Consumer medicine information

Codapane Forte 500/30

Codeine phosphate hemihydrate; Paracetamol

BRAND INFORMATION

Brand name

Codapane Forte Tablets

Active ingredient

Codeine phosphate hemihydrate; Paracetamol

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Codapane Forte 500/30.

What is in this leaflet

This leaflet answers some common questions about Codapane Forte.

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 Codapane Forte against the benefits this medicine is expected to 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.

What Codapane Forte is used for

Codapane Forte is used to relieve moderate to severe pain, and fever.

Codapane Forte contains paracetamol and codeine. These ingredients work together to stop the pain messages from reaching the brain.

Paracetamol also acts in the brain to reduce fever.

Ask your doctor if you have any questions about why Codapane Forte has been prescribed for you.

Your doctor may have prescribed Codapane Forte for another reason.

This medicine may be addictive after repeated administration.

Codapane Forte is not recommended for children under 12 years of age.

This medicine is available only with a doctor's prescription.

Before you take Codapane Forte

When you must not take it

Do not take Codapane Forte if you have an allergy to:

  • any medicine containing paracetamol or codeine
  • any of the ingredients listed at the end of this leaflet
  • any other similar medicines, such as morphine and oxycodone.
  • Aspirin or any other NSAID medicine.

Some of the symptoms of an allergic reaction may include:

  • 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.

Do not take Codapane Forte if you:

  • breathing difficulties, such as asthma, bronchitis or emphysema
  • Glucose-6-phosphate dehydrogenase deficiency (an enzyme deficiency)
  • Ultra-rapid metaboliser of CYP2D6
  • diarrhoea caused by poisoning or antibiotic therapy
  • history of intolerance to paracetamol and/or codeine
  • Liver failure
  • Alcohol dependence.

Do not take Codapane Forte if you are aged between 12 to 18 years of age and have had your tonsils or adenoids removed to treat sleep apnoea.

Do not take Codapane Forte during the third trimester of pregnancy.

Do not take Codapane Forte during labour especially if the baby is premature.

This medicine contains codeine, which may produce withdrawal effects in the newborn baby.

Do not take Codapane Forte if you are breastfeeding or planning to breastfeed.

This medicine passes into breast milk and may affect the baby. If you require Codapane Forte therapy, breastfeeding should be stopped and alternative arrangements should be made for feeding the baby during treatment period.

Do not take Codapane Forte after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Codapane Forte is not recommended for children under 12 years.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

  • lung disease, such as asthma, bronchitis or emphysema
  • liver disease, hepatitis, or are taking other drugs that may affect the liver
  • kidney disease or difficulty urinating
  • irritable bowel syndrome or other bowel problems
  • diarrhoea caused by poisoning
  • recent gastrointestinal or urinary tract surgery
  • prostate problems
  • history of fits, convulsions or seizures
  • depression
  • a history of drug dependence, including alcohol dependence
  • you drink large quantities of alcohol
  • recent cessation of alcohol
  • low glutathione reserves
  • Gilbert's syndrome
  • Gall bladder problems or your gall bladder has been removed
  • Multiple sclerosis
  • an underactive thyroid gland or adrenal glands not working properly (e.g. Addison's disease)
  • head injury or brain tumour
  • if you are under 18 and have undergone adenoidectomy and/or tonsillectomy
  • if you know you are a CYP 2D6 ultra-rapid metaboliser.

Your doctor may want to take special care if you have any of these conditions.

Tell your doctor if you are pregnant or plan to become pregnant.

Your doctor can discuss with you the risks and benefits of taking Codapane Forte while being pregnant.

Tell your doctor if you plan to have surgery that requires a general anaesthetic.

Codapane Forte may affect other medicines used during surgery.

If you have not told your doctor about any of the above, tell him/ her before you start taking Codapane Forte.

Taking other medicines

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

Some medicines and Codapane Forte may interfere with each other. These include:

  • any medicine causing sleepiness or drowsiness
  • tranquillisers (medications for anxiety and nerves)
  • benzodiazepines (medicines used as sedatives or to treat anxiety)
  • medicines containing alcohol (ethanol), e.g. some cough syrups
  • cough suppressants or antitussives
  • Medicines used to treat alcohol and/or opioid dependence (e.g. naltrexone or buprenorphine)
  • 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 anti-inflammatory drugs (NSAIDS), such as aspirin or ibuprofen
  • other pain relievers
  • diflunisal, an anti-inflammatory medicine
  • anticholinergics (medicines used to relieve stomach cramps or spasms, to prevent travel sickness, or to treat Parkinson's disease)
  • medicines which thin the blood, such as warfarin
  • medicines used to relax muscles
  • medicines to treat epilepsy
  • chloramphenicol, a medicine used to treat ear and eye infections
  • flucloxacillin, rifampicin or zidovudine, medicines used to treat infections
  • medicines used to lower high blood pressure
  • medicines used to treat diarrhoea, including kaolin, pectin and loperamide
  • metoclopramide, a medicine used to treat nausea and vomiting
  • colestyramine, a medicine used to treat high blood cholesterol, and/or other conditions
  • chelating resin.

These medicines may be affected by Codapane Forte or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist may have more information on medicines to be careful with or avoid while taking Codapane Forte.

How to take Codapane Forte

Always follow the directions given to you by your doctor or pharmacist.

These directions may differ from the information contained in this leaflet.

If you do not understand the directions on the box, ask your doctor or pharmacist for help.

How much to take

Adults:

The usual dose of Codapane Forte is 1 to 2 tablets.

This dosage may be repeated every 4 to 6 hours if needed.

Do not take more than 8 tablets in 24 hours.

If Codapane Forte is not adequately relieving your pain, do not increase the dose. Please see your doctor.

Codapane Forte is not recommended for children under 12 years.

How to take it

Swallow Codapane Forte with a glass of water.

If you forget to take it

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

Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.

Do not take a double dose to make up for the dose that 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 take too much (Overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much Codapane Forte. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

If you take too much Codapane Forte, you may have stomach pain and feel nauseous, sweaty, light headed, dizzy or drowsy, or have difficulty breathing.

While you are taking Codapane Forte

Things you must do

Tell all of the doctors, dentists, and pharmacists who are treating you that you are taking Codapane Forte.

If you are about to start taking any new medicine tell your doctor and pharmacist that you are taking Codapane Forte.

Tell your doctor if you become pregnant while taking Codapane Forte.

If you are about to have any blood test, tell your doctor that you are taking this medicine.

It may interfere with the results of some tests.

Things you must not do

Do not give Codapane Forte to anyone else, even if they have the same condition as you.

Do not use Codapane Forte to treat any other complaints unless your doctor tells you to.

Do not take alcoholic drinks.

Combining Codapane Forte and alcohol can make you drowsier.

Things to be careful of

Depending on your body's individual ability to break down codeine, you may experience signs of overdose even when you take Codapane Forte as recommended by your doctor. If symptoms such as blurred vision, dizziness, sleepiness, abdominal pain, or circulatory problems occur, contact your doctor immediately.

Codapane Forte may cause dizziness or drowsiness in some people, especially after the first dose.

If you are affected, do not drive a car, operate machinery or do anything else that could be dangerous if you are dizzy or drowsy.

Children should not ride bikes if affected and should be supervised to avoid potential harm.

Do not drink alcohol.

Drinking alcohol increases the likelihood of becoming drowsy.

Codapane Forte may be addictive if taken in high doses for extended periods of time.

Ask your doctor or pharmacist if you are concerned about this.

Side effects

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

Like other medicines, Codapane Forte can cause some side effects. If they occur, most are likely to be minor and temporary. However, some may be serious and need medical attention.

If you are over 65 years of age you may have an increased chance of getting side effects.

Do not be alarmed by the following list of side effects. You may not experience any of them.

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

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

  • constipation
  • nausea (feeling sick)
  • vomiting
  • Stomach pain
  • dizziness, light-headedness
  • drowsiness
  • skin rashes
  • sweating.

These are the more common side effects of Codapane Forte. They are usually mild.

Tell your doctor as soon as possible if you notice any of the following:

  • Shortness of breath
  • fever, sore throat or mouth ulcers
  • bleeding or bruising more easily than normal
  • 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).
  • difficulty passing urine

The above list includes serious side effects that may require medical attention. These side effects are rare.

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

  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.

Some people may get other side effects that are not listed above.

If you are taking Codapane Forte regularly, you may also need to take laxatives to prevent constipation.

Tell your doctor or pharmacist if you notice anything else that is making you feel unwell.

After taking Codapane Forte

Storage

Keep your tablets in the pack until it is time to take them.

If you take the tablets out of the box and blister pack they will not keep well.

Keep Codapane Forte tablets in a cool dry place where the temperature stays below 25°C.

Do not store Codapane Forte or any other medicine in the bathroom or near a sink. Do not leave it in the car or on window sills.

Heat and dampness 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 tells you to stop taking Codapane Forte or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.

Product description

What it looks like

Codapane Forte tablets are white, oblong, convex tablets with "PC/F" ("PC" over breakline over "F") on one side and "α" on the other.

They are available in packs of 20s.

Ingredients

The active ingredients in Codapane Forte tablets are paracetamol (present as "Compap L") and codeine phosphate hemihydrate. Each tablet contains 500 mg paracetamol and 30 mg codeine phosphate hemihydrate.

The tablets also contain the following inactive ingredients:

  • crospovidone
  • colloidal anhydrous silica
  • sodium lauryl sulfate
  • stearic acid
  • magnesium stearate

Codapane Forte tablets contain maize starch.

They do not contain lactose or sugar.

Supplier

Codapane Forte is supplied in Australia by:

Alphapharm Pty Limited
(ABN 93 002 359 739)
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000

www.mylan.com.au

Australian registration number:
AUST R 99732

This leaflet was prepared on 10 August 2017

Codapane forte_cmi\Jul17/00

BRAND INFORMATION

Brand name

Codapane Forte Tablets

Active ingredient

Codeine phosphate hemihydrate; Paracetamol

Schedule

S4

 

1 Name of Medicine

Paracetamol and codeine phosphate hemihydrate.

2 Qualitative and Quantitative Composition

Each capsule-shaped tablet contains paracetamol 500 mg, codeine phosphate hemihydrate 30 mg.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Codapane Forte 500/30 is available as capsule-shaped tablets.
The capsule-shaped tablets are white to off-white, marked "P" and "F" either side of a score line on one side and plain on the other. The dimensions of the capsule-shaped tablet are 17.46 x 7.14 x 6.05 mm.

4 Clinical Particulars

4.1 Therapeutic Indications

Codapane Forte is indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.

4.2 Dose and Method of Administration

Adults and children 12 years of age and over.

1 or 2 tablets every 4 to 6 hours if necessary for relief of severe pain. Do not exceed 8 tablets in a 24-hour period.
Codapane Forte 500/30 is contraindicated for use in patients who are:
younger than 12 years;
aged between 12-18 years in whom respiratory function might be compromised, including post tonsillectomy and/or adenoidectomy for obstructive sleep apnoea. (Also see Section 4.3 Contraindications; Section 4.4 Special Warnings and Precautions for Use, Paediatric use).
Tablets to be taken with water.

4.3 Contraindications

Codapane Forte 500/30 must not be used in patients with known hypersensitivity to paracetamol, codeine or any of the excipients used in this product. It must not be used in patients with known glucose-6-phosphate-dehydrogenase deficiency, severe respiratory disease, acute respiratory disease and respiratory depression, for example acute asthma, acute exacerbations of chronic obstructive pulmonary disease since codeine may exacerbate the condition.
Paracetamol should not be used in patients with a history of intolerance to the drug.
Paracetamol should not be used in patients with severe hepatocellular insufficiency.
Due to codeine's structural similarity to morphine and oxycodone, patients experiencing systemic allergy (generalised rash, shortness of breath) to these drugs should not receive codeine.
Codeine is contraindicated in patients with diarrhoea caused by poisoning, until the toxic substance has been eliminated from the gastrointestinal tract, or diarrhoea associated with pseudomembranous colitis caused by antibiotic administration since codeine may slow the elimination of the toxic material or antibiotic.
Paracetamol should not be used in patients with active alcoholism as chronic excessive alcohol ingestion predisposes patients to paracetamol hepatotoxicity.
Codeine is contraindicated in the event of impending childbirth or in case of risk of premature birth (see Section 4.6 Fertility, Pregnancy and Lactation, Use in pregnancy).
Codapane Forte 500/30 is contraindicated during breast-feeding (see Section 4.6 Fertility, Pregnancy and Lactation, Use in lactation).
Codapane Forte 500/30 is contraindicated for use in patients who are:
younger than 12 years (see Section 4.4 Special Warnings and Precautions for Use, Paediatric use);
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 life-threatening adverse reactions (see Section 4.4 Special Warnings and Precautions for Use, Paediatric use).
Codapane Forte 500/30 is contraindicated for use in patients who are CYP2D6 ultra-rapid metabolisers (see Section 4.4 Special Warnings and Precautions for Use, CYP2D6 metabolism).

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. In view of the increased risk of hepatotoxicity, the benefit should be weighed against the risk when administering Codapane Forte 500/30 to patients with viral hepatitis or pre existing hepatic disease.
In such patients, hepatic function determinations may be required at periodic intervals during high dose or long-term therapy.
To avoid the risk of overdose, check that paracetamol is absent from the composition of other medicinal products taken concomitantly.
Caution is advised in patients with underlying sensitivity to aspirin and/or to non-steroidal anti-inflammatory drugs (NSAIDs).

Severe cutaneous adverse reactions (SCARs).

Life-threatening cutaneous reactions Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) have been reported with the use of paracetamol. Patients should be advised of the signs and symptoms and monitored closely for skin reactions. If symptoms or signs of SJS and TEN (e.g. progressive skin rash often with blisters or mucosal lesions) occur, patients should stop paracetamol treatment immediately and seek medical advice.
Paracetamol should be used with caution in patients with:
recent cessation of alcohol intake;
low glutathione reserves;
Gilbert's syndrome.
Codeine should be used with caution in patients with CNS depression or decreased respiratory reserve e.g. in emphysema, kyphoscoliosis, hypoxia, hypercapnia or even severe obesity or cor pulmonale, or chronic obstructive pulmonary disease.
Codeine may exacerbate respiratory impairment and CNS depression. Codeine should be administered with caution in patients with impaired cardiac, hepatic or renal function, hypotension, benign prostatic hyperplasia, urethral stenosis, chronic colitis ulcerative, gall bladder conditions, multiple sclerosis, hypothyroidism, adrenocortical insufficiency (e.g. Addison's disease), shock, myxedema, acute alcohol intoxication or delirium tremens since codeine may exacerbate the symptoms or increase the risk of respiratory and/or CNS depression.
Codeine should be administered with great caution in patients with head injury, brain tumour or increased intracranial pressure since codeine may increase the risk of respiratory depression and further elevate intracranial pressure. In addition codeine can produce side effects such as confusion, miosis and vomiting which are important signs in following the clinical course of patients with head injuries.
Extensive use of analgesics to relieve headaches or migraines, especially at high doses, may induce headaches that must not be treated with increased doses of the drug. In such cases the analgesic should not continue to be taken without medical advice.
Monitoring after prolonged use should include blood count, liver function and renal function.
Codeine should only be used with careful risk-benefit assessment and great caution in the case of:
Opioid dependence;
Chronic constipation;
Conditions with elevated intracranial pressure and head trauma. Codeine can increase the pressure of cerebrospinal fluid and may increase the respiratory depressant effect. Like other narcotics, it causes adverse reactions that can obscure the clinical course of patients with head injury;
Impaired consciousness;
Compromised respiratory function (due to emphysema, kyphoscoliosis, severe obesity) and chronic obstructive airway disease.
Patients with known analgesic intolerance or known bronchial asthma must only use Codapane Forte 500/30 after having consulted a physician (hypersensitivity reactions including bronchospasm possible).
Codeine should be administered with caution in patients with acute abdominal conditions since codeine may obscure the diagnosis or the course of the disease. Codeine should be administered with caution in patients with severe inflammatory bowel disease (risk of toxic megacolon may be increased, especially with repeated dosing). Codapane Forte 500/30 should also be used with caution in patients who have had recent gastrointestinal tract surgery.
Patients who have had a cholecystectomy should be treated with caution. The contraction of the sphincter of Oddi can cause symptoms resembling those of myocardial infarction or intensify the symptoms in patients with pancreatitis.
Codeine should be administered with caution in patients with a history of convulsive disorders (convulsions may be induced or exacerbated by codeine).
Codeine should be administered with caution in patients with prostatic hypertrophy, urethral structure or recent urinary tract surgery since codeine may cause urinary retention.
Codeine should be used with caution in elderly or debilitated patients because of the danger of respiratory or cardiac depression.
Codeine should be administered with caution in patients taking Monoamine Oxidase Inhibitors (MAOIs) (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

Hazardous and harmful use.

Codapane Forte contains the opioid codeine and is a potential drug of abuse, misuse and addiction. Addiction can occur in patients appropriately prescribed Codapane Forte at recommended doses.
The risk of addiction is increased in patients with a personal or family history of substance abuse (including alcohol and prescription and illicit drugs) or mental illness. The risk also increases the longer the drug is used and with higher doses. Patients should be assessed for their risks for opioid abuse or addiction prior to being prescribed Codapane Forte.
There have been reports of drug abuse with codeine, including cases in children and adolescents. Caution is particularly recommended for use in children, adolescents, young adults and in patients with a history of drug and/or alcohol abuse (see Section 4.4 Special Warnings and Precautions for Use, Paediatric use).
All patients receiving opioids should be routinely monitored for signs of misuse and abuse. Opioids are sought by people with addiction and may be subject to diversion. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the safe storage and proper disposal of any unused drug (see Section 6.4 Special Precautions for Storage; Section 6.6 Special Precautions for Disposal). Caution patients that abuse of oral or transdermal forms of opioids by parenteral administration can result in serious adverse events, which may be fatal.
Patients should be advised not to share Codapane Forte with anyone else.

Respiratory depression.

Serious, life-threatening or fatal respiratory depression can occur with the use of opioids even when used as recommended. It can occur at any time during the use of Codapane Forte but the risk is greatest during initiation of therapy or following an increase in dose. Patients should be monitored closely for respiratory depression at these times.
The risk of life-threatening respiratory depression is also higher in elderly, frail, or debilitated patients, in patients with hepatic and renal impairment (see Use in hepatic impairment and Use in renal impairment) and in patients with existing impairment of respiratory function (e.g. chronic obstructive pulmonary disease; asthma). Opioids should be used with caution and with close monitoring in these patients. The use of opioids is contraindicated in patients with severe respiratory disease, acute respiratory disease and respiratory depression (see Section 4.3 Contraindications).
The risk of respiratory depression is greater with the use of high doses of opioids, especially high potency and modified release formulations, and in opioid naïve patients. Initiation of opioid treatment should be at the lower end of the dosage recommendations with careful titration of doses to achieve effective pain relief. Careful calculation of equianalgesic doses is required when changing opioids or switching from immediate release to modified release formulations, together with consideration of pharmacological differences between opioids.
Consider starting the new opioid at a reduced dose to account for individual variation in response.

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

Concomitant use of opioids and benzodiazepines or other CNS depressants, including alcohol, may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing of Codapane Forte with CNS depressant medicines, such as other opioid analgesics, benzodiazepines, gabapentinoids, cannabis, sedatives, hypnotics, tricyclic antidepressants, antipsychotics, antihistamines, centrally-active anti-emetics and other CNS depressants, should be reserved for patients for whom other treatment options are not possible. If a decision is made to prescribe Codapane Forte concomitantly with any of the medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible. Patients should be followed closely for signs and symptoms of respiratory depression and sedation. Patients and their caregivers should be made aware of these symptoms. Patients and their caregivers should also be informed of the potential harms of consuming alcohol while taking Codapane Forte.

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

Opioid analgesics have an established role in the treatment of acute pain, cancer pain and palliative and end-of-life care. Current evidence does not generally support opioid analgesics in improving pain and function for most patients with chronic non-cancer pain. The development of tolerance and physical dependence and risks of adverse effects, including hazardous and harmful use, increase with the length of time a patient takes an opioid. The use of opioids for long-term treatment of CNCP is not recommended.
The use of an opioid to treat CNCP should only be considered after maximised non-pharmacological and non-opioid treatments have been tried and found ineffective, not tolerated or otherwise inadequate to provide sufficient management of pain. Opioids should only be prescribed as a component of comprehensive multidisciplinary and multimodal pain management.
Opioid therapy for CNCP should be initiated as a trial in accordance with clinical guidelines and after a comprehensive biopsychosocial assessment has established a cause for the pain and the appropriateness of opioid therapy for the patient (see Hazardous and harmful use, above). The expected outcome of therapy (pain reduction rather than complete abolition of pain, improved function and quality of life) should be discussed with the patient before commencing opioid treatment, with agreement to discontinue treatment if these objectives are not met.
Owing to the varied response to opioids between individuals, it is recommended that all patients be started at the lowest appropriate dose and titrated to achieve an adequate level of analgesia and functional improvement with minimum adverse reactions. Immediate-release products should not be used to treat chronic pain, but may be used for a short period in opioid-naïve patients to develop a level of tolerance before switching to a modified-release formulation. Careful and regular assessment and monitoring is required to establish the clinical need for ongoing treatment. Discontinue opioid therapy if there is no improvement of pain and/or function during the trial period or if there is any evidence of misuse or abuse. Treatment should only continue if the trial has demonstrated that the pain is opioid responsive and there has been functional improvement. The patient's condition should be reviewed regularly and the dose tapered off slowly if opioid treatment is no longer appropriate (see Ceasing opioids).

Tolerance, dependence and withdrawal.

Neuroadaptation of the opioid receptors to repeated administration of opioids can produce tolerance and physical dependence. Tolerance is the need for increasing doses to maintain analgesia. Tolerance may occur to both the desired and undesired effects of the opioid.
Physical dependence, which can occur after several days to weeks of continued opioid usage, results in withdrawal symptoms if the opioid is ceased abruptly or the dose is significantly reduced. Withdrawal symptoms can also occur following the administration of an opioid antagonist (e.g. naloxone) or partial agonist (e.g. buprenorphine). Withdrawal can result in some or all of the following symptoms: dysphoria, restlessness/agitation, lacrimation, rhinorrhoea, yawning, sweating, chills, myalgia, mydriasis, irritability, anxiety, increasing pain, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhoea, increased blood pressure, increased respiratory rate and increased heart rate.
When discontinuing Codapane Forte in a person who may be physically-dependent, the drug should not be ceased abruptly but withdrawn by tapering the dose gradually (see Ceasing opioids; see Section 4.2 Dose and Method of Administration).

Accidental ingestion/exposure.

Accidental ingestion or exposure of Codapane Forte, especially by children, can result in a fatal overdose of codeine. Patients and their caregivers should be given information on safe storage and disposal of unused Codapane Forte (see Section 6.4 Special Precautions for Storage; Section 6.6 Special Precautions for Disposal).

Hyperalgesia.

Hyperalgesia may occur with the use of opioids, particularly at high doses. Hyperalgesia may manifest as an unexplained increase in pain, increased levels of pain with increasing opioid dosages or diffuse sensitivity not associated with the original pain. Hyperalgesia should not be confused with tolerance (see Tolerance, dependence and withdrawal). If opioid induced hyperalgesia is suspected, the dose should be reduced and tapered off if possible. A change to a different opioid may be required.

Ceasing opioids.

Abrupt discontinuation or rapid decreasing of the dose in a person physically dependent on an opioid may result in serious withdrawal symptoms and uncontrolled pain (see Tolerance, dependence and withdrawal). Such symptoms may lead the patient to seek other sources of licit or illicit opioids. Opioids should not be ceased abruptly in a patient who is physically dependent but withdrawn by tapering the dose slowly. Factors to take into account when deciding how to discontinue or decrease therapy include the dose and duration of the opioid the patient has been taking, the type of pain being treated and the physical and psychological attributes of the patient. A multimodal approach to pain management should be in place before initiating an opioid analgesic taper. During tapering, patients require regular review and support to manage any increase in pain, psychological distress and withdrawal symptoms.
There are no standard tapering schedules suitable for all patients and an individualised plan is necessary. In general, tapering should involve a dose reduction of no more than 10 percent to 25 percent every 2 to 4 weeks (see Section 4.2 Dose and Method of Administration). If the patient is experiencing increased pain or serious withdrawal symptoms, it may be necessary to go back to the previous dose until stable before proceeding with a more gradual taper.
When ceasing opioids in a patient who has a suspected opioid use disorder, the need for medication assisted treatment and/or referral to a specialist should be considered.

CYP2D6 metabolism.

Codapane Forte 500/30 is contraindicated for use in patients who are CYP2D6 ultra-rapid metabolisers.
Codeine is metabolised by the liver enzyme CYP2D6 into morphine, its active metabolite. If a patient has a deficiency or is completely lacking this enzyme an adequate analgesic effect will not be obtained. However, if the patient is an extensive or ultra-rapid metaboliser there is an increased risk of developing side effects of opioid toxicity even at commonly prescribed doses. These patients convert codeine into morphine rapidly resulting in higher than expected serum morphine levels. General symptoms of opioid toxicity include confusion, somnolence, shallow breathing, small pupils, nausea, vomiting, constipation and lack of appetite. In severe cases this may include symptoms of circulatory and respiratory depression, which may be life-threatening and very rarely fatal. Children are particularly susceptible due to their immature airway anatomy. Deaths have been reported in children with rapid metabolism who were given codeine for analgesia post adenotonsillectomy. Morphine can also be ingested by infants through breast milk, causing risk or respiratory depression to infants of rapid metaboliser mothers who take codeine.
The prevalence of codeine ultra-rapid metabolism by CYP2D6 in children is not known, but is assumed to be similar to that reported in adults. The prevalence of ultra-rapid metabolisers is estimated to be 1% in those of Chinese, Japanese and Hispanic decent, 3% in African Americans and 1%-10% in Caucasians. The highest prevalence (16%-28%) occurs in North African, Ethiopian and Arab populations.
(Also see Section 4.4 Special Warnings and Precautions for Use, Paediatric use; Section 4.6 Fertility, Pregnancy and Lactation, Use in lactation).

Use in hepatic impairment.

Codapane Forte 500/30 should be administered with caution to patients with hepatic dysfunction, viral hepatitis, and to patients taking other drugs, which affect the liver.

Use in renal impairment.

Codapane Forte 500/30 should be administered with caution to patients with renal dysfunction.

Use in the elderly.

Elderly people may be more sensitive to the effects of this medicinal product. The elderly are more likely to have hypertrophy, prostatic obstruction and age-related renal impairment and may be more susceptible to the undesirable effects due to opioid-induced urinary retention and the respiratory effects of opioid analgesics. Dose reduction may be required.

Paediatric use.

Codapane Forte 500/30 is contraindicated for use in children:
younger than 12 years;
aged between 12-18 years in whom respiratory function might be compromised, including post tonsillectomy and/or adenoidectomy for obstructive sleep apnoea. Respiratory depression and death have occurred in some children who received codeine following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolisers of codeine due to a CYP2D6 polymorphism.
(Also see Section 4.4 Special Warnings and Precautions for Use, CYP2D6 metabolism).

Effects on laboratory tests.

Plasma amylase and lipase activity.

Codeine may cause increased biliary tract pressure, thus increasing plasma amylase and/or lipase concentrations.

Gastric emptying studies.

Gastric emptying is delayed by codeine so gastric emptying studies will not be valid.

Uric acid and blood glucose.

Intake of paracetamol may affect the laboratory determination of uric acid by phosphotungstic acid and of blood glucose by glucose oxidase-peroxidase.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Salicylates and NSAIDs.

Prolonged concurrent use of paracetamol and salicylates or non-steroidal anti-inflammatory drugs may increase the risk of adverse renal effects.

Coumarins.

Paracetamol may increase the risk of bleeding in patients taking warfarin and other coumarin derivatives (antivitamin K). Monitoring of coagulation and bleeding complications is required.

Chloramphenicol.

Paracetamol may slow down the excretion of chloramphenicol, entailing the risk of increased toxicity.

Diflunisal.

Diflunisal may increase the plasma concentrations of paracetamol by 50%.

Anticholinergics.

Concomitant use of codeine and anticholinergic agents may increase the risk of severe constipation and/or urinary retention. Drugs, which decrease gastric emptying, may decrease the absorption of paracetamol.

Cholestyramine.

Cholestyramine reduces the absorption of paracetamol if given within one hour of paracetamol administration.

Chelating resin.

Chelating resin can decrease the intestinal absorption of paracetamol and potentially decrease its efficacy if taken simultaneously.

Propantheline.

Decreases gastric emptying which may decrease the absorption of paracetamol.

Rifampicin.

Concomitant use may increase the likelihood of paracetamol toxicity (see Hepatotoxic drugs and liver microsomal enzyme inducers).

Flucloxacillin.

Co-administration of flucloxacillin with paracetamol may lead to metabolic acidosis, particularly in patients presenting risk factors of glutathione depletion, such as sepsis, malnutrition or chronic alcoholism.

Alcohol.

Codeine may potentiate the effects of alcohol and increase the likelihood of paracetamol toxicity (see Hepatotoxic drugs and liver microsomal enzyme inducers). The concomitant use of alcohol and opioids increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect. Concomitant use with alcohol is not recommended (see Section 4.4 Special Warnings and Precautions for Use).

Metoclopramide.

Codeine may antagonise the effects of metoclopramide on gastrointestinal motility. Paracetamol absorption is increased by drugs, which increase gastric emptying.

Domperidone.

The absorption rate of paracetamol may be increased by domperidone.

Opioid analgesics.

Concurrent use of codeine and other opioid agonists is usually inappropriate as additive CNS depression, respiratory depressant and hypotensive effects may occur. Narcotic analgesics may decrease gastric emptying and therefore decrease the absorption of paracetamol. (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.

Concomitant use of codeine with a partial agonist (e.g. buprenorphine) or antagonist (e.g. naltrexone) can precipitate or delay codeine effects.

Tranquillisers, sedatives, hypnotics, general anaesthetics and CNS depressants.

Codeine may potentiate the effects of these drugs. Concomitant use of tranquillisers or sedatives may enhance the potential respiratory depressant effects of codeine (see Section 4.4 Special Warnings and Precautions for Use, Risks from concomitant use of benzodiazepines or other CNS depressants, including alcohol).

Benzodiazepines.

The concomitant use of alcohol and opioids increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect. Limit dosage and duration of concomitant use of benzodiazepines and opioids (see Section 4.4 Special Warnings and Precautions for Use).

Hepatotoxic drugs and liver microsomal enzyme inducers.

The risk of paracetamol toxicity may be increased in patients receiving other potentially hepatotoxic drugs or drugs that induce liver microsomal enzymes, such as antiepileptics (such as phenobarbital, phenytoin, carbamazepine, topiramate), alcohol, barbiturates and rifampicin. The induced metabolism results in an elevated production of the hepatotoxic oxidative metabolite of paracetamol. Hepatotoxicity will occur if this metabolite exceeds the normal glutathione binding capacity.

Zidovudine.

When used concurrently with zidovudine, an increased tendency for neutropenia or hepatotoxicity may develop. Combination of Codapane Forte 500/30 and zidovudine particularly chronic or multiple-dose paracetamol, should be avoided. If chronic paracetamol and zidovudine are to be given concurrently, monitor white blood count and liver function tests, especially in malnourished patients.

Antiperistaltic antidiarrhoeals (including kaolin, pectin, loperamide).

Concurrent use of these agents with codeine may increase the risk of severe constipation and CNS depression.

Monoamine oxidase inhibitors.

Non-selective MAOI's intensify the effects of opioid drugs, which can cause anxiety, confusion and significant respiratory depression and other side effects of unpredictable severity. Severe and sometimes fatal reactions have occurred in patients concurrently administered MAO inhibitors and pethidine. Codeine should not be given to patients taking non-selective MAOI's or within 2 weeks of stopping such treatment.
As it is unknown whether there is an interaction between the selective MAOI's (reversible inhibitors of monoamine oxidase A) and codeine, caution is advised with this drug combination.

Tricyclic antidepressants.

A codeine-induced respiratory depression can be potentiated by tricyclic antidepressants. (See Section 4.4 Special Warnings and Precautions for Use, Risks from concomitant use of benzodiazepines or other CNS depressants, including alcohol).

Antihypertensives.

Hypotensive effects of antihypertensive agents may be potentiated when used concurrently with codeine and lead to orthostatic hypotension.

Neuromuscular blocking agents.

Codeine may enhance the effects of neuromuscular blocking agents resulting in increased respiratory depression.
Patients receiving other narcotic analgesics, antitussives, antihypertensives, antihistamines, antipsychotics, antianxiety agents, gabapentanoids, cannabis and centrally-active anti-emetics or other CNS depressants (including alcohol) concomitantly with Codapane Forte 500/30 may experience additive CNS depression. (See Section 4.4 Special Warnings and Precautions for Use, Risks from concomitant use of benzodiazepines or other CNS depressants, including alcohol).

CYP2D6 inhibitors.

Codeine is metabolized by the liver enzyme CYP2D6 to its active metabolite morphine. Medicines that inhibit CYP2D6 activity may reduce the analgesic effect of codeine. Patients taking codeine and moderate to strong CYP2D6 inhibitors (such as quinidine, fluoxetine, paroxetine, bupropion, cinacalcet, methadone) should be adequately monitored for reduced efficacy and withdrawal signs and symptoms. If necessary, an adjustment of the treatment should be considered.

CYP3A4 inducers.

Medicines that induce CYP3A4 activity may reduce the analgesic effect of codeine. Patients taking codeine and CYP3A4 inducers (such as rifampin) should be adequately monitored for reduced efficacy and withdrawal signs and symptoms. If necessary, an adjustment of the treatment should be considered.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

See Section 5.3 Preclinical Safety Data, Carcinogenicity.
(Category A)
Paracetamol crosses the placenta, however problems in humans have not been documented.
Opioid analgesics cross the placenta. Regular use during pregnancy may cause physical dependence in the foetus, leading to withdrawal symptoms in the neonate. Administration of codeine during labour may cause respiratory depression in the newborn infant. Codeine may cause respiratory depression and withdrawal syndrome in neonates born to mothers who use codeine during the third trimester of pregnancy. As a precautionary measure, use of Codapane Forte 500/30 should be avoided during the third trimester of pregnancy and during labour. Codeine is contraindicated in the event of impending childbirth or in case of risk of premature birth (see Section 4.3 Contraindications). Codapane Forte 500/30 should only be used during pregnancy under medical supervision if the potential benefit justifies the potential risk to the foetus. If administered during pregnancy, morphinomimetic properties of codeine should be taken into account.
Codapane Forte 500/30 is contraindicated during breast-feeding (see Section 4.4 Special Warnings and Precautions for Use, CYP2D6 metabolism) due to risk of respiratory depression in the infant.
Analgesic doses excreted in breast milk are generally low. However, infants of breast feeding mothers taking codeine may have an increased risk of morphine overdose if the mother is an ultra-rapid metaboliser of codeine. Codeine is excreted into human breast milk. Codeine is partially metabolized by cytochrome P450 2D6 (CYP2D6) into morphine, which is excreted into breast milk. If nursing mothers are CYP2D6 ultra-rapid metabolisers, higher levels of morphine may be present in their breast milk. This may result in symptoms of opioid toxicity in both mother and the breast-fed infant. Life-threatening adverse events or neonatal death may occur even at therapeutic doses (see Section 4.4 Special Warnings and Precautions for Use, CYP2D6 metabolism).
Therefore, Codapane Forte 500/30 is contraindicated for use during breastfeeding. However, in circumstances where a breastfeeding mother requires codeine therapy, breastfeeding should be suspended and alternative arrangements should be made for feeding the infant for any period during codeine treatment.
Breast feeding mothers should be told how to recognise signs of high morphine levels in themselves and their babies. For example, in a mother symptoms include extreme sleepiness and trouble caring for the baby. In the baby, symptoms include signs of increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness. Medical advice should be sought immediately.

4.7 Effects on Ability to Drive and Use Machines

Codapane Forte 500/30 may cause drowsiness disturbances of visuomotor coordination and visual acuity and/or dizziness. Due to the preparation's sedative action, impairment of the mental and/or physical abilities required for the performance of potentially hazardous activities may occur. Hence children engaging in bike riding and other hazardous activities should be supervised to avoid potential harm.
Patients treated with this medication should not drive, operate machinery, or drink alcohol whilst taking this medication.

4.8 Adverse Effects (Undesirable Effects)

Reports of adverse reactions are rare. Although the following reactions have been reported when paracetamol and codeine have been administered:

Haematologic.

Less frequent to rare: agranulocytosis, anaemia, thrombocytopenia.

Genitourinary.

Less frequent to rare: renal failure, uraemia, urinary retention or hesitance.

Hypersensitive.

Less frequent to rare: skin rashes and other allergic reactions, histamine release (hypotension, flushing of the face, tachycardia, breathlessness).

Gastrointestinal.

Common: constipation, nausea, vomiting.

Neurological.

Common: drowsiness, dizziness.
Less frequent to rare: euphoria, dysphoria, at higher doses codeine may cause respiratory depression.

Hepatic.

Very rare: pancreatitis.
Paracetamol has also been associated with dyspepsia, sweating, erythema, urticaria, anaphylactic shock, angioneurotic oedema, leukopenia, neutropenia and pancytopenia. Bronchospasms may be triggered in patients having a tendency of analgesic asthma. Toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), acute generalised exanthematous pustulosis, fixed drug eruption and cytolytic hepatitis, which may lead to acute hepatic failure, have also been reported.
Haemolytic anaemia in patients with underlying glucose 6-phosphate-dehydrogenase deficiency has been reported. Kounis syndrome and bronchospasm have also been reported.
Codeine can cause confusional state, dysphoria, seizure, headache, somnolence, sedation, miosis, tinnitus, dry mouth, pruritus, fatigue, hypotension. Visuomotor coordination and visual acuity may be adversely affected in a dose-dependent manner at higher doses or in particular sensitive patients. Long term use also entails the risk of drug dependence.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

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.

Symptoms.

Toxic symptoms include vomiting, abdominal pain, hypotension, sweating, central stimulation with exhilaration and convulsions in children, drowsiness, respiratory depression, cyanosis and coma. 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, 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. The most serious adverse effect of acute overdosage of paracetamol is a dose-dependent, potentially fatal hepatic necrosis. In adults, hepatotoxicity may occur after ingestion of a single dose of 10 to 15 g (30 tablets) of paracetamol; a dose of 25 g (50 tablets) or more is potentially fatal. Symptoms during the first two days of acute poisoning by paracetamol do not reflect the potential seriousness of the intoxication. Major manifestations of liver failure such as jaundice, hypoglycaemia and metabolic acidosis may take at least three days to develop.
In an evaluation of codeine intoxication in children, symptoms seen included: sedation, rash, miosis, vomiting, itching, ataxia and swelling of the skin. Respiratory failure may occur.
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.

Treatment.

Despite lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention.
Consists primarily of management of paracetamol toxicity; naloxone is the treatment of choice for codeine intoxication. In cases of overdosage, methods of reducing the absorption of ingested drug are important. Prompt administration of 50 g activated charcoal and 500 mL iced mannitol 20% by mouth may reduce absorption.
Determinations of the plasma concentration of paracetamol are recommended.
If the history suggests that 15 g paracetamol or more has been ingested, administer one of the following antidotes:

Acetylcysteine 20% i.v.

Administer 20% acetylcysteine immediately without waiting for positive urine test or plasma level results: initial dose 150 mg/kg over 15 minutes, followed by continuous infusion of 50 mg/kg in 500 mL 5% glucose over 4 hours and 100 mg/kg in 1 L 5% glucose over 16 hours; or

Oral methionine.

2.5 g immediately followed by three further doses of 2.5 g at four hourly intervals. For a 3-year-old child, 1 g methionine 4-hourly for four doses has been used.
If more than ten hours have elapsed since the overdosage was taken, the antidote may be ineffective.
In general, treatment for codeine overdose 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; naloxone 400 microgram may be administered SC, IM or IV; IV may be repeated at intervals of 2 to 3 minutes if necessary. Assisted respiration may be required.
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.

Analgesic and antipyretic: there is evidence to suggest that a combination of paracetamol with codeine is superior in analgesic action to either drug administered alone.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

After oral administration, paracetamol is absorbed rapidly and completely from the small intestine; peak plasma levels occur 30 to 120 minutes after administration.
Food intake delays paracetamol absorption. Codeine has about one-sixth of morphine's analgesic activity. It is well absorbed from the gastrointestinal tract and does not interfere with paracetamol absorption.

Distribution.

Paracetamol is uniformly distributed throughout most body fluids; the apparent volume of distribution is 1 to 1.2 L/kg. Paracetamol can cross the placenta and is excreted in milk. Plasma protein binding is negligible at usual therapeutic concentrations but increases with increasing concentrations.

Metabolism.

Paracetamol is metabolised by the hepatic microsomal enzyme system. In adults at therapeutic doses, paracetamol is mainly conjugated with glucuronide (45-55%) or sulfate (20-30%). A minor proportion (less than 20%) is metabolised to catechol derivatives, and mercapturic acid compounds via oxidation. Paracetamol is metabolised differently by infants and children compared to adults, the sulfate conjugate being predominant. Patients who metabolise drugs poorly via CYP2D6 are likely to obtain reduced benefit from codeine due to reduced formation of the active metabolite.
Codeine is metabolised in the liver to morphine and norcodeine.

Excretion.

Paracetamol is excreted in the urine mainly as the glucuronide and sulphate conjugates. Less than 5% is excreted as unchanged paracetamol with 85-90% of the administered dose eliminated in the urine within 24 hours of ingestion. The elimination half-life varies from 1 to 4 hours.
Codeine, morphine and norcodeine are excreted in the urine, partly as conjugates with glucuronic acid. Excretion is almost complete within 24 hours.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

Toxicity studies in animals have shown that high doses of paracetamol cause testicular atrophy and inhibition of spermatogenesis; the relevance of this finding to use in humans is not known.

6 Pharmaceutical Particulars

6.1 List of Excipients

Other ingredients are maize starch, povidone, potassium sorbate, microcrystalline cellulose, stearic acid, magnesium stearate, purified talc, pregelatinised maize starch, and croscarmellose sodium.

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 25°C.

6.5 Nature and Contents of Container

Codapane Forte 500/30 is available in cartons of 2*, 4*, 10*, 20 and 50 capsule-shaped tablets packaged in PVC/aluminium foil blisters.
* Denotes presentations not available in Australia.

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 a white or almost white, crystalline powder. It is sparingly soluble in water, freely soluble in alcohol and very slightly soluble in methylene chloride. It has a melting point between 168°C and 172°C.
Codeine phosphate hemihydrate is a white or almost white, crystalline powder or small, colourless crystals. It is freely soluble in water and slightly soluble or very slightly soluble in ethanol (96 per cent).

Chemical structure.


Paracetamol MW: 151.17.
Codeine phosphate hemihydrate MW: 406.37.

Chemical formula.

Paracetamol: C8H9NO2.
Codeine phosphate hemihydrate: C18H24NO7P,½H2O.

Chemical name.

Paracetamol: N-(4-Hydroxyphenyl)acetamide.
Codeine phosphate hemihydrate: 7,8-Didehydro-4,5α-epoxy- 3-methoxy-17-methylmorphinan- 6α-ol phosphate hemihydrate.

CAS number.

Paracetamol: CAS No. 103-90-2.
Codeine phosphate hemihydrate: CAS No. 41444-62-6.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (Schedule 4).

Summary Table of Changes