Consumer medicine information

APOHealth Ibuprofen Plus Codeine Tablets

Codeine phosphate hemihydrate; Ibuprofen

BRAND INFORMATION

Brand name

APOHealth Ibuprofen Plus Codeine Tablets

Active ingredient

Codeine phosphate hemihydrate; Ibuprofen

Schedule

S4

 

Consumer medicine information (CMI) leaflet

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

What is in this leaflet

Read this leaflet carefully before taking your medicine.

This leaflet answers some common questions about APOHEALTH Ibuprofen Plus Codeine 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 Ibuprofen Plus Codeine Tablets. It contains the active ingredients ibuprofen and codeine.

This medicine relieves inflammation and strong pain associated with:

  • migraine headache
  • tension headache
  • headache
  • period pain
  • dental pain
  • back pain
  • neuralgia
  • rheumatic pain
  • arthritic pain
  • muscular pain.

Ask your doctor or pharmacist if you have any questions about why this medicine has been recommended for you.

How it works

Ibuprofen belongs to a family of medicines called non-steroidal anti-inflammatory drugs (NSAIDS). This group of medicines work by relieving pain, inflammation (swelling, redness, soreness) and fever.

Codeine is an opioid analgesic that works in the brain and spinal cord to relieve pain.

There is evidence that using these types of medicines can lead to dependence.

Use in children

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

Before you take this medicine

When you must not take it

Do not take this medicine if:

  • You have or have had any of the following:
    - vomiting blood or material that looks like coffee grounds
    - bleeding from the rectum (back passage), have black sticky bowel motions (stools) or bloody diarrhoea
    - stomach ulcer
    - chronic constipation or shallow breathing, or severe diarrhoea
    - consume heavy amounts of alcohol regularly
  • You are pregnant, unless advised by your doctor.
    NSAIDs should not be taken during pregnancy.
  • You are in the last three months of pregnancy.
  • You are taking medicines that contain one or more NSAIDs, whether prescribed by your doctor or obtained without prescription.
    Several medicines used to treat headache, period pain and other aches and pains contain aspirin or NSAIDs. If you are not sure if the medicines you are taking contain these ingredients, ask your pharmacist.
  • You are hypersensitive to, or have had an allergic reaction to:
    - ibuprofen, aspirin or other NSAID medicines.
    - allergy symptoms may be severe.
    - codeine or other opioid analgesics such as morphine or pethidine.
    - 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.
  • 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.

If you are not sure whether you should start taking this medicine, contact your pharmacist or doctor.

Before you start to take it

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

  1. You have allergies to:
    - any other medicines
    - any other substances, such as foods, preservatives or dyes.
  2. You have or have had any medical conditions, especially the following:
    - a history of stomach ulcer.
    - liver disease.
    - kidney disease.
    - heart failure.
    - swelling of ankles or feet.
    - asthma, or have suffered in the past from asthma.
    - thyroid problems or low blood pressure.
    - a head injury or intercranial pressure.
    - prostate problems.
    - stomach problems or recent stomach surgery.
  3. You are currently pregnant or you plan to become pregnant.
    This medicine is not recommended for use during pregnancy. Your doctor will decide if you should take this medicine.
  4. You are currently breastfeeding or you plan to breastfeed.
    This medicine is not recommended while you are breastfeeding. If there is a need to consider this medicine while you are breastfeeding, your pharmacist or doctor will discuss the benefits and risks involved.
  5. 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.

Taking other medicines

Some medicines may interact with ibuprofen and codeine. These include:

  • aspirin, salicylates or other NSAID medicines.
  • warfarin or other medicines used to stop blood clots or thin the blood.
  • medicines that are used to treat high blood pressure eg diuretics (fluid tablets) or heart problems.
  • methotrexate a medicine used to treat arthritis and some types of cancer.
  • zidovudine a medicine used to treat HIV infection.
  • lithium and other medicines used to treat depression or anxiety eg MAOIs (even if taken within the last 14 days).
  • medicines used to relieve stomach cramps or spasms.
  • medicines used to treat diarrhoea (eg kaolin, pectin, loperamide).
  • metoclopramide, a medicine used to treat nausea and vomiting.
  • medicines such as prednisone, prednisolone and cortisone, which reduce the activity of your immune system.
  • medicines used to help you relax, sleep or relieve anxiety, such as barbiturates and sedatives.
  • quinidine, a medicine used to treat abnormal or irregular heart beat.
  • phenothiazines and antipsychotic agents, medicines used to treat mental disorders.
  • medicines used to treat diabetes.
  • medicines used to treat Parkinson's disease.
  • medicines used to prevent travel sickness.
  • other opioids to treat pain or suppress cough.

If you are taking any of these you may need a different dose or you may need to take different medicines.

Other medicines not listed above may also interact with this medicine.

Your pharmacist and doctor have more information on medicines to avoid or be careful with while taking this medicine.

How to take this medicine

Follow carefully all directions given to you by your doctor or pharmacist. Their instructions may be different to the information in this leaflet.

How much to take

Adults and children over 12 years of age:
2 tablets followed by, if necessary, 1 or 2 tablets every 4 hours.

Do not take more than 6 tablets in 24 hours.

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

How to take it

Take this medicine by mouth with fluid. It may also be taken before, or after food.

How long to take it for

You should not take this medicine for more than a few days.

If your symptoms persist, worsen or new symptoms develop, talk to your doctor/pharmacist.

If you take too much (overdose)

If you take too much of this medicine you may experience nausea or upset stomach, vomiting and gastric irritation, drowsiness, dizziness or very slow, laboured breathing. You may also experience blurred vision, ringing in the ears, or rapid uncontrollable movements of the eyes. Excitability, convulsions and unconsciousness may be experienced in rare cases.

If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor 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.

While you are taking this medicine

Things you must do

Tell your doctor or pharmacist that you are taking this medicine if:

  • you are about to be started on any new medicine
  • you are pregnant or are planning to become pregnant
  • you are breastfeeding or are planning to breastfeed
  • you are going to have surgery or an anaesthetic or are going into hospital.

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

Stop taking this medicine and tell your doctor or pharmacist:

  • if you become pregnant while taking this medicine.

Talk to your doctor or pharmacist if your symptoms do not improve.

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.
  • Take this medicine with any other product containing ibuprofen and or codeine/ other opioid unless your doctor tells you.
  • Take for more than a few days at a time unless your doctor tells you to.

Things to be careful of

  • Be careful when driving or operating machinery until you know how this medicine affects you.
    This medicine may cause dizziness, light-headedness or drowsiness in some people. If this occurs, do not drive or operate machinery. If you drink alcohol, dizziness, light-headedness or drowsiness may be worse.
  • Products containing codeine should not be taken for prolonged periods. Codeine may be habit forming.

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 if you notice any of the following:

  • stomach upset including nausea (feeling sick), vomiting.
  • heartburn, indigestion.
  • diarrhoea, pain in the stomach.
  • dizziness, light-headedness, drowsiness.
  • constipation.
  • cough suppression.
  • headache.
  • hearing disturbance.

These are the more common side effects of this medicine and are usually mild and short lived.

If you experience any of the following, stop taking your medicine and contact your doctor immediately or go to the Accident and Emergency department at your nearest hospital.

These are very serious side effects and you may need urgent medical attention or hospitalisation:

  • vomiting blood or material that looks like coffee grounds.
  • bleeding from the back passage, black sticky bowel motions (stools) or bloody diarrhoea.
  • swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing.
  • asthma, wheezing, shortness of breath, pain or tightness in the chest.
  • sudden or severe itching, skin rash, hives, skin peeling.
  • easy bruising.
  • shallow breathing.
  • fluid retention.

These side effects are rare.

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

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.

Product description

What APOHEALTH Ibuprofen Plus Codeine Tablets looks like

Ibuprofen 200mg and Codeine 12.8mg tablets:
White to off-white capsule-shaped, biconvex, film-coated tablet.
Blister packs of 20 or 30 tablets.

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

Ingredients

Each tablet contains 200mg ibuprofen and 12.8mg codeine phosphate as the active ingredients.

It also contains the following inactive ingredients:

  • Starch - pregelatinised maize
  • Cellulose microcrystalline
  • Croscarmellose sodium
  • Silica colloidal anhydrous
  • Water purified
  • Opadry white colouring

This medicine does not contain gluten or preservatives.

Australian Registration Numbers

APOHEALTH Ibuprofen Plus Codeine Tablets (blister pack): AUST R 227876

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 Ibuprofen Plus Codeine Tablets

Active ingredient

Codeine phosphate hemihydrate; Ibuprofen

Schedule

S4

 

Name of the medicine

Ibuprofen 200 mg, codeine phosphate 12.8 mg.

Excipients.

Microcrystalline cellulose, pregelatinised maize starch, croscarmellose sodium, anhydrous colloidal silica, Opadry complete film coating system OY-58900 white.
APOHealth Ibuprofen Plus Codeine tablets do not contain gluten or preservatives.

Description

Ibuprofen.

Chemical name: 2-(4-isobutylphenyl) propionic acid. Molecular formula: C13H18O2. MW: 206.3. CAS: 15687-27-1. It is a white or almost white powder or crystals with a characteristic odour. Practically insoluble in water, soluble 1 in 1.5 of alcohol, 1 in 1 of chloroform, 1 in 2 of ether and 1 in 1.5 of acetone; soluble in aqueous solutions of alkali hydroxides and carbonates.

Codeine phosphate.

Chemical name: (5R, 6S)-7, 8-didehydro-4,5-epoxy-3-methoxy-N-methylmorphinan-6-ol dihydrogen orthophosphate hemihydrate. Molecular formula: C18H21NO3.H3PO4.½ H2O. MW: 406.4. CAS: 41444-62-6. It is a small, colourless, odourless crystal or a white, odourless crystalline powder. Codeine phosphate is soluble in four parts water, slightly soluble in ethanol (96%), practically insoluble in chloroform and ether.

Pharmacology

Actions.

Ibuprofen possesses analgesic, antipyretic and anti-inflammatory properties, similar to other nonsteroidal anti-inflammatory drugs (NSAIDs). Its mechanism of action is unknown, but is thought to be through peripheral inhibition of cyclooxygenases and subsequent prostaglandin synthetase inhibition.
Codeine acts centrally on opiate receptors. Its analgesic effect is thought to be due mainly to its partial metabolic conversion to morphine. Codeine has about one-sixth the analgesic activity of morphine.

Pharmacokinetics.

Ibuprofen.

Absorption.

It is well absorbed from the gastrointestinal tract after oral administration with peak serum levels occurring after 1-2 hours.

Distribution.

Apparent volume of distribution is 0.14 L/kg. Ibuprofen and its metabolites readily cross the placental barrier in pregnant animals (rabbits and rats). It is not known if ibuprofen enters the cerebrospinal fluid.

Protein binding.

It is highly bound (90-99%) to plasma proteins and consequently, this charateristic of the drug should be considered when prescribing ibuprofen together with other drugs that bind to the same site on human serum albumin.

Metabolism.

90% of ibuprofen is metabolised to inactive compounds in the liver, mainly by glucuronidation, to produce two metabolites, a hydroxylated compound and a carboxylated compound.

Excretion.

Both the inactive metabolites and a small amount of unchanged ibuprofen are excreted rapidly and completely by the kidney, with 95% of the administered dose eliminated in the urine within four hours of ingestion.

Half-life.

The elimination half-life of ibuprofen is in the range of 1.9 to 2.2 hours.

Codeine.

Absorption.

Codeine and its salts are well absorbed from the gastrointestinal tract: peak plasma codeine concentrations occur at about one hour after ingestion of codeine phosphate. Analgesic action occurs in 15 to 30 minutes and analgesia is maintained up to 4-6 hours.

Distribution.

After ingestion codeine is rapidly distributed to skeletal muscles, kidneys, liver, gastrointestinal tract, lungs, spleen and brain. It crosses the placenta and is distributed in low levels in breast milk.

Metabolism.

Codeine is metabolised by O- and N-demethylation in the liver (by CYP2D6 and CYP3A4 respectively) to morphine (about ten percent of a codeine dose is demethylated to morphine), norcodeine and other metabolites including normorphine and hydrocodone. The major metabolic pathway involves glucuronidation of codeine to codeine-6-glucuronide. About 8% of the general Australian population cannot convert codeine to its active metabolite morphine as they are deficient in the CYP2D6 enzyme. These persons are likely to obtain reduced pain relief from codeine.

Excretion.

Codeine and its metabolites are excreted almost entirely by the kidney, mainly as conjugates with glucuronic acid. Of the excreted material in the urine 40-70% is free or conjugated codeine, 5-15% is free or conjugated morphine, and 10-20% is free or conjugated norcodeine. Excretion is almost complete within 24 hours. The plasma half-life of codeine has been reported to be between 2 and 4 hours after oral administration. Only traces of codeine and its metabolites are found in the faeces.

Indications

APOHealth Ibuprofen Plus Codeine is used for temporary relief of strong pain and/or inflammation associated with headache (including migraine and tension headache), period pain, dental pain, back pain, neuralgia, rheumatic and arthritic pain, and muscular pain.

Contraindications

Known hypersensitivity or idiosyncratic reaction to ibuprofen, codeine or other opioid analgesics, or any other ingredients in the product listed in the description section above.
Hypersensitivity to aspirin or other NSAIDs.
Acute respiratory depression.
Active alcoholism.
Active gastrointestinal bleeding or peptic ulceration.
Chronic constipation.
Diarrhoea caused by pseudomembranous colitis or poisoning (until the cause organism or toxin has been eliminated from the gastrointestinal tract, since codeine may slow down the elimination, thereby prolonging the diarrhoea).
Taking other products containing ibuprofen or with other anti-inflammatory medicines (see Interactions with Other Medicines).

Precautions

APOHealth Ibuprofen Plus Codeine should be administered with caution and at lowest effective dose in patients:
with decreased respiratory reserve e.g. asthma or COPD or pre-existing respiratory depression;
with asthma, especially those patients who have not taken an NSAID;
who are taking other respiratory depressants or sedatives, including alcohol;
with hepatic, renal or cardiac impairment;
with hypotension;
with previous history of gastrointestinal haemorrhage or ulcers;
who have had recent gastrointestinal tract surgery;
with hypothyroidism;
with prostatic hypertrophy; codeine may cause urinary retention;
with raised intracranial pressure or head injury;
who are pregnant (see Use in pregnancy and Use in lactation);
who are over the age of 65 (see Use in the elderly);
In patients with renal impairment, renal function should be monitored since it may deteriorate following the use of any NSAID.
As with other drugs of this class, ibuprofen may mask the usual signs of infection. Codeine may also obscure the diagnosis or the course of gastrointestinal diseases.
Physical and/or psychological dependence, including drug tolerance, may occur following prolonged administration of codeine. Codeine may cause drowsiness; those affected should not drive or operate machinery.

Use in pregnancy.

(Category C)
NSAIDs inhibit prostaglandin synthesis and, when given during the latter part of pregnancy, may cause closure of the foetal ductus arteriosus, foetal renal impairment, inhibition of platelet aggregation, and delay labour and birth. Use of ibuprofen is thus contraindicated during the third trimester of pregnancy, including the last few days before expected birth.
Further, there is insufficient experience with the safety of use of ibuprofen in humans during pregnancy. Ibuprofen should therefore not be used during the first 6 months of pregnancy unless the potential benefits to the patient outweigh the possible risk to the foetus.
Based on animal studies and limited clinical experience there is no evidence to suggest foetal abnormalities associated with the use of codeine. However, APOHealth Ibuprofen Plus Codeine tablets should be avoided during pregnancy.

Use in lactation.

Ibuprofen appears in breast milk in very low concentrations and is unlikely to affect the breastfed infant adversely. Codeine is excreted in breast milk. The use of APOHealth Ibuprofen Plus Codeine tablets should be avoided, if possible during lactation.

Use in the elderly.

Ibuprofen should not be taken by adults over the age of 65 without careful consideration of comorbidities and comedications because of an increased risk of adverse effects, in particular heart failure, gastrointestinal ulceration and renal impairment.
The elderly are also more likely to have age related renal impairment and may be more susceptible to the respiratory depressant effects of codeine.

Interactions

The following interactions with ibuprofen and codeine have been noted.

ACE inhibitors, beta-blockers and diuretics.

Ibuprofen, like other NSAIDs may reduce the antihypertensive effect of ACE inhibitors and beta-blockers and diuretics and may cause natriuresis and hyperkalemia in patients under these treatments.

Anticholinergics.

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

Anticoagulant including warfarin.

buprofen interferes with the stability of INR and may increase the risk of severe bleeding and sometimes fatal haemorrhage, especially from the gastrointestinal tract. Ibuprofen should only be used in patients taking warfarin if absolutely necessary and they must be closely monitored.

Antihypertensives.

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

Antiperistaltic antidiarrhoeals (including kaolin, pectin, loperamide).

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

Cardiac glycosides.

NSAIDs may increase plasma glycoside levels.

Central nervous system depressants.

Concomitant use of codeine with central nervous system depressants (e.g. barbiturates, chloral hydrate, sedatives, alcohol and centrally acting muscle relaxants) can cause addictive CNS depression.

Corticosteroids.

An increased risk of gastrointestinal bleeding may occur with corticosteroids.

Lithium.

Ibuprofen may decrease the renal clearance and increase plasma concentrations of lithium. Lithium plasma concentrations should be monitored in patients on concurrent ibuprofen therapy.

Metoclopramide.

Codeine may antagonise the effects of metoclopramide on gastrointestinal motility.

Methotrexate.

Ibuprofen reduces methotrexate clearance. Use of high doses of methotrexate concomitantly with NSAIDs should be avoided and caution should be used if low doses of methotrexate are administered concomitantly with ibuprofen.

Monoamine oxidase inhibitors (MAOIs).

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

NSAIDs and aspirin.

Concurrent use of ibuprofen with aspirin or other NSAIDs can lead to increased gastrointestinal adverse effects.

Opioid analgesics.

Concurrent use of codeine and other opioid receptor agonists is usually inappropriate as additive CNS depression, respiratory depression and hypotensive effects may occur.

Antidiabetic medicines, probenecid and phenytoin.

Interactions may also occur with probenecid and phenytoin.

Drugs that inhibit CYP2D6.

Quinidine, phenothiazines can interfere with the metabolism of codeine to morphine, reducing the analgesic effect of codeine.

Tranquillizers, sedatives and hypnotics.

Codeine may potentiate the effects of these preparations.

Zidovudine.

Concurrent administration with ibuprofen may prolong bleeding time in patients.

Adverse Effects

Adverse effects with nonprescription (OTC) or short-term use of ibuprofen and codeine phosphate may include:

Gastrointestinal.

Dyspepsia, heartburn, nausea, vomiting, loss of appetite, diarrhoea, stomach pain, and constipation.

Skin.

Hypersensitivity reactions, skin rash and itching. Rarely exfoliative dermatitis and epidermal necrolysis have been reported with ibuprofen.

Renal.

Papillary necrosis, which can lead to renal failure.

Cardiovascular.

At OTC doses fluid retention and in some cases oedema occur rarely.

Other.

Hepatic dysfunction, headache, dizziness, hearing disturbance. Rarely, allergic reactions such swelling of the face, or breathing difficulties and rarely thrombocytopenia.

CNS.

Cough suppression, respiratory depression, dizziness and drowsiness.

Dosage and Administration

Adults and children 12 years and over.

Initial dose two tablets taken with fluid, then one or two tablets every 4 hours when necessary. Maximum dose is 6 tablets in a 24 hour period.

Children.

Not recommended for children under 12 years.

Overdosage

In case of overdose, immediately contact the Poisons Information Centre (in Australia call 131 126) for advice.

Ibuprofen.

Symptoms of overdose with ibuprofen include nausea, vomiting, abdominal pain, dizziness, drowsiness, nystagmus, blurred vision, tinnitus and rarely, metabolic acidosis and loss of consciousness.

Codeine.

Nausea and vomiting are prominent features of codeine overdose. Respiratory depression, excitability, convulsions, hypotension and loss of consciousness may occur with large codeine overdose.

Presentation

Tablets (white to off white, capsule shaped, biconvex, film coated, AUST R 227876): 20's, 30's.

Storage

Store below 30°C.

Poison Schedule

S3.