Consumer medicine information

Chemists' Own Pain Captabs

Codeine phosphate hemihydrate; Paracetamol

BRAND INFORMATION

Brand name

Chemists' Own Pain Captab Tablets

Active ingredient

Codeine phosphate hemihydrate; Paracetamol

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Chemists' Own Pain Captabs.

What is in this leaflet

This leaflet answers some common questions about Chemists’ Own Pain Captabs. 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 or pharmacist has weighed the risks of you taking Chemists’ Own Pain Captabs against the benefits this medicine is expected to have for you.

Keep this information with the tablets.

You may need to read it again.

What are Chemists’ Own Pain Captabs

The active ingredients in these medicines are paracetamol and codeine phosphate hemihydrate.

Paracetamol and codeine phosphate hemihydrate belongs to a group of medicines called analgesics.

Analgesics are pain relievers used to treat pain. Codeine phosphate hemihydrate belongs to a group of medicine known as 'opioid analgesics'.

Chemists’ Own Pain Captabs contain no aspirin.

Chemists’ Own Pain Captabs are available as unscored capsule-shaped tablets and are not designed to be split in half.

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

What Chemists’ Own Pain Captabs are used for

Chemists’ Own Pain Captabs are for the temporary relief of strong pain.

They provide effective temporary relief of pain and discomfort associated with:

  • Backache
  • Headache
  • Migraine Headache
  • Muscle Pain
  • Neuralgia
  • Rheumatic Pain
  • Toothache
  • Period Pain
  • Tension Headache
  • Symptoms of Colds and Flu
  • Pain associated with trauma or surgery.

Your doctor or pharmacist may recommend Chemists’ Own Pain Captabs for another reason. If you want more information ask your doctor or pharmacist.

Before you take Chemists’ Own Pain Captabs

When you must not take it

Do not take Chemists’ Own Pain Captabs if:

  1. you have an allergy to:
    - Paracetamol or Codeine Phosphate hemihydrate, or any of the ingredients listed under “Product Description” at the end of this leaflet.
    The Symptoms of an allergic reaction may include a rash, asthma attack or hay fever.
  2. Do not take this medicine if you have any of the following conditions:
    - Acute breathing difficulties such as bronchitis, unstable asthma or emphysema
    - Glucose-6-phosphate-dehydrogenase deficiency (an enzyme deficiency)
    - Ultra-rapid metaboliser of CYP 2D6
    - Liver failure
    - chronic constipation
    - Diarrhoea caused by antibiotics or poisoning
  • Do not take this medicine if you have a history of drug dependence, including alcohol dependence.
  • Do not take this medicine if you have experienced systemic allergy (generalised rash or shortness of breath) to morphine or oxycodone.
  • Do not take this medicine if you have a history of intolerance to paracetamol and/or codeine.
  • Do not take this medicine if you are under 18 years of age and have had your tonsils or adenoids removed to treat sleep apnoea.
  • Do not take this medicine during the third trimester of pregnancy.
  • Do not take this medicine during labour, especially if the baby is premature.
    This medicine contains codeine, which may produce withdrawal effects in the newborn baby.
  • Do not take this medicine if you are breastfeeding planning to breastfeed.
    The medicine passes into breast milk and may affect the baby.
  • Do not use this medicine after the expiry date (EXP) printed on the pack.
    If you take it after the expiry date it may have no effect at all, or worse, have an entirely unexpected effect.
  • Do not use this medicine if the packaging is torn or shows signs of tampering.
  • Do not use this medicine to treat any other complaint unless your doctor says it is safe.
  • Chemists’ own pain captabs is not recommended for children under 12 years.

Before you start to take Chemists’ Own Pain Captabs

Tell your doctor or pharmacist if you have allergies to:

  • Any other medicines
  • Aspirin or any other NSAID medicine
  • Any other substances, such as foods, preservatives or dyes
  • Any ingredients listed under “product Description” at the end of this leaflet
  • Difficulty breathing, wheezing, chronic cough, asthma, or other chronic breathing conditions

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

  • Lung, heart, liver or kidney problems
  • Difficulty breathing, wheezing, chronic cough, asthma, or other chronic breathing conditions
  • A history of drug dependence, including alcohol dependence
  • You drink large quantities of alcohol
  • Recent cessation of alcohol intake
  • Low glutathione reserves
  • Gilbert’s syndrome
  • Gall bladder problems or your gall bladder has been removed
  • Multiple sclerosis
  • Recent stomach, intestine or urinary tract surgery
  • Irritable bowel syndrome or other bowel problems
  • Prostate problems
  • Under active thyroid gland or problems with your adrenal glands
  • Head injury
  • Fits or Seizures
  • Brain tumours

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

Your pharmacist or doctor will discuss the benefits and possible risks of taking the medicine during pregnancy.

If you have not told your doctor about any of these things, tell them before you take any Chemists’ own pain captabs.

Taking other medicines

You should also tell your doctor about any other medicines that you have bought without a prescription from either your pharmacy, supermarket or health food shop.

Tell your doctor if you are using any other medicines.

Including any of the following medicines:

  • Any medicine causing sleepiness or drowsiness
  • Tranquillisers (medicines for anxiety and nerves)
  • Benzodiazepines (medicines used as sedatives or to treat anxiety)
  • Medicines used to treat alcohol and/or opioid dependence (eg naltrexone or buprenorphine)
  • Medicines containing alcohol (ethanol), e.g. some cough syrups
  • Cough suppressants or antitussives
  • Antihistamines (medicines used to treat allergies)
  • Medicines used to treat depression
  • Medicines used to treat mental illness
  • Warfarin, a medicine used to prevent blood clots
  • Medicines to treat epilepsy
  • Other pain relief medication
  • Medicines used to treat high blood pressure
  • Medicines used to relax muscles
  • Metoclopramide, a medicine used to control, nausea or vomiting
  • Propantheline, a drug used to treat stomach ulcers
  • Cholestyramine (medicine used to treat bile problems and/or high cholesterol
  • Chelating resin
  • Chloramphenicol (antibiotic used to treat ear and eye infections)
  • Flucloxacillin, zidovudine or rifampicin (medicines used to treat infections)
  • Medicines for diarrhoea, such as Kaolin, pectin and loperamide
  • Medicines used to treat parkinson’s disease.
  • Medicines used to relieve stomach cramps or spasms
  • quinidine, a medicine used to treat abnormal or irregular heartbeat.

These medicines may be affected by Chemists own pain captabs or may affect how well Chemists own pain captabs works.

Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.

How to take Chemists’ Own Pain Captabs

The label on your pack of Chemists’ own pain captabs will tell you how to take your medicine and how often.

If you are unsure about the directions ask your doctor or pharmacist.

Do not take more than the dose your doctor or pharmacist has directed.

The dosage recommended by the doctor may be different to the recommended dosage.

The recommended dose of Chemists’ own pain captabs is:

Adults: 1 tablet for mild to moderate pain. 2 tablets for severe pain.

This dosage may be repeated in 4-6 hours if necessary.

Do not take more than 8 tablets in 24 hours.

Do not take more than the recommended dose.

Taking more than the recommended dose may cause liver damage.

Talk to your doctor about pain control if the medicine is not helping.

If your body cannot metabolise codeine properly, you may be getting reduced benefit from the medicine.

How to take it

Swallow the tablets with water.

The directions given to you by your doctor or pharmacist may be different from the information in this leaflet. If you are unsure what dose to take ask your pharmacist or doctor.

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 have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, or go to a hospital straight away, even if you feel well, because of the risk of delayed, serious liver damage.

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

Keep telephone numbers of these places handy.

If you take too many tablets you may feel nauseous, light headed, dizzy or drowsy.

While you are taking Chemists’ Own Pain Captabs

Things you must do

If you are about to start taking any new medicine tell your doctor and pharmacist that you are taking Chemists’ Own Pain Captabs.

Tell all of the doctors, dentists, and pharmacists that are treating you that you are taking Chemists’ Own Pain Captabs.

Things you must not do

Do not give Chemists’ Own Pain Captabs to anyone else, even if they have the same condition as you.

Do not use Chemists’ Own Pain Captabs to treat any other complaints unless your doctor or pharmacist tells you to.

Things to be careful of

This medication may cause dizziness. If affected, do not drive a vehicle or operate machinery. If you drink alcohol, dizziness or drowsiness could be worse. Be careful driving or operating machinery until you know how Chemists' Own Pain Captabs affect you.

Codeine may be habit forming if taken frequently and over a long period. Please ask your doctor or pharmacist if you are concerned about this.

About 8% of people are poor metabolisers of codeine and Chemists' Own Pain Captabs may not work as well if you are one of those people.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while taking Chemists’ own pain captabs.

Like other medicines, Chemists' Own Pain Captabs can cause some side effects. If they occur, they are most likely minor and temporary. However, sometimes they are serious and need medical treatment.

If you have any questions, ask your doctor or pharmacist.

Tell your doctor if you notice any of these side effects and they worry you.

  • skin rashes
  • dry mouth
  • dizziness
  • drowsiness
  • nausea and vomiting
  • stomach pain
  • constipation
  • Sweating

Tell your doctor as soon as possible if you notice any of these 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)

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 on the skin

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare. If you are taking Chemists’ own pain captabs regularly, you may also need to take laxatives to prevent constipation.

Some people may get other side effects not listed above.

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

After taking Chemists’ Own Pain Captabs

Storage

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

If you take the captabs out of the pack they will not keep well.

Keep the Chemists’ own pain captabs in a cool dry place where the temperature stays below 30°C.

Do not store Chemists’ Own Pain Captabs or any other medicine in the bathroom or near a sink.

Do not leave this medicine in the car on hot days.

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 Chemists’ Own Pain Captabs 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

Chemists’ Own Pain Captabs are yellow, capsule-shaped tablets.

They are available in blister packs of 24 or 40 tablets.

Ingredients

Chemists’ Own Pain Captabs

Each Chemists’ Own Pain Captabs contain the following active ingredients:

  • Paracetamol 500 mg
  • Codeine Phosphate hemihydrate 9.6 mg

The following inactive ingredients are found in Chemists’ Own Pain Captabs:

  • Lactose
  • Glyceryl monostearate – self emulsifying
  • Povidone
  • Stearic acid
  • Sodium starch glycollate
  • Magnesium stearate
  • Crospovidone
  • Pre-gelatinised maize starch
  • Quinoline yellow (104) CI47005
  • Sunset yellow (110) CI15985.

Numbers in brackets are the Australian Food Standard codes.

Chemists’ Own Pain Captabs do contain lactose, but do not contain sucrose or gluten.

Manufacturer

Chemists own
Arrow Pharma Pty Ltd
15-17 Chapel Street
Cremorne VIC 3121

Website: www.chemistsown.com.au

The Australian Registration number for Chemists’ Own Pain Captabs is AUST R 93812.

This leaflet was prepared in November 2017

BRAND INFORMATION

Brand name

Chemists' Own Pain Captab Tablets

Active ingredient

Codeine phosphate hemihydrate; Paracetamol

Schedule

S4

 

Name of the medicine

Paracetamol 500 mg, codeine phosphate hemihydrate 9.6 mg.

Excipients.

Lactose, povidone, stearic acid, sodium starch glycollate, glyceryl monostearate - self emulsifying, magnesium stearate, starch - pregelatinised maize, crospovidone, quinoline yellow CI477005, sunset yellow CI15985.

Description

Paracetamol.

Chemical name: N-(4-hydroxyphenyl) acetamide. Molecular formula: C8H9O2. MW: 151.2. A white odourless crystalline powder.

Codeine phosphate hemihydrate.

Chemical name: (5R,6S)-7, 8-didehydro-4,5-epoxy-3- methoxy-N-methylmorphinan-6-ol dihydrogen orthophospate hemihydrate. Codeine phosphate hemihydrate is a small, colourless, odourless crystal or a white, odourless crystalline powder. Molecular formula: C18H21NO3.H3PO4.½H2O. MW: 406.4.

Inactives.

Lactose, povidone, stearic acid, sodium starch glycollate, glyceryl monostearate - self emulsifying, magnesium stearate, starch - pregelatinised maize, crospovidone, quinoline yellow CI477005, sunset yellow CI15985.

Pharmacology

Pharmacokinetics.

After oral administration, paracetamol is absorbed rapidly and completely from the small intestine; peak plasma levels occur 10 to 60 minutes after administration.
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 increased concentrations.
Paracetamol is metabolised by the hepatic microsomal enzyme system. In adults, at therapeutic doses, paracetamol is mainly conjugated with glucuronide (45% to 55%) or sulfate (20% to 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. Paracetamol is excreted in the urine mainly as the glucuronide and sulfate conjugates. Less than 5% is excreted as unchanged paracetamol with 85% to 90% of the administered dose eliminated in the urine within 24 hours of ingestion. The elimination half-life varies from 1 to 3 hours. Food intake delays paracetamol absorption.
Codeine is well absorbed from the gastrointestinal tract and does not interfere with the paracetamol absorption. Peak plasma codeine concentrations occur at about one hour after ingestion of codeine phosphate hemihydrate.
Codeine is metabolised by O-demethylation and N-demethylation in the liver to morphine and norcodeine, and other metabolites including normorphine and hydrocodone. Morphine is the active metabolite of codeine.
Codeine and its metabolites are excreted almost entirely by the kidney, mainly as conjugates with glucuronic acid. Excretion is almost complete within 24 hours. The plasma half-life is between 3 to 4 hours.
The conversion of codeine to morphine is effected by the cytochrome P450 enzyme CYP2D6 and patients who metabolise drugs poorly via CYP2D6 are likely to obtain reduced benefit from codeine due to reduced formation of the active metabolite.

Actions.

Paracetamol is an effective analgesic and antipyretic. It produces analgesia through the central rather than a peripheral effect on the nervous system. Paracetamol does not have anti-inflammatory properties.
Codeine analgesic effect may be due to its conversion to morphine. It binds to receptors in the central nervous system and to alter processes affecting perception to pain and the emotional response to pain. Codeine has about one-sixth the analgesic activity of morphine.

Clinical Trials

Systematic reviews1,2,3 comparing paracetamol-codeine combinations versus paracetamol alone concluded that in single dose studies addition of codeine to paracetamol produced a comparatively small but statistically significant increase in analgesic effect; however, there was an increased incidence of adverse effects with the combination.

Indications

For the temporary relief of acute moderate pain.

Contraindications

Chemists' Own Pain Captabs should not be given to patients with:
known hypersensitivity to paracetamol, codeine phosphate hemihydrate or other opioid analgesics or any of the excipients used in this product. It must not be used in patients with known glucose-6-phosphate-dehydrogenase deficiency, 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 (generalized rash, shortness of breath) to these drugs should not receive codeine.
with chronic constipation.
pre-existing respiratory depression.
Codeine is contraindicated in the event of impending childbirth or in case of risk of premature birth - during labour when delivery of a premature infant is anticipated as it may produce codeine withdrawal symptoms in the neonate (see Precautions - Use in pregnancy).
active alcoholism (as chronic excessive alcohol ingestion predispose patients to paracetamol hepatotoxicity).
Codeine is contraindicated in patients with diarrhoea due to pseudomembranous colitis or poisoning (until the causative organism or toxin has been eliminated from the gastrointestinal tract - since codeine may slow their elimination).
Contraindicated during breast-feeding (see Precautions - Use in lactation).
Contraindicated for use in patients who are younger than 12 years (see Precautions - Paediatric use).
Contraindicated in use in patients who are 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 Precautions - Paediatric use).
Contraindicated for use in patients who are CYP 2D6 ultra-rapid metabolisers (see Precautions - CYP2D6 metabolism).

Precautions

Administer with caution to patients with hepatic or renal dysfunction, viral hepatitis, and to patients taking other drugs, which affect the liver.
Hepatotoxicity may develop after the ingestion of a single dose of 10 to 15 g (200 to 250 mg/kg) of paracetamol and a dose of more than 25 g is potentially fatal. Patients may be asymptomatic for several days following the ingestion of large doses of paracetamol and laboratory evidence of hepatotoxicity may be delayed up to one week. Non-fatal damage is usually reversible. In view of the increased risk of hepatotoxicity, the benefit should be weighed against the risk when administering this medicine 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 therapy or with prolonged use.
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.
Active alcohol consumption (three or more alcoholic drinks daily) and the use of pain relievers containing paracetamol may increase the risk of liver damage or stomach bleeding.
Products containing codeine should not be given for prolonged periods as they may produce physical and psychological dependence. Codeine phosphate hemihydrate may cause constipation.
This medicine should be used with caution in patients with the following.
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. Prolonged use of high doses of codeine may produce dependence and or addiction; Codeine may exacerbate respiratory impairment and CNS depression.
Impaired hepatic function.
Impaired renal function.
Conditions associated with decreased respiratory reserve e.g. asthma or chronic obstructive pulmonary disease (COPD).
Chemists' Own Pain Captabs are contraindicated in conditions associated with pre-existing respiratory depression.
Raised intracranial pressure or head injury.
Prostatic hypertrophy.
Recent cessation of alcohol intake.
Low glutathione reserves.
Gilbert’s syndrome.
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.
Tolerance may also result following repeated administration. Codeine has a primary potential for dependence. Tolerance, psychological and physical dependence develop with prolonged use of high doses with withdrawal symptoms after sudden discontinuation of the drug. Cross-tolerance with other opioids exists. Rapid relapses can be expected in patients with pre-existing opiate dependence (including those in remission).
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 case of:
Opioid dependence.
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.
This medicine 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.
Paracetamol should not be used in patients with a history of intolerance to the drug. Chemists' Own Pain Captabs are contraindicated for use in patients with pre-existing respiratory depression (see Contraindications). Patients with known analgesic intolerance or known bronchial asthma must only use this medicine 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). This medicine 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 or recent urinary tract surgery since codeine may cause urinary retention.
Codeine should be administered with caution in patients taking Monoamine Oxidase Inhibitors (MAOIs) - see Interactions with Other Medicines.

Risks from concomitant use of opioids and benzodiazepines.

Concomitant use of opioids, including codeine, with benzodiazepines may result in sedation, respiratory depression, coma and death. Because of these risks, reserve concomitant prescribing of opioids and benzodiazepines for use in patients for whom alternative treatment options are inadequate.
If a decision is made to prescribe codeine concomitantly with benzodiazepines, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of sedation and respiratory depression (see Interactions with Other Medicines).
Patients should be advised to first consult their healthcare professional before taking codeine if they are taking a benzodiazepine (see Interactions with Other Medicines).

Risks from concomitant use of opioids and alcohol.

Concomitant Use of Opioids, including codeine, with alcohol may result in sedation, respiratory depression, coma and death. Concomitant use with alcohol is not recommended (see Interactions with Other Medicines).
It should also be used with caution in patients who:
have a history of drug abuse;
who are taking other respiratory depressants or sedatives, including alcohol;
have had recent gastrointestinal tract surgery.
This medicine should be used
with caution or in reduced doses in patients with hypothyroidism, adrenocortical insufficiency, prostatic hyperplasia, hypotension, shock, inflammatory or obstructive bowel disorders or myasthenia gravis;
in reduced dosage in elderly or debilitated patients.
Codeine may obscure the diagnosis or the course of gastrointestinal diseases.
Codeine may cause drowsiness. Those affected should not drive or operate machinery.
See Interactions with Other Medicines for additional information.

Use in pregnancy.

(Category A)
Paracetamol crosses the placenta. 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 pregnancy. As a precautionary measure, use of this medicine should be avoided during pregnancy and during labour. Codeine is contraindicated in the event of impending childbirth or in case of risk of premature birth (see Contraindications). This medicine 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.
Australian categorisation definition: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effect on the foetus having been observed.

Use in lactation.

Paracetamol and codeine are excreted into breast milk.
Chemists' Own Pain Captabs is contraindicated during breast-feeding (see Precautions - 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 metabolizer 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 Precautions - CYP2D6 metabolism).
Therefore, Chemists' Own Pain Captabs are 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 recognize 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.

Paediatric use.

Chemists' Own Pain Captabs are 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.
(See also Precautions - CYP2D6 metabolism.)

Use in the elderly.

The elderly are more likely to have age related renal impairment and may be more susceptible to the effects of this medicinal product, particularly to the effects of codeine, due to opioid-induced urinary retention and respiratory depressant effects of codeine.
Codeine should be used with caution in elderly or debilitated patients because of the danger of respiratory or cardiac depression.
Dose reduction may be required.

Carcinogenicity.

Toxicity studies in animals have shown that high doses of paracetamol cause testicular atrophy and inhibition of spermatogenesis.

Effect 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.

CYP2D6 metabolism.

Chemists' Own Pain Captabs are contraindicated for use in patients who are CYP2D6 ultra-rapid metabolisers.
Codeine is metabolized 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 metabolizer 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.
(See also the sections on Pediatric use and Use in lactation.)

Interactions

Anticoagulant dosage may require reduction if the medication is prolonged.
Paracetamol absorption is decreased by drugs which decrease gastric emptying, e.g. propantheline, antidepressants with anticholinergic properties, narcotic analgesics. The likelihood of paracetamol toxicity may be increased in patients by the concomitant use of enzyme inducing agents such as alcohol or anticonvulsant/ antiepileptic drugs.
Paracetamol excretion may be affected and plasma concentrations altered when given with probenecid.
Cholestyramine reduces the absorption of paracetamol if given within 1 hour of paracetamol.
Concurrent administration of other CNS depressants (e.g. hypnotics, sedatives, barbiturates, chloral hydrate and tranquillisers, opioid analgesic, neuroleptics, centrally acting muscle relaxants, anxiolytics and tricyclic antidepressants) can cause additive CNS depression.

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, Increasing chloramphenicol concentrations and entailing the risk of increased toxicity.

Diflunisal.

Diflunisal may increase the plasma concentrations of paracetamol.

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 below).

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 below). 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 Precautions).

Domperidone.

The absorption rate of paracetamol may be increased by domperidone.

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 tranquilliserrs, hypnotics or sedatives
may enhance the potential respiratory depressant effects of codeine.

Benzodiazepines.

The concomitant use of benzodiazepines 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 Precautions).

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.

Zidovudine.

When used concurrently with zidovudine, an increased tendency for neutropenia or hepatotoxicity may develop. Combination of Chemists’ Own Pain Captabs and zidovudine particularly in cases of chronic or multiple-dose paracetamol product use, 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.

Anticholinergics.

Concurrent use of codeine with anticholinergic agents may increase the risk of severe constipation and/or urinary retention.

Antihypertensives.

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

Antiperistaltic antidiarrhoeals (e.g. kaolin, pectin and loperamide).

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

Metoclopramide.

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

Monoamine oxidase inhibitors (MAOIs).

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. Concurrent administration or use within 14 days of ceasing MAOIs may enhance the potential respiratory depressant effects of codeine.

Opioid analgesics.

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

Tricyclic antidepressants.

A codeine-induced respiratory depression can be potentiated by tricyclic antidepressants.

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 or other CNS depressants (including alcohol) concomitantly may experience additive CNS depression.
Substances that inhibit CYP2D6 such as quinidine, phenothiazines and antipsychotic agents can interfere with the metabolism of codeine to morphine, reducing the analgesic effect of codeine.

Adverse Effects

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 retension 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, respiratory depression.

Hepatic.

Very rare: Pancreatitis.
Paracetamol has 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 generalized exanthematous pustulosis, fixed drug eruption and cytolytic hepatitis, which may lead to acute hepatic failure, have also been reported. Dyspepsia, nausea, allergic and haematological reactions have 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.

Codeine can cause confusional state, dysphoriam, seizure, headache, somnolence, sedation, miosis, tinnitus, dry mouth, pruritus, fatigue. Visuomotor coordination and visual acuity may be adversely affected in a dose-dependent manner at higher doses or in particular sensitive patients. Regular use also entails the risk of drug dependence. Nausea and vomiting, constipation, dizziness and drowsiness have been reported at therapeutic doses. Very rarely skin reactions occur in patients hypersensitive to codeine.
Other side effects include respiratory depression, euphoria, dysphoria, histamine release (hypotension, flushing of the face, tachycardia, breathlessness) and other allergic reactions.

Dosage and Administration

Take with water every four to six hours if necessary.

Adults and children over 12 years.

1 or 2 captabs (maximum 8 captabs in 24 hours). Chemists Own Pain Captabs are contraindicated for use in children under 12 years of age.

Overdosage

Symptoms.

Toxic symptoms include vomiting, abdominal pain, hypotension, sweating, central stimulation with exhilaration and convulsions in children, drowsiness, respiratory depression, cyanosis and coma. 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 paracetamol 10 to 15 g (30 tablets); 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.
Codeine overdose produces central stimulation with exhilaration followed by vomiting, drowsiness, respiratory depression and coma. In children, convulsions may occur.

Treatment.

In case of an overdose or further information, contact the Poisons Information Centre on 131 126.

Presentation

Tablet (small, yellow, capsule shaped): 24’s, 40’s (blister pack, AUST R 93812).

Storage

Store below 30°C.

References

1. de Craen AJM, et al. Analgesic efficacy and safety of paracetamol-codeine combinations versus paracetamol alone: a systematic review. BMJ 1996; 313: 321-5. PubMed.
2. Moore A, et al. Single dose paracetamol (acetaminophen), with and without codeine, for postoperative pain. Available in The Cochrane Database of Systematic Reviews; Issue 4. Chichester: John Wiley; 1998. PubMed.
3. Toms L, Derry S, Moore RA, McQuay HJ. Single dose oral paracetamol (acetaminophen) with codeine for postoperative pain in adults. Cochrane Database of Systematic Reviews 2009, Issue 1. Art. No.: CD001547. DOI:10.1002/14651858.CD001547.pub2.

Poison Schedule

S4.