Consumer medicine information

APOHealth Paracetamol Plus Codeine 15 Tablets

Codeine phosphate hemihydrate; Paracetamol

BRAND INFORMATION

Brand name

APOHealth Paracetamol Plus Codeine 15 Tablets

Active ingredient

Codeine phosphate hemihydrate; Paracetamol

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using APOHealth Paracetamol Plus Codeine 15 Tablets.

What is in this leaflet

Read this leaflet carefully before taking your medicine.

This leaflet answers some common questions about APOHEALTH Paracetamol PLUS Codeine 15 tablets. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available.

Ask your doctor or pharmacist:

  • if there is anything you do not understand in this leaflet,
  • if you are worried about taking your medicine, or
  • to obtain the most up-to-date information.

You can also download the most up-to-date leaflet from www.apotex.com.au.

All medicines have risks and benefits. Your doctor or pharmacist has weighed the risks of you using this medicine against the benefits they expect it will have for you.

Pharmaceutical companies cannot give you medical advice or an individual diagnosis.

Keep this leaflet with your medicine. You may want to read it again.

What this medicine is used for

The name of your medicine is APOHEALTH Paracetamol PLUS Codeine 15 tablets. It contains the active ingredients paracetamol and codeine.

It is used to relieve moderate to severe pain.

Your doctor or pharmacist may have given you this medicine for another use. If you require further information, ask your doctor or pharmacist.

How it works

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

This medicine may be addictive if taken for more than a few days at a time.

Use in children

This medicine should not be used in children under 12 years.

Before you take this medicine

When you must not take it

Do not take this medicine if:

  • You are hypersensitive to, or have had an allergic reaction to, paracetamol, codeine or any of the ingredients listed at the end of this leaflet.
    Symptoms of an allergic reaction may include: cough, shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin; fainting; or hay fever-like symptoms.
    If you think you are having an allergic reaction, do not take any more of the medicine and contact your doctor immediately or go to the Accident and Emergency department at the nearest hospital.
  • Do not take this medicine if you are breastfeeding.
  • The expiry date (EXP) printed on the pack has passed.
  • The packaging is torn, shows signs of tampering or it does not look quite right.

Before you start to take it

Before you start taking this medicine, tell your doctor or pharmacist if:

  1. You have allergies to:
    - any ingredients listed under at the end of this leaflet
    - any other medicines
    - any other substances, such as foods, preservatives or dyes.
  2. You have or have had any medical conditions, especially the following:
    - lung disease
    - kidney disease
    - liver disease
  3. You drink large quantities of alcohol.
  4. You are currently pregnant or you plan to become pregnant.
  5. You are currently breastfeeding or you plan to breastfeed.
    Do not take this medicine whilst breastfeeding until you and your doctor have discussed the risks and benefits involved.
  6. You are taking or are planning to take any other medicines.
    This includes vitamins and supplements that are available from your pharmacy, supermarket or health food shop.

Some medicines may interact with Paracetamol and Codeine. These include:

  • medicines causing sleepiness
  • tranquillisers (medicines for anxiety and nerves)
  • medicines which thin the blood
  • medicines to treat epilepsy.

If you are taking any of these you may need a different dose or you may need to take different medicines. Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.

Other medicines not listed above may also interact with paracetamol and codeine.

If you have not told your pharmacist or doctor about any of these things, tell him/her before you take this medicine.

How to take this medicine

The label on your pack will tell you how to take your medicine and how often. If you are unsure about the directions ask your doctor or pharmacist.

How much to take and when to take it

The usual dose of this medicine is:
Adults: 2 tablets.

This dosage may be repeated in 4-6 hours if necessary. You should not take more than 8 tablets in a 24 hour period.

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

If the medicine is not adequately controlling your pain, do not increase the dose. Please see your doctor or pharmacist.

This medicine is not recommended for children under 12 years.

How to take it

Swallow tablets whole with a little water or other liquid.

If you forget to take it

If it is almost time to take your next dose, skip the missed dose and take your next dose at the usual time. 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 missed doses.

This may increase the chance of you experiencing side effects.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints to help you remember.

If you take too much (overdose)

If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively, go to the Accident and Emergency department at your nearest hospital.

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

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

While you are taking this medicine

Things you must do

Take this medicine exactly as your pharmacist or doctor has told you to.

Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.

Tell your doctor or pharmacist if you become pregnant while taking this medicine.

Things you must not do

Do not:

  • Give this medicine to anyone else, even if their symptoms seem similar to yours.
  • Take your medicine to treat any other condition unless your doctor or pharmacist tells you to.
  • Stop taking your medicine, or change the dosage, without first checking with your doctor or pharmacist.

Things to be careful of

This medicine may cause dizziness or drowsiness in some people, especially after the first dose.

If 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.

This medicine may be habit forming if taken in high doses for extended periods of time. Please ask your doctor or pharmacist if you are concerned about this.

About 8% of people are poor metabolisers of codeine. This may not work as well if you are one of those people.

Possible side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking this medicine or if you have any questions or concerns.

Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side effects. Sometimes they are serious but most of the time they are not.

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

  • nausea
  • vomiting
  • stomach pain
  • constipation
    If you are taking this medicine regularly, you may also need to take laxatives to prevent constipation.
  • dizziness
  • drowsiness
    Be careful driving or operating machinery until you know how this medicine affects you.
  • skin rashes

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

If you believe this medicine is not working well for you, do not increase the dose. Please see your pharmacist or doctor.

Allergic reactions

If you think you are having an allergic reaction to this medicine, do not take any more of this medicine and tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital.

Symptoms of an allergic reaction may include some or all of the following:

  • cough, shortness of breath, wheezing or difficulty breathing
  • swelling of the face, lips, tongue, throat or other parts of the body
  • rash, itching or hives on the skin
  • fainting
  • hay fever-like symptoms.

Storage and disposal

Storage

Keep your medicine in its original packaging until it is time to take it.

If you take your medicine out of its original packaging it may not keep well.

Keep your medicine in a cool dry place where the temperature will stay below 30°C.

Do not store your medicine, or any other medicine, in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep this medicine where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor or pharmacist tells you to stop taking this medicine or it has passed its expiry date, your pharmacist can dispose of the remaining medicine safely.

This is not all the information that is available on this medicine. If you have any more questions or are not sure about anything, ask your doctor or pharmacist.

Product description

What APOHEALTH Paracetamol PLUS Codeine 15 tablets looks like

White to off white capsule shaped uncoated tablets, plain on one side and breakline on the other side.

Available in packs of 20 and 40 tablets.

* Not all strengths, pack types and/or pack sizes may be available.

Ingredients

Each tablet contains 500 mg of Paracetamol and 15 mg of Codeine as the active ingredient.

It also contains the following inactive ingredients:

  • Starch - Potato
  • Lactose
  • Povidone
  • Docusate sodium
  • Silica - colloidal anhydrous
  • Magnesium stearate.

This medicine is gluten-free, sucrose-free, tartrazine-free and free of other azo dyes.

Australian Registration Numbers

APOHEALTH Paracetamol PLUS Codeine 15 tablets (blister pack): AUST R 229524.

Sponsor

Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113

APOHEALTH is a trademark used under license.

This leaflet was last updated in January 2015.

BRAND INFORMATION

Brand name

APOHealth Paracetamol Plus Codeine 15 Tablets

Active ingredient

Codeine phosphate hemihydrate; Paracetamol

Schedule

S4

 

Name of the medicine

Paracetamol 500 mg and codeine phosphate 15 mg.

Excipients.

Potato starch, lactose, povidone, docusate sodium, anhydrous colloidal silica, magnesium stearate.

Description

Paracetamol.

Molecular formula: C8H9NO2. Relative molecular mass: 151.2. CAS: 103-90-2. Paracetamol is a white or almost white crystalline powder. It is sparingly soluble in water, freely soluble in alcohol, very slightly soluble in methylene chloride. Paracetamol is an analgesic and antipyretic.

Codeine phosphate.

Molecular formula: C18H21NO3, H3PO4,½H2O. MW: 406.4. CAS: 41444-62-6. Codeine phosphate is a white or almost white, crystalline powder or small, colourless crystals. It is freely soluble in water, slightly soluble or very slightly soluble in ethanol (96%). Codeine phosphate is a cough suppressant and an analgesic.

Pharmacology

Paracetamol's analgesic mechanism of action has not been fully elucidated, but may involve blocking impulse generation at the bradykinin sensitive chemoreceptors that evoke pain.
The antipyretic effect of paracetamol rises from its ability to block the action of prostaglandin synthetase and so prevent the synthesis of prostaglandins in response to the pyrogen stimulus in the region of the anterior hypothalamus.
Codeine acts centrally. It produces analgesia by dulling the response to painful stimuli at several loci in the central nervous system. This causes an alteration in the sensation and affective response of pain.
There is evidence to suggest that a combination of paracetamol with codeine is superior in analgesic action to either drug administered alone.

Pharmacokinetics.

Paracetamol.

After oral administration, paracetamol is absorbed rapidly and completely from the small intestine; peak plasma levels occur 30 to 120 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 increasing 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 metabohised 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 one to four hours. Food intake delays paracetamol absorption.

Codeine.

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.
It is metabolised in the liver to morphine and norcodeine which, with codeine, are excreted in the urine, partly as conjugates with glucuronic acid. Excretion is almost complete within 24 hours. Patients who metabolise drugs poorly via CYP2D6 are likely to obtain reduced benefit from codeine due to reduced formation of the active metabolite. This may be the case in about 8% of patients.

Indications

Temporary relief of moderate to severe acute pain associated with strong headaches, migraine headaches, dental surgery or toothache, menstrual pain and sports injuries (e.g. backaches and muscular pain).

Contraindications

Hypersensitivity to paracetamol or codeine or other ingredients (see Description).

Precautions

APOHealth Paracetamol Plus Codeine 15 tablets should be administered with caution to patients with hepatic or renal dysfunction. Codeine should be used with caution in patients with CNS depression or decreased respiratory reserve. Prolonged use of high doses of codeine may produce dependence.
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.
Adults should not drive, operate machinery or drink alcohol while taking this medication.

Use in pregnancy.

(Category A)
Both paracetamol and codeine 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 effects on the foetus having been observed.
Opioid analgesics may cause respiratory depression in the newborn infant. Prolonged high dose use of codeine prior to delivery may produce codeine withdrawal symptoms in the neonate.

Use in lactation.

Paracetamol and codeine both appear in breast milk in low concentrations. Maternal ingestion of paracetamol in recommended doses does not appear to present a risk to breastfed infants. However, codeine may cause respiratory depression in newborn infants.
APOHealth Paracetamol Plus Codeine 15 tablet is therefore not recommended for breastfeeding mothers unless the potential benefits to the patient outweigh the possible risk to the infant.

Interactions

Anticoagulant dosage may require reduction if this medication is prolonged. Paracetamol absorption is increased by drugs which increase gastric emptying, e.g. metoclopramide, and decreased by drugs which decrease gastric emptying, e.g. propantheline, antidepressants with anticholinergic properties and narcotic analgesics.
Paracetamol may increase chloramphenicol concentrations. The likelihood of paracetamol toxicity may be increased by the concomitant use of enzyme inducing agents, such as alcohol or antiepileptic drugs.
It is possible that interactions could occur between drugs that can inhibit CYP2D6 (such as quinidine, phenothiazines and antipsychotic agents) and codeine.
Concurrent administration of sedatives or tranquillizes may enhance the potential respiratory depressant effects of codeine.

Adverse Effects

Paracetamol.

Reports of adverse reactions are rare. Although the following reactions have been reported, a causal relationship to the administration of paracetamol has been neither confirmed nor refuted: dyspepsia, nausea, allergic and hematological reactions.

Codeine.

Nausea and vomiting, constipation, dizziness and drowsiness have been reported at therapeutic doses of codeine. Very rarely, skin rashes may occur in patients hypersensitive to codeine. Prolonged use of large doses of codeine may result in physiological dependence.

Dosage and Administration

Adults and children over 12 years.

2 tablets four times a day if required (maximum 8 tablets in 24 hours).
Not recommended for 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, hypoglycemia and metabolic acidosis, may take at least three days to develop.

Treatment.

In case of over dosage, contact the Poisons Information Centre (131 126).

Presentation

Tablets (white to off white, capsule shaped, uncoated, plain on one side, breakline on reverse): 20's, 40's (blister pack).

Storage

Store below 30°C.

Poison Schedule

S3.