Consumer medicine information

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

Published by MIMS March 2018

Name of the medicine

Paracetamol 500 mg, codeine phosphate hemihydrate 9.6 mg.

Excipients.

Description

Paracetamol.

Codeine phosphate hemihydrate.

Inactives.

Pharmacology

Pharmacokinetics.

Actions.

Clinical Trials

Systematic reviews^1,2,3 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.

Risks from concomitant use of opioids and alcohol.

Use in pregnancy.

Use in lactation.

Paediatric use.

Use in the elderly.

Carcinogenicity.

Effect on laboratory tests.

Plasma amylase and lipase activity.

Gastric emptying studies.

CYP2D6 metabolism.

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.

Coumarins.

Chloramphenicol.

Diflunisal.

Chelating resin.

Propantheline.

Rifampicin.

Flucloxacillin.

Alcohol.

Domperidone.

Morphinic agonists/antagonists.

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

Benzodiazepines.

Hepatotoxic drugs and liver microsomal enzyme inducers.

Zidovudine.

Anticholinergics.

Antihypertensives.

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

Metoclopramide.

Monoamine oxidase inhibitors (MAOIs).

Opioid analgesics.

Tricyclic antidepressants.

Neuromuscular blocking agents.

Adverse Effects

The following reactions have been reported when paracetamol and codeine have been administered.

Haematologic.

Genitourinary.

Hypersensitive.

Gastrointestinal.

Neurological.

Hepatic.

Codeine.

Dosage and Administration

Take with water every four to six hours if necessary.

Adults and children over 12 years.

Overdosage

Symptoms.

Treatment.

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.