Prodeine

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

 
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.
 

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.
For more information, see Section 1. Why am I using Prodeine? in the full CMI.

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.
For more information, see Section 2. What should I know before I use Prodeine? in the full CMI.

What if I am taking other medicines?

Some medicines may interfere with Prodeine and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

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
More instructions can be found in Section 4. How do I use Prodeine? in the full CMI.

What should I know while using Prodeine?

Things you should do
Remind any doctor, dentist or pharmacist you visit that you are using Prodeine.
Tell your doctor or pharmacist if you are taking any other medicines that you use to help you relax, anything that contains alcohol (like cough syrup) or other medicines that treat pain.
Things you should not do
Do not take more than the recommended dose unless your doctor tells you to.
Do not give this medicine to children under 12 years of age.
Do not take Prodeine during the third trimester of pregnancy or if you are in labour, especially if the baby is expected to be premature.
Driving or using machines
Prodeine may cause drowsiness in some people. If this happens, do not drive or operate machinery.
Drinking alcohol
Do not drink alcohol while taking Prodeine as it may interfere with the effects of the medicine and may increase the risk of liver side effects.
Looking after your medicine
Store below 30° C.
Store in a cool, dry place away from young children.
For more information, see Section 5. What should I know while using Prodeine? in the full CMI.

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.
Active ingredient(s): paracetamol and codeine phosphate hemihydrate
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:

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.

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 acute breathing difficulties such as bronchitis, unstable asthma or emphysema (serious lung disease).
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 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.

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 and sedatives
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.

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 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.
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.

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.

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.
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

Less serious side effects
What to do
Stomach and urinary related:
constipation
vomiting or nausea
indigestion
difficulty in passing urine
Head and neurology related:
ringing in the ear
dizziness
drowsiness
dry mouth
headache
Allergy related
sweating
Speak to your doctor if you have any of these less serious side effects and they worry you.
These are mild side effects of this medicine and usually short-lived.

Serious side effects

Serious side effects
What to do
Allergy related
wheezing or difficulty breathing, shallow breathing or shortness of breath, swelling of the face, lips, tongue or other parts of the body
flushing of the face
Skin related
painful red areas with blisters and peeling layers of skin which may be accompanied by fever and/or chills
severe blisters and bleeding in the lips, eyes, mouth, nose and genitals
skin rashes
Stomach and liver related
hepatitis (symptoms include loss of appetite, itching, yellowing of the skin and eyes, light coloured bowel motions, dark coloured urine)
severe stomach pain, nausea and vomiting
Neurological and behavioural
unusual or extreme mood swings
dizziness, light-headedness
fast heartbeat
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 Prodeine contains

Active ingredient
(main ingredient)
Paracetamol and codeine phosphate hemihydrate.
Other ingredients
(inactive ingredients)
COMPAP L, sodium starch glycollate, purified talc, magnesium stearate
Do not take this medicine if you are allergic to any of these ingredients.

What Prodeine looks like

Prodeine is available as yellow, capsule-shaped tablets with plain on one side and a break line on the other (Aust R 200605).
Prodeine is available in packs of 24 and 40 tablets.

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 April 2020.
prodeine-ccdsv4-cmiv10-23apr20