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 taking Prodeine Forte?
Prodeine Forte contains the active ingredients paracetamol and codeine phosphate hemihydrate.
Prodeine Forte is used to relieve severe pain. For more information, see Section
1. Why am I using Prodeine Forte? in the full CMI.
2. What should I know before I take Prodeine Forte?
Do not use if you have ever had an allergic reaction to Prodeine Forte 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.
3. What if I am taking other medicines?
Some medicines may interfere with Prodeine Forte and affect how it works.
4. How do I take Prodeine Forte?
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 Prodeine Forte? in the full CMI.
5. What should I know while using Prodeine Forte?
6. 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.
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WARNING:
Limitations of use
Prodeine Forte 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
Prodeine Forte 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
Prodeine Forte 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 Prodeine forte 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 Prodeine Forte
Using Prodeine Forte 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 Prodeine Forte.
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Active ingredient(s):
paracetamol and codeine phosphate hemihydrate
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Prodeine Forte. 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 Prodeine Forte.
Where to find information in this leaflet:
1. Why am I taking Prodeine Forte?
Prodeine Forte 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.
Prodeine Forte 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.
2. What should I know before I take Prodeine Forte?
Warnings
Do not use Prodeine Forte 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 Prodeine Forte if you have a history of drug dependence, including alcohol
dependence.
Do not take Prodeine Forte if you have experienced systemic allergy (generalised rash
or shortness of breath) to morphine or oxycodone.
Do not take Prodeine Forte if you have a history of intolerance to paracetamol and/or
codeine.
Do not take Prodeine Forte if you are under 18 years of age and have had your tonsils
or adenoids removed to treat sleep apnoea.
Do not take Prodeine Forte during the third trimester of pregnancy.
Do not take Prodeine Forte during labour especially if the baby is premature.
Do not use Prodeine Forte 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.
Prodeine Forte 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 Prodeine Forte during the third trimester of pregnancy.
Do not take Prodeine Forte 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 Prodeine Forte if you are breastfeeding or planning to breastfeed.
The medicine passes into breast milk and may affect the baby.
Addiction
You can become addicted to Prodeine Forte even if you take it exactly as prescribed.
Prodeine Forte 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
Prodeine Forte. Taking it may result in physical dependence. Physical dependence means
that you may experience withdrawal symptoms if you stop taking Prodeine Forte suddenly,
so it is important to take it exactly as directed by your doctor.
Tolerance
Tolerance to Prodeine Forte may develop, which means that the effect of the medicine
may decrease. If this happens, more may be needed to maintain the same effect.
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 Prodeine Forte 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 Prodeine Forte.
4. How do I take Prodeine Forte?
How much to take
The recommended dose of Prodeine Forte 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 Prodeine Forte
as recommended by your doctor. If overdose symptoms occur, seek immediate medical
advice.
How to take Prodeine Forte
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 use Prodeine Forte
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 Prodeine Forte
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 Prodeine
Forte 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 or someone else have used too much Prodeine Forte, 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.
5. What should I know while using Prodeine Forte?
Things you should do
Take Prodeine Forte exactly as your doctor has prescribed.
Tell your doctor if you become pregnant while taking Prodeine Forte.
Remind any doctor, dentist or pharmacist you visit that you are using Prodeine Forte.
If your pain gets worse after you take this medicine do not take more without first
talking to your doctor.
Talk to your doctor, if the pain that you have increases, if you feel more sensitive
to pain, or if you have new pain after taking this medicine.
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 your doctor
tells you to.
Taking more than the recommended dose can cause liver damage.
Prodeine Forte 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 Prodeine
Forte affects you.
Prodeine Forte 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 Prodeine Forte.
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. 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 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.
Less serious side effects
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 Prodeine Forte contains
Do not take this medicine if you are allergic to any of these ingredients.
What Prodeine Forte looks like
Prodeine Forte is available as white to off-white capsule-shaped tablets, marked “P”
and “F” either side of a score line on one side and plain on the other (AUST R 93865).
It comes in boxes of 20 tablets.
Who distributes Prodeine Forte
Distributed by:
Winthrop Pharmaceuticals
Division of sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Freecall: 1800 818 806
Email:
[email protected]
This leaflet was prepared in August 2024.
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