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 Prodeine?
Prodeine contains the active ingredients paracetamol and codeine phosphate hemihydrate.
Prodeine is used to relieve acute moderate pain and fever.
2. What should I know before I use Prodeine?
Do not use if you have ever had an allergic reaction to Prodeine 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 Prodeine and affect how it works.
4. How do I use Prodeine?
Adults and children 12 years or over:
One or two tablets every 3 to 4 hours as needed for relief. Do not take more than
8 caplets in 24 hour period
5. What should I know while using Prodeine?
6. Are there any side effects?
Prodeine may be habit forming if taken frequently or over long periods. Tell your
doctor or pharmacist if you notice any of the following and they worry you: nausea
or vomiting; drowsiness or dizziness; constipation; stomach pain; skin rashes; sweating.
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
Prodeine should only be used if your doctor decides other treatment options are not
able to effectively manage your pain or you cannot tolerate them.
Hazardous and harmful use
Prodeine contains codeine which may be habit forming. Prodeine poses risks of abuse,
misuse and addiction which can lead to overdose and death. Your doctor will assess
your risks and monitor you regularly during treatment.
Life threatening respiratory depression
Serious, life-threatening, or fatal respiratory depression (shallow or difficulty
breathing) may occur with the use of Prodeine even when used as recommended. These
problems can occur at any time during use, but the risk is higher when first starting
Prodeine 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
Using Prodeine 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 minimize the dose and duration of use and monitor you regularly
for signs and symptoms of breathing difficulties and sedation. You must not drink
alcohol while taking Prodeine.
|
Active ingredient(s):
paracetamol and codeine phosphate hemihydrate
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Prodeine. 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.
Where to find information in this leaflet:
1. Why am I using Prodeine?
Prodeine is a type of analgesic intended for short term use to relieve acute moderate
pain and fever.
Prodeine contains the active ingredients paracetamol and codeine phosphate hemihydrate.
Codeine phosphate hemihydrate belongs to a group of medicines called analgesics. It
is an opioid analgesic and it acts by blocking pain and your emotional response to
pain.
Paracetamol works to stop the pain messages from getting through to the brain. It
also acts in the brain to reduce fever.
Paracetamol and codeine work together to stop the pain messages from getting through
to the brain.
Prodeine is for the short term relief of acute moderate pain and fever.
2. What should I know before I use Prodeine?
Warnings
Do not use Prodeine 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 are allergic to aspirin or anti-inflammatory medications
you have severe and/or acute respiratory diseases
you have acute breathing difficulties such as bronchitis, unstable asthma, emphysema
(serious lung disease), respiratory depression (shallow breathing) or respiratory
insufficiency (difficulty breathing).
you have a Glucose-6-phosphate dehydrogenase deficiency (an enzyme deficiency)
you are an ultra-rapid metaboliser of CYP 2D6 (a fast metaboliser of codeine by the
CYP 2D6 enzyme)
you have had your tonsils or adenoids removed and are aged between 12 and 18 years
of age
you have severe liver or kidney disease
you are suffering from diarrhea caused by poisoning or antibiotics
you have chronic constipation
Do not take codeine if you have a history of drug dependence, including alcohol dependence.
Do not give Prodeine to children under 12 years of age.
Do not take Prodeine during the third trimester of pregnancy.
Do not take it during labour, especially if the baby is premature.
Do not take it 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 has passed, it may not work as well.
Do not take this medicine if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
Check with your doctor if you:
plan to have surgery
have difficulty breathing, experience wheezing, chronic cough, asthma or other chronic
breathing conditions.
have any form of problems with breathing as a result of emphysema, kyphoscoliosis
or obesity
have a known analgesic intolerance
have or have had heart, liver or kidney problems
underactive thyroid
have a history of drug dependence, including alcohol dependence
experience chronic alcohol use including recent cessation of alcohol intake
have a pre-existing opioid dependence
have low glutathione reserves
have Gilbert's syndrome
have had recent surgery of the stomach or intestine
have prostate problems
have multiple sclerosis
have low blood pressure
have had a head injury or trauma
have urinary, bowel or gallbladder conditions
have chronic constipation
have problems with the adrenal glands
have myasthenia gravis, a muscle disorder
have convulsions, fits or seizures
if you know you are a CYP 2D6 ultra-rapid metaboliser
Tell your doctor or pharmacist about anything listed above before you start taking Prodeine.
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. Prodeine passes
into breast milk and there is a possibility your baby may be affected.
Do not take Prodeine during the third trimester of pregnancy.
Do not take Prodeine during labour, especially if the baby is premature.
This may produce withdrawal effects in the newborn baby.
If you are over 65 years of age
Talk to your doctor or pharmacist about how much to take.
Elderly patients are more likely to have less effective kidney function due to age.
This may increase the risk of side effects.
Addiction
You can become addicted to Prodeine even if you take it exactly as prescribed. Prodeine
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. Taking it may result in physical dependence. Physical dependence means that
you may experience withdrawal symptoms if you stop taking Prodeine suddenly, so it
is important to take it exactly as directed by your doctor.
Tolerance
Tolerance to Prodeine may develop, which means that the effect of the medicine may
decrease. If this happens, more may be needed to maintain the same effect.
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, 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.
Prodeine given to the mother during labour can cause breathing problems and signs
of withdrawal in the newborn.
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 the absorption of Prodeine. These include:
medicines used to help relax, sleep or relieve anxiety, such as barbiturates, sedatives,
tranquillisers, hypnotics, gabapentinoids, cannabis and centrally-active anti-emetics
benzodiazepines (medicines used as sedatives or to treat anxiety)
medicines containing alcohol (ethanol), e.g. some cough syrups
antihistamines (medicines used to treat allergies)
medicines used to treat epilepsy or fits
medicines which thin the blood such as warfarin
other opioid analgesics used to treat pain
monoamine oxidase inhibitors, medicine used to treat depression, taken within the
last 14 days
flucloxacillin, zidovudine or rifampicin, medicines used to treat infections
metoclopramide or domperidone, medicines used to control nausea and vomiting
quinidine, a medicine used to treat abnormal or irregular heartbeat
phenothiazines and antipsychotic agents, medicines used to treat mental disorders
medicines used to treat depression
chloramphenicol, an antibiotic used to treat ear and eye infection
medicines used to relieve stomach cramps or spasms, to prevent travel sickness and
to treat Parkinson's disease
medicines used to treat high blood pressure
cholestyramine, a medicine used to lower high cholesterol levels
chelating resin
medicines used to treat alcohol and/or opioid dependence (e.g. naltrexone, buprenorphine
or methadone)
medicines for diarrhoea, such as kaolin, pectin and loperamide
medicines used to control electrolytes levels in kidney disease
These medicines may be affected by Prodeine or may affect how well Prodeine works.
You may need to use different amounts of your medicine, or take different medicines.
Your pharmacist or doctor will advise you.
Your doctor or pharmacist will have more information on medicines to be careful with
or avoid while taking Prodeine.
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.
4. How do I use Prodeine?
How much to take
Adults and children 12 years or over:
One or two tablets every 3 to 4 hours as needed for relief.
Do not take more than 8 caplets in 24 hour period
Follow the instructions provided and use Prodeine until your doctor tells you to stop.
When to take Prodeine
Prodeine should be used for the temporary relief of acute moderate pain and fever
as per the instructions given to you by your doctor.
Prodeine is not recommended for children under 12 years of age.
Prodeine is not recommended for use over an extended period of time.
Do not take more than the recommended dose.
How to take Prodeine
Swallow the tablets whole with a full glass of water or other liquid.
Prodeine can be taken with or without food.
If you forget to use Prodeine
Prodeine should be used exactly as your doctor has instructed.
You may take Prodeine as soon as you remember or if you think you need it.
Do not take a double dose to make up for the dose you have missed.
This may increase the chance of getting unwanted side effect.
If you are not sure what to do, ask your pharmacist or doctor.
If you take too much Prodeine
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
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 taken too much Prodeine, 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.
Large amounts of paracetamol, one of the active ingredients, can cause liver damage.
Children who take too much Prodeine can also suffer extreme drowsiness, rash or have
trouble seeing.
Depending on your body’s individual ability to break down codeine, you may experience
signs of overdose even when you take Prodeine as recommended by your doctor. If overdose
symptoms occur, seek immediate medical advice.
5. What should I know while using Prodeine?
Things you should do
Tell your doctors, dentists and pharmacists who are treating you that you are taking
Prodeine.
If you are about to be started on any new medicine, tell your pharmacist or doctor
that you are taking Prodeine.
If you plan to have surgery that needs a general anaesthetic, tell your doctor or
dentist that you are taking this medicine.
Talk to your pharmacist or doctor about pain control if Prodeine is not helping.
Your pharmacist or doctor will assess your condition and decide if you should continue
to take Prodeine.
Things you should not do
Children:
Do not give this medicine to children under 12 years of age
Do not give this medicine for more than 48 hours unless a doctor tells you.
Adults:
Do not take more than a few days at a time unless your doctor tells you to.
Do not take more than the recommended dose unless your pharmacist or doctor tells
you to.
Do not give this medicine to anyone else, even if they have the same condition as
you.
Do not use this medicine to treat any other complaints unless your pharmacist or doctor
tells you to.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Prodeine
affects you.
Prodeine may cause drowsiness in some people. If this happens, do not drive or operate
machinery.
Drinking alcohol
Tell your doctor if you drink alcohol.
Do not drink while taking Prodeine.
Drinking large quantities of alcohol while taking Prodeine may increase the risk of
liver side effects due to paracetamol.
Looking after your medicine
Store below 30° C.
Follow the instructions in the carton on how to take care of your medicine properly.
Keep your tablets in the blister pack until it’s time to take them.
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 windowsills.
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.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
Tell your pharmacist or doctor as soon as possible if you do not feel well while you
are taking Prodeine.
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 contains
Do not take this medicine if you are allergic to any of these ingredients.
What Prodeine looks like
Prodeine is available as white capsule shaped tablets plain on one side and a break
line on the other (Aust R 200605).
Prodeine is available in packs of 24 and 40* tablets.
*pack size currently not marketed
Who distributes Prodeine
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Toll Free Number (medical information): 1800 818 806
Email:
[email protected]
This leaflet was prepared in December 2021.
prodeine-ccdsv5-cmiv12-03dec21