peeling layers of skin which may be accompanied
by fever and/or chills
yellowing of the skin and eyes (jaundice)
Infection related:
mouth ulcers, fever and sore throat
Bleeding related:
bleeding, bruising more easily
Head and neurology related:
dizziness, light-headedness
unusual or extreme mood swings
confusion
seizures
Liver related:
hepatitis (symptoms include loss of appetite, itching, yellowing of the skin and eyes,
light coloured bowel motions, dark coloured urine)
Urinary related:
problems passing urine
dark coloured urine
Eyes related:
blurred vision.
Metabolism related:
Symptoms of rapid breathing, rapid heart rate and changes in consciousness caused
by pyroglutamic acidosis (an accumulation of pyroglutamic acid due to low levels of
a protein called glutathione).
|
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.
Product details
This medicine is only available with a doctor's prescription.
What APX-Paracetamol/Codeine contains
Do not take this medicine if you are allergic to any of these ingredients.
What APX-Paracetamol/Codeine looks like
APX-Paracetamol/Codeine is a white to off-white capsule-shaped tablet, marked “P”
and “F” either side of a score line on one side and plain on the other (AUST R 338093).
It comes in boxes of 10 or 20 tablets.
*Not all pack sizes may be marketed
Who distributes APX-Paracetamol/Codeine
Arrotex Pharmaceuticals Pty Ltd
15-17 Chapel Street
Cremorne, VIC, 3121
Australia
Toll Free Number (medical information): 1800 195 055
This leaflet was prepared in December 2021.
apx-para-cod-ccdsv5-cmiv3-03dec21