SUMMARY CMI

Prodeine^®

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.

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

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.

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

3. 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.

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

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

5. What should I know while using Prodeine?

For more information, see Section 5. What should I know while using Prodeine? in the full CMI.

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.

FULL CMI

Prodeine^®

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:

1. Why am I using Prodeine?
2. What should I know before I use Prodeine?
3. What if I am taking other medicines?
4. How do I use Prodeine?
5. What should I know while using Prodeine?
6. Are there any side effects?
7. Product details

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

Published by MIMS January 2022

1 Name of Medicine

Paracetamol, codeine phosphate hemihydrate.

2 Qualitative and Quantitative Composition

Prodeine contains paracetamol 500 mg and codeine phosphate hemihydrate 9.6 mg.
Prodeine is aspirin-free.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

The caplets are white capsule shaped tablets, plain on one side and a breakline on the other.

4 Clinical Particulars

4.1 Therapeutic Indications

For the relief of acute moderate pain and fever.

4.2 Dose and Method of Administration

Adults and children 12 years of age and older.

4.3 Contraindications

Prodeine is contraindicated in patients:
with known hypersensitivity to paracetamol, codeine or any of the excipients used in this product;
with severe respiratory disease, acute respiratory disease and respiratory depression for example an acute asthma attack;
with glucose-6-phosphate-dehydrogenase deficiency;
with severely impaired liver or renal function;
with diarrhoea caused by pseudomembranous colitis or poisoning (until the causative organism or toxin has been eliminated from the gastrointestinal tract, since codeine may slow down the elimination, thereby prolonging the diarrhoea);
with chronic constipation;
with active alcoholism;
during labour when delivery of a premature infant is anticipated as it may produce codeine withdrawal symptoms in neonate;
during breast-feeding (see Section 4.6 Fertility, Pregnancy and Lactation, Use in lactation);
aged between 12 - 18 years in whom respiratory function might be compromised, including post-tonsillectomy and/or adenoidectomy for obstructive sleep apnoea, due to an increased risk of developing serious and life-threatening adverse reactions (see Section 4.4 Special Warnings and Precautions for Use, Paediatric use);
who are CYP2D6 ultra-rapid metabolisers (see Section 4.4 Special Warnings and Precautions for Use, CYP2D6 metabolism).
Prodeine is contraindicated for use in patients younger than 12 years (see Section 4.4 Special Warnings and Precautions for Use, Paediatric use).

4.4 Special Warnings and Precautions for Use

Hepatotoxicity may occur with paracetamol even at therapeutic doses, after short treatment duration and in patients without pre-existing liver dysfunction. This medication may be dangerous when used in large amounts or for long periods. Hepatotoxicity may develop following a dose of 10 g of paracetamol and hepatic failure is known to occur occasionally with the long term use of paracetamol.

To avoid the risk of overdose.

Severe cutaneous adverse reactions (SCARs).

CYP2D6 metabolism.

Hazardous and harmful use.

Respiratory depression.

Risks from concomitant use of benzodiazepines or other CNS depressants, including alcohol.

Use of opioids in chronic (long-term) non-cancer pain (CNCP).

Tolerance, dependence and withdrawal.

Accidental ingestion/exposure.

Hyperalgesia.

Ceasing opioids.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

Uric acid and blood glucose.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Patients receiving other opioid analgesics, antitussives, antihypertensives, antihistamines, antipsychotics, antianxiety or other CNS depressants eg. gabapentinoids, cannabis, centrally-active anti-emetics, hypnotics, sedatives, tranquillisers, including alcohol, may exhibit an additive CNS depression and increases the risk of sedation, respiratory depression, coma and death (see Section 4.4 Special Warnings and Precautions for Use, Risks from concomitant use of benzodiazepines or other CNS depressants, including alcohol).

Morphinic agonists-antagonists.

CYP2D6 inhibitors.

CYP3A4 inducers.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The codeine in Prodeine may cause drowsiness, disturbances of visuomotor coordination and visual acuity, impairing the mental and or physical ability required for the performance of potentially dangerous tasks, in some people. Those affected should not drive or operate machinery or engage in activities which require them to be alert.

4.8 Adverse Effects (Undesirable Effects)

Reports of adverse reactions with paracetamol are rare. Dyspepsia, nausea, sweating, erythema, urticaria, anaphylactic shock, angioneurotic oedema, difficulty in breathing, skin rashes, drop in blood pressure, allergic and haematological reactions (thrombocytopenia, leukopenia, neutropenia, anaemia, agranulocytosis and pancytopenia) have been reported. A causal relationship to the administration of paracetamol has not been confirmed. Toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), acute generalised exanthematous pustulosis, fixed drug eruption (see Section 4.4 Special Warnings and Precautions for Use) and cytolytic hepatitis, which may lead to acute hepatic failure, have also been reported.
Bronchospasm may be triggered in patients having a tendency of analgesic asthma.
Constipation, dry mouth, nausea and vomiting, dizziness, hypotension and drowsiness may occur in association with codeine. Other side effects are rare, especially at dosage levels provided with Prodeine. These include cough suppression, respiratory depression, confusional state, seizure, headache, somnolence, fatigue, sedation, euphoria, dysphoria, skin rashes, pruritus, histamine release (hypotension, flushing of the face, tachycardia, breathlessness) and other allergic reactions. Long term use also entails the risk of drug dependence.
Tinnitus and miosis have been associated with codeine use. Visuomotor coordination and visual acuity may be adverse affected in a dose-dependent manner at higher doses or in particularly sensitive patients.
Very rarely, skin rashes may occur in patients hypersensitive to codeine. Pancreatitis has been reported very rarely.
Renal failure, uraemia, urinary retention or hesitance have been reported less frequently to rarely when both paracetamol and codeine have been administered.
Haemolytic anaemia, particularly in patients with underlying glucose 6-phosphate-dehydrogenase deficiency has been reported. Kounis syndrome has been reported, as has pyroglutamic acidosis in patients with pre-disposing factors for glutathione depletion. Bronchospasm has also been reported.

Reporting suspected adverse effects.

4.9 Overdose

Elderly persons, small children, patients with liver disorders, chronic alcohol consumption or chronic malnutrition, as well as patients concomitantly treated with enzyme-inducing drugs are at an increased risk of intoxication, including fatal outcome.
It has been reported that paracetamol may produce symptoms of acute toxicity in adults, following the ingestion of more than 15 g. Hepatotoxicity may develop after the ingestion of a single dose of 10 to 15 g (200 to 250 mg/kg) and a dose of more than 25 g is potentially fatal. Nausea, vomiting, anorexia, pallor and abdominal pain generally appear during the first 24 hours of overdosage with paracetamol. Overdosage with paracetamol may cause hepatic cytolysis which can lead to hepatocellular insufficiency, gastrointestinal bleeding, metabolic acidosis, encephalopathy, disseminated intravascular coagulation, coma and death. Increased levels of hepatic transaminases, lactate dehydrogenase and bilirubin with a reduction in prothrombin level can appear 12 to 48 hours after acute overdosage. It can also lead to pancreatitis, acute renal failure and pancytopenia. Patients may be asymptomatic for several days following ingestion of large doses of paracetamol and laboratory evidence of hepatotoxicity may be delayed for up to one week. Non-fatal hepatic damage is usually reversible. The antidote, N-acetylcysteine, should be administered as early as possible.
Despite lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention.
Determinations of the plasma concentration of paracetamol are recommended.
Plasma concentration of paracetamol should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable).
Where paracetamol intoxication is suspected, intravenous administration of SH group donators such as acetylcysteine within the first 10 hours after ingestion is indicated. Although acetylcysteine is most effective if initiated within this period, it can still offer some degree of protection if given as late as 48 hours after ingestion; in this case it is taken for longer.
In an evaluation of codeine intoxication in children, symptoms ranked by decreasing order of frequency included sedation, rash, miosis, vomiting, itching, ataxia and swelling of the skin. Respiratory failure may occur. Blood concentrations of codeine ranged from 1.4 to 5.6 microgram/mL in eight adults whose deaths were attributed primarily to codeine overdosage.
The ingestion of very high doses of codeine can cause initial excitation, anxiety, insomnia followed by drowsiness in certain cases, areflexia progressing to stupor or coma, headache, miosis, alterations in blood pressure, arrhythmias, dry mouth, hypersensitivity reactions, cold clammy skin, bradycardia, tachycardia, convulsions, gastrointestinal disorders, nausea, vomiting and respiratory depression.
Severe intoxication can lead to apnoea, circulatory collapse, cardiac arrest and death.
Relating to codeine component. In general, treatment should be symptomatic: re-establish adequate respiratory exchange by ensuring a clear airway and using mechanical ventilation. When treatment for paracetamol toxicity has been initiated the opioid antagonist naloxone hydrochloride is an antidote to respiratory depression; naloxone 400 microgram may be administered SC, IM or IV.
Further measures will depend on the severity, nature and course of clinical symptoms of intoxication and should follow standard intensive care protocols.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Prodeine also contains Compap L, sodium starch glycollate, purified talc and magnesium stearate.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C.

6.5 Nature and Contents of Container

Prodeine is available as caplets of 12*, 24, 36*, or 40*.
*Not marketed.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Paracetamol is an odourless, crystalline powder or crystals with a bitter taste. Codeine phosphate hemihydrate is an odourless, crystalline powder or small colourless crystals with a bitter taste.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (Schedule 4).

Summary Table of Changes