Prodeine 15 Caplets

Prodeine 15 Caplets is a brand of medicine containing the active ingredients paracetamol - codeine.

Find out more about active ingredients.

Consumer medicine information (CMI) leaflet

Developed by the pharmaceutical company responsible for this medicine in Australia, according to TGA regulations.

Prodeine® 15

Paracetamol and codeine phosphate


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Prodeine 15.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine 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.

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What Prodeine 15 is used for

Prodeine 15 is used to relieve moderate to severe pain.

Prodeine 15 contains paracetamol and codeine. Paracetamol and codeine work together to stop the pain messages from getting through to the brain. Paracetamol also acts in the brain to help reduce fever.

Your doctor, however, may prescribe Prodeine 15 for another purpose.

Ask your doctor or pharmacist if you have any questions about why it has been prescribed for you. This medicine is only available with a doctor's prescription.

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Before you take it

When you must not take it

Do not take Prodeine 15 if you have:

  • unstable asthma or emphysema
  • bronchitis
  • glucose-6-phosphate-dehydrogenase deficiency (an enzyme deficiency)
  • diarrhoea caused by antibiotics or poisoning

Do not take Prodeine 15 if you have alcohol dependence.

Do not take Prodeine 15 during the third trimester of pregnancy.

Do not take it if you are in labour, especially if the baby is premature. Prodeine 15 contains codeine, which may produce withdrawal effects in the newborn baby.

Do not take Prodeine 15 if you are allergic to it or any of the ingredients listed at the end of this leaflet. Some symptoms of an allergic reaction include skin rash, itching, shortness of breath or swelling of the face, lips or tongue, which may cause difficulty in swallowing or breathing.

Do not give Prodeine 15 to children under 7 years. There is no experience with its use in children or adolescents under 7 years old.

Do not take it if you are breastfeeding or planning to breastfeed. Prodeine 15 passes into breast milk and there is a possibility your baby may be affected.

Do not take it after the expiry date (EXP) printed on the pack. If you take it after the expiry date has passed, it may not work as well.

Do not take it if the packaging is damaged or shows signs of tampering.

Before you start to take it

Tell your doctor or pharmacist if you have allergies to:

  • any of the ingredients listed at the end of this leaflet
  • aspirin or any other NSAID medicine
  • any other substances, such as foods, preservatives or dyes.

Tell your doctor or pharmacist if you are pregnant or intend to become pregnant. Your doctor or pharmacist will discuss the risks and benefits of taking it if you are pregnant.

Tell your doctor or pharmacist if you have or have had any medical conditions, especially the following:

  • lung, liver or kidney problems
  • difficulty breathing, wheezing, chronic cough, asthma, or other chronic breathing conditions
  • a history of drug dependence, including alcohol dependence
  • stomach or bowl problems
  • recent stomach, intestines or urinary tract surgery
  • prostate problems
  • problems with your adrenal gland or thyroid
  • head injury
  • fits or seizures

Tell your doctor or pharmacist if you plan to have surgery.

Tell your doctor or pharmacist if you drink large quantities of alcohol.

If you have not told your doctor or about any of the above, tell them before you take Prodeine 15.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food store.

Some medicines may affect how Prodeine 15 works. These include:

  • medicines causing sleepiness or drowsiness
  • tranquillisers (medicines for anxiety and nerves)
  • medicines used to treat depression
  • 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
  • chloramphenicol (medicine used to treat ear and eye infections)
  • zidovudine and rifampicin (medicines used to treat infections)

These medicines may be affected by Prodeine 15, or may affect how well it works. You may need to use different amounts of your medicine, or take different medicines. Your doctor or pharmacist will advise you.

Your doctor or pharmacist has more information on medicines to be careful with or to avoid while taking Prodeine 15.

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How to take it

How much to take

The label on your pack of Prodeine 15 will tell you how to take it and how often.

The standard adult dose for this medicine is 2 tablets, taken every 4 to 6 hours if necessary.

You should not take more than 8 tablets in a 24 hour period. Your doctor may have prescribed a different dose.

Ask your doctor or pharmacist if you are unsure of the correct dose for you. They will tell you exactly how much to take.

Follow the instructions they give you. If you take the wrong dose, Prodeine 15 may not work as well and your problem may not improve.

How to take it

Swallow the tablets whole with a little water or other liquid.

When to take it

If you are not sure when to take it, ask your doctor or pharmacist.

How long to take it

Ask your doctor or pharmacist if you are not sure how long to take the medicine for.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take the next dose when you are meant to.

Do not take a double dose to make up for the dose you have missed.

If there is still a long time to go before your next dose, take it as soon as you remember, and then go back to taking it as you would normally.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering when to take your medicine, ask your pharmacist for hints.

If you take too much (overdose)

Immediately telephone your doctor, or the Poisons Information Centre (telephone Australia 13 11 26 or New Zealand 0800 POISON or 0800 764 766), or go to Accident and Emergency at your nearest hospital, if you think you or anyone else may have taken too much Prodeine 15.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

If you take too much Prodeine 15, you will probably feel nauseous, light-headed, dizzy, or drowsy.

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While you are taking it

Things you must do

Tell all the doctors, dentists and pharmacists who are treating you that you are taking Prodeine 15.

If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking Prodeine 15.

If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking this medicine.

If you become pregnant while you are taking given this medicine, stop taking it and tell your doctor or pharmacist immediately.

Things you must 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.
Children should not take more than 4 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 may cause liver damage.

Codeine may be habit forming.

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 doctor tells you to.

Things to be careful of

Be careful driving or operating machinery until you know how Prodeine 15 affects you. It may cause dizziness or light-headedness in some people, especially after the first dose. Make sure you know how you react to it before you drive a car, operate machinery, or do anything else that could be dangerous if you feel dizzy.
Children should not ride bikes if affected and should be supervised to avoid potential harm.

The effects of alcohol could be made worse while taking Prodeine 15. It is not recommended that you drink alcohol while taking 15. Prodeine 15 may be habit forming if taken in high doses for extended periods of time.

Please ask your doctor or pharmacist if you are concerned about this.

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Side effects

All medicines have some unwanted side effects. Sometimes they are serious, but most of the time they are not. Your doctor or pharmacist has weighed the risks of using this medicine against the benefits they expect it will have for you.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Prodeine 15.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • stomach problems such as nausea, vomiting, stomach pain and/or constipation
  • drowsiness
  • dizziness
  • skin rashes
  • sweating

If you are taking Prodeine 15 regularly, you may also need to take laxatives to prevent constipation.

These are mild side effects of this medicine and usually short-lived.

Tell your doctor or pharmacist immediately if you notice any of the following:

  • shortness of breath
  • mouth ulcers, fever and sore throat
  • bleeding, bruising more easily
  • unusual or extreme mood swings
  • dizziness, light-headedness
  • flushing of the face
  • 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
  • hepatitis (symptoms include loss of appetite, itching, yellowing of the skin and eyes, light coloured bowel motions, dark coloured urine)

These may be serious side effects of Prodeine 15. You may need urgent medical attention. Serious side effects are uncommon.

If any of the following happen, stop taking this medicine and tell your doctor immediately, or go to Accident and Emergency at your nearest hospital:

  • swelling of the face, lips, mouth or throat, which may cause difficultly in swallowing or breathing.
  • hives
  • fainting
  • yellowing of the skin and eyes (jaundice)

These are very serious side effects. If you have them, you may have had a serious allergic reaction to Prodeine 15. You may need urgent medical attention or hospitalisation.

These side effects are very rare.

Tell your doctor or pharmacist if you notice anything else that is making you feel unwell. Other side effects not listed above may occur in some consumers.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

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After taking it

If you have any queries about any aspect of your medicine, or any questions regarding the information in this leaflet, discuss them with your doctor or pharmacist.

Storage

Keep your tablets in the blister pack until it is time to take them. If you take the tablets out of the box or the blister pack they may not keep well.

Keep the medicine in a cool, dry place where the temperature stays below 30°C.

Do not store it or any other medicine in the bathroom, near a sink, or on a windowsill.

Do not leave it in the car. Heat and damp 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.

Disposal

If your doctor or pharmacist tells you to stop taking Prodeine 15, or the medicine has passed its expiry date, ask your pharmacist what to do with any that are left over.

Return any unused medicine to your pharmacist.

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Product description

What it looks like

Prodeine 15 is a white, scored, capsule shaped tablet, marked 'PRO 15.'

Prodeine 15 is available in boxes of 20 or 50 tablets.

Ingredients

Active Ingredient (s):

  • Paracetamol 500 mg
  • Codeine phosphate 15 mg

Inactive Ingredients:

  • maize starch
  • purified talc
  • pregelatinised maize starch
  • povidone
  • stearic acid
  • potassium sorbate
  • magnesium stearate
  • microcrystalline cellulose

Prodeine 15 does not contain gluten, sucrose, lactose, tartrazine or any other azo dyes.

Manufacturer/Sponsor

Prodeine 15 is supplied in Australia by:
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113

This leaflet was prepared in October 2013.

Australian Register Number(s)
AUST R 153884

® Registered Trademark

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CMI provided by MIMS Australia, December 2014  

Latest information - Prodeine 15 Caplets

Audience:
       

For health professionals (Health professional publication)
13 Aug 2013 Deaths and near-fatal cases of respiratory depression (hypoventilation) in children taking codeine for pain relief have prompted new international safety warnings. Find out about the new international guidance, the reasons behind it and what this means for your patients in Australia.
(Condition)
02 Nov 2012 Find reliable, independent information about severe pain. You’ll find resources for consumers and health professionals about this health condition and any related treatments, medicines and medical tests.
(Condition)
02 Nov 2012 Find reliable, independent information about fever. You’ll find resources for consumers and health professionals about this health condition and any related treatments, medicines and medical tests.fever is also known as pyrexia and pyrexia.