Consumer medicine information

Pharmacy Action Paracetamol & Ibuprofen

Paracetamol; Ibuprofen

BRAND INFORMATION

Brand name

Pharmacy Action Paracetamol & Ibuprofen

Active ingredient

Paracetamol; Ibuprofen

Schedule

S3 | S2

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Pharmacy Action Paracetamol & Ibuprofen.

FULL CMI

Pharmacy Action Paracetamol & Ibuprofen

Active ingredient(s): ibuprofen and paracetamol

Consumer Medicine Information (CMI)

This leaflet provides important information about using Pharmacy Action Paracetamol & Ibuprofen. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Pharmacy Action Paracetamol & Ibuprofen.

Where to find information in this leaflet:

1. Why am I using Pharmacy Action Paracetamol & Ibuprofen?
2. What should I know before I use Pharmacy Action Paracetamol & Ibuprofen?
3. What if I am taking other medicines?
4. How do I use Pharmacy Action Paracetamol & Ibuprofen?
5. What should I know while using Pharmacy Action Paracetamol & Ibuprofen?
6. Are there any side effects?
7. Product details

1. Why am I using Pharmacy Action Paracetamol & Ibuprofen?

Pharmacy Action Paracetamol & Ibuprofen contains the active ingredients ibuprofen and paracetamol. Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Paracetamol works to stop the pain messages from getting through to the brain.

Pharmacy Action Paracetamol & Ibuprofen is used as an analgesic (pain reliever). It works to relieve acute (short term) pain and/or inflammation associated with headache, migraine headache, tension headache, sinus pain, toothache, dental procedures, backache, muscular aches and pains, period pain, sore throat, tennis elbow, rheumatic pain and arthritis, and the aches and pains associated with colds and flu.

2. What should I know before I use Pharmacy Action Paracetamol & Ibuprofen?

Warnings

Do not use Pharmacy Action Paracetamol & Ibuprofen if:

  • you are allergic to:
    - ibuprofen;
    - paracetamol;
    - any other medicine for pain relief;
    - or any of the ingredients listed at the end of this leaflet.
    Always check the ingredients to make sure you can use this medicine.
    Some of the symptoms of an allergic reaction may include:
    - shortness of breath, wheezing or difficulty breathing;
    - swelling of the face, lips, tongue or other parts of the body;
    - rash, itching or hives on the skin.
  • liver or kidney disease;
  • heart problems;
  • asthma;
  • a stomach ulcer or duodenal ulcer or if you have had either of these conditions or gastric bleeding or other gastrointestinal diseases in the past;
  • recently vomited blood or material that looks like coffee grounds;
  • recently bled from the back passage (rectum), had black sticky bowel motions or bloody diarrhoea;
  • experienced liver problems. Some of the symptoms of liver problems may include:
    - nausea;
    - feeling tired;
    - itching of the skin;
    - yellow colouring of the skin;
    - flu-like symptoms;
    - tenderness in your abdomen.
    If you develop any of these symptoms or heart problems, talk to your doctor.
  • you are taking any other product containing paracetamol, ibuprofen or other NSAIDs or if you are taking any other medicine for pain relief.
  • the expiry date printed on the pack has passed or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

Check with your doctor or pharmacist if you:

  • have allergies to any other medicines, foods, preservatives or dyes;
  • have, or have had, any other medical conditions such as:
    - diabetes,
    - asthma,
    - liver or kidney disease,
    - heart problems;
  • take any medicines for any other condition;
  • are not sure whether you should start taking Pharmacy Action Paracetamol & Ibuprofen.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Do not take this medicine if you are pregnant or plan to become pregnant.

Talk to your doctor or pharmacist if you are breastfeeding or intend to breastfeed.

Small amounts of ibuprofen and paracetamol pass into the breast milk.

3. What if I am taking other medicines?

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

Some medicines may interfere with Pharmacy Action Paracetamol & Ibuprofen and affect how it works. These include:

  • warfarin, a medicine used to prevent blood clots;
  • lithium, a medicine used to treat mood swings and some types of depression;
  • medicines used to lower blood pressure;
  • methotrexate, a medicine used to treat arthritis and some types of cancer;
  • medicines used to treat heart failure;
  • medicines such as prednisone, prednisolone and cortisone, which reduce the activity of your immune system;
  • zidovudine, a medicine used to treat HIV infection;
  • aspirin, salicylates and other NSAIDs;
  • medicines used to treat diabetes;
  • metoclopramide, a medicine used to control nausea and vomiting;
  • medicines used to treat epilepsy or fits;
  • chloramphenicol, an antibiotic used to treat ear and eye infections;
  • alcohol.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Pharmacy Action Paracetamol & Ibuprofen.

4. How do I use Pharmacy Action Paracetamol & Ibuprofen?

How much to take / use

  • Adults under 65 and children from 12 years: Take one tablet every 8 hours with water when necessary.
  • Do not take more than 3 tablets in 24 hours.
  • Adults: do not take Pharmacy Action Paracetamol & Ibuprofen for more than 3 days at a time.
  • Adolescents (12 to 17 years): do not take Pharmacy Action Paracetamol & Ibuprofen for more than 2 days at a time.
  • Follow the instructions provided with the medicine.
  • Do not exceed the recommended dosage.

When to take Pharmacy Action Paracetamol & Ibuprofen

  • Pharmacy Action Paracetamol & Ibuprofen should be used when required for pain.
  • If your symptoms persist, worsen or new symptoms develop, talk to your pharmacist or doctor.

If you use too much Pharmacy Action Paracetamol & Ibuprofen

If you think that you have used too much Pharmacy Action Paracetamol & Ibuprofen, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26); or
  • contact your doctor; or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using Pharmacy Action Paracetamol & Ibuprofen?

Things you should do

  • Talk to your pharmacist or doctor if your symptoms do not improve. Your pharmacist or doctor will assess your condition and decide if you should continue to take the medicine.

Remind any doctor, dentist or pharmacist you visit that you are using Pharmacy Action Paracetamol & Ibuprofen.

Things you should not do

  • Do not take Pharmacy Action Paracetamol & Ibuprofen for more than 3 days at a time (2 days for adolescents 12 to 17 years) unless your doctor tells you to.
  • Do not take more than the recommended dose unless your pharmacist or doctor tells you to.
  • Do not take Pharmacy Action Paracetamol & Ibuprofen to treat any other complaints unless your pharmacist or doctor tells you to.
  • Do not give your medicine to anyone else, even if they have the same condition as you.
  • Do not take Pharmacy Action Paracetamol & Ibuprofen if you are aged 65 years or older.

Things to be careful of

  • Taking this medicine may increase the risk of you getting unwanted effects, such as stomach or heart problems

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Pharmacy Action Paracetamol & Ibuprofen affects you.

Drinking alcohol

Tell your doctor or pharmacist if you drink alcohol.

Only drink small quantities of alcohol (beer, wine or spirits) while taking paracetamol.

Drinking large quantities of alcohol while taking paracetamol may increase the risk of liver side effects.

Looking after your medicine

  • Keep your medicine in the original pack until it is time to take it.
  • Keep your medicine in a cool dry place where the temperature stays below 30°C.

Follow the instructions on the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

  • in the bathroom or near a sink; or
  • in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

It is rare to get side effects from ibuprofen and paracetamol if taken for a short period of time and in the doses for over-the-counter medicines.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions.

Less serious side effects

Less serious side effectsWhat to do
  • Nausea, heartburn, or stomach pain.
  • Loss of appetite.
  • Diarrhoea
  • Dizziness
  • Drowsiness
  • Headache
  • Nervousness
Speak to your doctor or pharmacist if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
Serious side effects:
  • if you get sunburnt more quickly than usual.
Very serious side effects:
  • Fluid retention.
  • Vomiting blood or bleeding from the back passage.
  • Shortness of breath.
  • Wheezing or difficulty breathing.
  • Swelling of the face, lips, tongue or other parts of the body.
  • Rash, itching or hives on the skin.
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

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

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

7. Product details

This medicine is available over-the-counter without a doctor's prescription.

What Pharmacy Action Paracetamol & Ibuprofen contains

Active ingredient
(main ingredient)		Ibuprofen
Paracetamol
Other ingredients
(inactive ingredients)		Pregelatinised maize starch
Povidone
Crospovidone
Microcrystalline cellulose
Colloidal anhydrous silica
Magnesium stearate
Hypromellose
Purified talc
Purified water
Titanium dioxide
OPADRY FX special effects film coating system 63F97546 SILVER
Potential allergensNot applicable

Do not take this medicine if you are allergic to any of these ingredients.

What Pharmacy Action Paracetamol & Ibuprofen looks like

Pharmacy Action Paracetamol & Ibuprofen tablets are white to off-white, oval-shaped, biconvex, film-coated, pearlescent tablets plain on both sides (AUST R 281501).

Who distributes Pharmacy Action Paracetamol & Ibuprofen

Generic Health Pty Ltd
Suite 2, Level 2
19-23 Prospect Street
Box Hill, VIC, 3128
Australia

ii1359001  [email protected]

ii1359002  +61 3 9809 7900

ii1359003  www.generichealth.com.au

This leaflet was prepared in October 2024.

Published by MIMS January 2025

BRAND INFORMATION

Brand name

Pharmacy Action Paracetamol & Ibuprofen

Active ingredient

Paracetamol; Ibuprofen

Schedule

S3 | S2

 

1 Name of Medicine

Paracetamol and ibuprofen.

2 Qualitative and Quantitative Composition

Each tablet contains paracetamol 500 mg and ibuprofen 200 mg.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Pharmacy Action Paracetamol & Ibuprofen tablets are white to off white, oval shaped, biconvex, film-coated pearlescent tablets plain on both sides.

4 Clinical Particulars

4.1 Therapeutic Indications

Temporary relief of acute (short term) pain and/or inflammation associated with headache, migraine headache, tension headache, sinus pain, toothache, dental procedures, backache, muscular aches and pains, period pain, sore throat, tennis elbow, rheumatic pain and arthritis, and the aches and pains associated with colds and flu. Reduces fever.

4.2 Dose and Method of Administration

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see Section 4.4 Special Warnings and Precautions for Use).

Adults under 65 and children over 12 years.

Take 1 tablet three times a day when necessary (every 8 hours). Maximum 3 tablets in 24 hours.
Keep to the recommended dose. Do not take for more than 3 days at a time (2 days for adolescents aged 12 to 17 years) unless on medical advice, in which case the patient should be reviewed regularly with regard to efficacy, risk factors and ongoing need for treatment.
Do not give to children under 12 years of age.
Not recommended for adults 65 years and over.

Pregnancy.

See Section 4.3 Contraindications; Section 4.6 Fertility, Pregnancy and Lactation.

Monitoring advice.

If symptoms persist please consult your healthcare professional.

4.3 Contraindications

Known hypersensitivity or idiosyncratic reaction to ibuprofen, paracetamol, or any other ingredients in the product listed in the description section above.
History of hypersensitivity reactions (e.g. bronchospasm, angioedema, rhinitis or urticaria) associated with aspirin or other anti-inflammatory drugs or analgesic drugs.
Asthma.
Pregnancy (see Section 4.6 Fertility, Pregnancy and Lactation).
History of, or active, gastrointestinal ulceration/perforation or bleed, or peptic ulceration, or other stomach disorder.
Impaired hepatic function, impaired renal function or heart failure.
Conditions that predispose to renal failure.
Taking other products containing ibuprofen, aspirin, salicylates or with other anti-inflammatory medicines (including NSAID products or cyclooxygenase-2 (COX-2) specific inhibitors) as there is an increased risk of adverse reactions (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Taking other products containing paracetamol, as there is an increased risk of serious adverse effects; patients should be advised not take with any other paracetamol containing products. Immediate medical advice should be sought if this occurs, even if they feel well, as this can result in an overdose. (See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.)
In patients aged 65 years and over and in children under 12 years.
In patients undergoing treatment of perioperative pain in setting of coronary artery bypass surgery (CABG).

4.4 Special Warnings and Precautions for Use

The hazard of paracetamol overdose is greater in patients with non-cirrhotic liver disease. Immediate medical advice should be sought in the event of an overdose, even if the patient feels well, because of the risk of delayed, serious liver damage. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.

Diabetes.

Caution is required in patients suffering from diabetes. Paracetamol falsely elevates continuous blood glucose monitor (CGM) readings compared to finger stick (BG meter) readings. This is applicable for those using CGM devices with or without an automated insulin delivery pump e.g. in type I diabetes.

Respiratory disorders.

Caution is required in patients with a history of bronchial asthma or allergic disease since NSAIDs have been reported to precipitate bronchospasm. The product is contraindicated in asthma (see Section 4.3 Contraindications).

Use in renal and hepatic impairment.

The administration of NSAIDs may cause a dose-dependent reduction in prostaglandin formation and precipitate renal failure. Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and the elderly. The product is contraindicated in patients with impaired renal or liver function or heart failure and in patients 65 years of age or older (see Section 4.3 Contraindications). Renal function should be monitored in other at-risk patients.
As with other NSAIDs elevations of one or more liver function tests may occur in up to 15% of patients. These abnormalities may progress, may remain essentially unchanged or may resolve with continued therapy. Meaningful elevations (three times the upper limit of normal) of ALT or AST occurred in controlled clinical trials in less than 1% of patients.
Patients should be advised to remain alert for hepatotoxicity and be informed about the signs and/or symptoms of hepatotoxicity (e.g. nausea, fatigue, lethargy, pruritus, jaundice, abdominal tenderness in the right upper quadrant and "flu-like" symptoms).

Cardiovascular and cerebrovascular effects.

Observational studies have indicated that NSAIDs may be associated with an increased risk of serious cardiovascular events, including myocardial infarction and stroke, which may increase with dose or duration of use.
Patients with cardiovascular disease, history of atherosclerotic cardiovascular disease or cardiovascular risk factors may also be at greater risk.
Patients should be advised to remain alert for such cardiovascular events, even in the absence of previous cardiovascular symptoms. Patients should be informed about signs and/or symptoms of serious cardiovascular toxicity and the steps to take if they occur.
Fluid retention, hypertension and oedema have been reported in association with NSAID therapy. Patients taking antihypertensives with NSAIDs may have an impaired antihypertensive response. Appropriate monitoring and advice are required for patients with a history of hypertension. The product is contraindicated in patients with heart failure (see Section 4.3 Contraindications).
Clinical data suggest that the use of ibuprofen, particularly at high doses (2400 mg daily) may be associated with an increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g. < 1200 mg daily) is associated with an increased risk of myocardial infarction.
Patients with uncontrolled hypertension, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with this product after careful consideration. Similar consideration should be made before initiating treatment for patients with risk factors for cardiovascular events (e.g. hypertensions, hyperlipidaemia, diabetes mellitus and smoking). The product is contraindicated in heart failure (see Section 4.3 Contraindications).

Gastrointestinal bleeding, ulceration and perforation.

Gastrointestinal (GI) bleeding, ulceration and perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events.
Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors (SSRIs) or antiplatelet agents.
The product is contraindicated in patients with a history of GI toxicity including ulceration (see Section 4.3 Contraindications).
Treatment with this product should be stopped if GI bleeding or ulceration occurs.

SLE and mixed connective tissue disease.

In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disease disorders there may be an increased risk of aseptic meningitis.

Skin and subcutaneous tissue disorders.

Serious skin reactions, some of them fatal including exfoliative dermatitis, Stevens-Johnson syndrome, drug reaction with eosinophilia with systemic symptoms (see Drug reaction with eosinophilia with systemic symptoms (DRESS)) and toxic epidermal necrolysis (TEN), have been reported very rarely in association with the use of NSAIDs and paracetamol. Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. Use of this product should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Severe skin reactions.

Severe skin reactions such as acute generalised exanthematous pustulosis (AGEP) may occur with ibuprofen-containing products. The acute pustular eruption may occur with ibuprofen-containing products. The acute pustular eruption may occur within the first 2 days of treatment, with fever, and numerous, small, mostly non-follicular pustules arising on a widespread oedematous erythema and mainly localised on the skin folds, trunk, and upper extremities. Patients should be carefully monitored. If signs and symptoms such as pyrexia, erythema, or many small pustules are observed, administration of this product should be discontinued and appropriate measures taken if needed.

Drug reaction with eosinophilia with systemic symptoms (DRESS).

DRESS has been reported in patients using NSAIDs. Some of these events have been fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling. Other clinical manifestations may include hepatitis, nephritis, haematological abnormalities, myocarditis, or myositis. Sometimes symptoms of DRESS may resemble an acute viral infection. Eosinophilia is often present. Because this disorder is variable in its presentation, other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, discontinue the NSAID and evaluate the patient immediately.

Masking of symptoms of underlying infections.

This product can mask symptoms of infection, which may lead to delayed initiation of appropriate treatment and thereby worsening the outcome of the infection. This has been observed in bacterial community acquired pneumonia and bacterial complications to varicella. When this product is administered for fever or pain relief in relation to infection, monitoring of infection is advised. In non-hospital settings, the patient should consult a doctor if symptoms persist or worsen.

Paediatric use.

This product is contraindicated in children under 12 years of age (see Section 4.3 Contraindications).

Use in the elderly.

This product is contraindicated in adults aged 65 years and over.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

This product is contraindicated in combination with:

Aspirin (acetylsalicylic acid).

Unless low-dose acetylsalicylic acid (not above 75 mg daily) has been advised by a doctor, as this may increase the risk of adverse reactions (see Section 4.4 Special Warnings and Precautions for Use). Experimental data suggests that ibuprofen may inhibit the effect of low dose acetylsalicylic acid on platelet aggregation when they are dosed concomitantly. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use (see Section 5.1 Pharmacodynamic Properties).

Other paracetamol containing products.


Other NSAIDs including cyclo-oxygenase-2 selective inhibitors.


Other anti-inflammatories and analgesics.

As concomitant use may increase the risk of adverse reactions.

Paracetamol.

This product (like any other paracetamol containing products) should be used with caution in combination with:

Chloramphenicol.

Increased plasma concentration of chloramphenicol.

Cholestyramine.

The speed of absorption of paracetamol is reduced by cholestyramine. Therefore, cholestyramine should not be taken within one hour if maximal analgesia is required.

Metoclopramide and domperidone.

The absorption of paracetamol is increased by metoclopramide and domperidone. However, concurrent use need not be avoided.

Warfarin.

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.
Paracetamol absorption is decreased by drugs which decrease gastric emptying, e.g. propantheline, antidepressants with anticholinergic properties and narcotic analgesics.
The likelihood of paracetamol toxicity may be increased by the concomitant use of other hepatotoxic drugs or liver microsomal enzyme inducing agents, such as alcohol or antiepileptic drugs.
Paracetamol excretion may be affected and plasma concentrations altered when given with probenecid.

Ibuprofen.

This product (like any other ibuprofen containing products and NSAIDs) should be used with caution in combination with:

Anticoagulants.

NSAIDs may enhance the effects of anticoagulants, i.e. warfarin.

Anti-hypertensives.

NSAIDs may reduce the effects of these drugs.
Safety updates and minor.

Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs).

Increased risk of gastrointestinal bleeding and increase plasma glycoside levels.

Cardiac glycosides.

NSAIDs may exacerbate cardiac failure, reduce glomerular filtration rate (GFR) and increase plasma glycoside levels.

Ciclosporin.

Increased risk of nephrotoxicity.

Corticosteroids.

Increased risk of gastrointestinal bleeding may occur with corticosteroids.

Diuretics.

Reduced diuretic effect. Diuretics may increase the risk of nephrotoxicity of NSAIDs.

Lithium.

Decreased elimination of lithium.

Methotrexate.

Decreased elimination of methotrexate.

Mifepristone.

NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone.

Quinolone antibiotics.

Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have increased risk of developing convulsions.

Tacrolimus.

Possible increase in nephrotoxicity when NSAIDs are given with tacrolimus.

Zidovudine.

Increased risk of haematological toxicity when NSAIDS are given concomitantly with zidovudine. There is evidence of an increased risk of haemarthrosis and haematoma in HIV + haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

The use of the product may impair female fertility and is not recommended in women attempting to conceive.
(Category C)
Drugs which owing to their pharmacological effects have caused or may be suspected of causing harmful effects on the human foetus or neonate without causing malformation. These effects may be reversible.
There is no experience of use of this product in humans during pregnancy. Therefore this product is contraindicated for use during pregnancy.
Congenital abnormalities have been reported in association with NSAID administration in man; however, these are low in frequency and do not appear to follow any discernible pattern. Use of NSAIDs during the last trimester of pregnancy may cause effects on the foetal cardiovascular system (risk of closure of ductus arteriosus), and the onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child.
Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol use at the recommended dosage.

Oligohydramnios and neonatal renal impairment.

Use of NSAIDs from about 20 weeks gestation may cause neonatal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.
These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation. Oligohydramnios is often, but not always, reversible with treatment discontinuation.
Complications of prolonged oligohydramnios may, for example, include limb contractures and delayed lung maturation. In some post-marketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required.
If, after careful consideration of alternative treatment options for pain management, NSAID treatment is necessary from about 20 weeks, limit use to the lowest effective dose and shortest duration possible. Consider ultrasound monitoring of amniotic fluid if treatment extends beyond 48 hours. Discontinue treatment with NSAIDs if oligohydramnios occurs.
 Ibuprofen and its metabolites can pass in very small amounts (0.0008% of the maternal dose) into the breast milk. No harmful effects to infants are known.
Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breastfeeding.
Therefore it is not necessary to interrupt breastfeeding for short term treatment with the recommended dose of this product.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Clinical trials with this product have not indicated any other undesirable effects other than those for ibuprofen or paracetamol alone.
In clinical trials, the product administered in single or multiple doses was shown to have a safety profile comparable to that of placebo. The percentage of subjects who experienced side effects, as well as the individual side effects seen, were similar to the well documented profiles of paracetamol and ibuprofen administered alone.
The following is a list of adverse effects from pharmacovigilance data experienced by patients taking ibuprofen alone or paracetamol alone in short term and long term use.
Adverse events may be minimized by using the minimum effective dose for the shortest duration necessary to control symptoms.

Common (occur in > 1% and < 10%).

Gastrointestinal.

Abdominal pain, diarrhoea, dyspepsia, nausea, stomach discomfort and vomiting.

Investigations.

Alanine aminotransferase increased, gamma glutamyl transferase increased and liver function tests abnormal with paracetamol. Blood creatinine increased and blood urea increased.

Skin and subcutaneous tissue disorders.

Hyperhidrosis.

Uncommon (occur in > 0.1% and < 1%).

Immune system disorders.

Hypersensitivity with urticaria and pruritus.

Gastrointestinal.

Flatulence and constipation, peptic ulcer, perforation or gastrointestinal haemorrhage, with symptoms of melaena, haematemesis sometimes fatal, particularly in the elderly. Ulcerative stomatitis and exacerbation of ulcerative colitis and Crohn's disease. Less frequently gastritis has been observed and pancreatitis reported.

Skin and subcutaneous tissue disorders.

Rashes of various types (including urticarial) and pruritus. Angioedema and swelling face. Acute generalised exanthematous pustulosis.

Investigations.

Aspartate aminotransferase increased, blood alkaline phosphatase increased, blood creatine phosphokinase increased, blood creatinine increased, haemoglobin decreased and platelet count increased.

Nervous system disorders.

Headache and dizziness.

Rare.

Cardiac disorders.

Fluid retention and oedema.

Very rare (occur in < 0.01%).

Blood and lymphatic system disorders.

Haematopoietic disorders (agranulocytosis, anaemia, aplastic anaemia, haemolytic anaemia, leucopaenia, neutropaenia, thrombocytopaenia and pancytopaenia). First signs are fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising and nose bleeds.

Immune system disorders.

Hypersensitivity reactions have been reported. These may consist of nonspecific allergic reactions and anaphylaxis. Symptoms of severe hypersensitivity reactions can include facial, tongue and larynx swelling, dyspnoea, tachycardia, hypotension, anaphylaxis, angioedema or severe shock.

Psychiatric disorders.

Confusion, depression and hallucinations.

Nervous system disorders.

Paraesthesia, optic neuritis and somnolence. Single cases of aseptic meningitis in patients with existing autoimmune disorders (e.g. systemic lupus erythematosus and mixed connective tissue disease) during treatment with ibuprofen, with symptoms such as stiff neck, headache, nausea, vomiting, fever or disorientation have been observed.

Eye disorders.

Visual disturbance.

Ear and labyrinth disorders.

Tinnitus and vertigo.

Cardiac disorders.

Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment. Clinical trial and epidemiological data suggest that use of ibuprofen, particularly at high doses (2400 mg daily), and in long term treatment may be associated with a small increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke, particularly with higher doses and longer duration of use, and in the elderly).

Respiratory, thoracic and mediastinal disorders.

Respiratory reactivity including asthma, exacerbation of asthma, bronchospasm and dyspnoea.

Hepatobiliary disorders.

Abnormal liver function, hepatitis and jaundice. In overdose, paracetamol can cause acute hepatic failure, hepatic failure, hepatic necrosis and liver injury.

Skin and subcutaneous tissue disorders.

Purpura and photosensitivity. Exfoliative dermatoses. Bullous reactions including bullous erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis.

Renal and urinary disorders.

Nephrotoxicity in various forms, including interstitial nephritis, nephrotic syndrome, and acute and chronic renal failure.

General disorders and administration site conditions.

Fatigue and malaise.

Unknown frequency.

Gastrointestinal.

Heartburn, loss of appetite.

Nervous system disorders.

Nervousness.

Pregnancy, puerperium and perinatal conditions.

Oligohydramnios, neonatal renal impairment.

Skin and subcutaneous tissue disorders.

Drug reaction with eosinophilia with systemic symptoms (DRESS), acute generalised exanthematous pustulosis (AGEP) and photosensitivity reactions.
Hypersensitivity reactions have been reported following treatment with both paracetamol and ibuprofen. These may consist of:
a) Non-specific allergic reactions and anaphylaxis. Allergic reactions such as skin rash, itching, swelling of the face or breathing difficulties may also occur. These are usually transient and reversible on cessation of treatment.
b) Respiratory tract reactivity e.g. asthma, aggravated asthma, bronchospasm and dyspnoea.
c) Assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angioedema and more rarely bullous dermatoses (including toxic epidermal necrolysis and bullous erythema multiforme).

Reporting suspected adverse effects.

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

4.9 Overdose

Symptoms.

Paracetamol.

Liver damage is possible in adults who have taken 10 g (equivalent to 20 tablets) or more of paracetamol. Ingestion of 5 g (equivalent to 10 tablets) or more of paracetamol may lead to liver damage if the patient has one or more of the risk factors below:
a) Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's wort or other drugs that induce liver enzymes.
b) Regularly consumes alcohol in excess of recommended amounts.
c) Is likely to be glutathione depleted e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
Toxic symptoms include vomiting, abdominal pain, anorexia, pallor hypotension, sweating, central stimulation with exhilaration and convulsions in children, drowsiness, respiratory depression, cyanosis and coma. Liver damage may become apparent 12 to 48 hours after ingestion as liver function tests become abnormal. Abnormalities of glucose metabolism and metabolic acidosis may occur. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported. The most serious adverse effect of acute overdosage of paracetamol is a dose dependent in severe poisoning, in which hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema and death.
In adults, hepatotoxicity may occur after ingestion of a single dose of paracetamol 10 to 15 g; a dose of 25 g 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.

Ibuprofen.

Symptoms of overdose with ibuprofen include nausea, vomiting, abdominal pain, and diarrhoea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more serious poisoning, toxicity is seen in the central nervous system, manifesting as drowsiness, occasionally excitation and disorientation or coma. Occasionally patients develop convulsions. In serious poisoning, metabolic acidosis may occur and prolong the prothrombin time (PT) and increase the international normalised ratio (INR), probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur if there is co-incident dehydration. Exacerbation of asthma is possible in asthmatics. Other symptoms may include: dizziness, nystagmus, blurred vision, tinnitus and rarely, metabolic acidosis and loss of consciousness.

Treatment.

Management of paracetamol overdose.

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines.
Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable).
Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however the maximum protective effect is obtained up to 8 hours post- ingestion. The effectiveness of the antidote declines sharply after this time.
If required, the patient should be given intravenous N-acetylcysteine in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital.
Patients who present with serious hepatic dysfunction beyond 24 hours from ingestion should be managed in accordance with established guidelines.

Management of ibuprofen overdose.

Management should be symptomatic and supportive and include the maintenance of a clear airway and monitoring of cardiac and vital signs until stable. Consider oral administration of activated charcoal if the patient presents within 1 hour of ingestion of a potentially toxic amount. If frequent or prolonged, convulsions should be treated with intravenous diazepam or lorazepam. Give bronchodilators for asthma.
If an overdose is taken or suspected, immediately contact the Poisons Information Centre (in Australia, call 13 11 26; in New Zealand call 0800 764 766) for advice, or go to a hospital straight away even if you feel well because of the risk of delayed, serious liver damage.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

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.
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 cyclo-oxygenases and subsequent prostaglandin synthetase inhibition.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

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 metabolised differently by infants and children compared to adults, the sulfate conjugate being predominant.
A minor hydroxylated metabolite, which is usually produced in very small amounts by mixed function oxidases in the liver and detoxified by conjugation with liver glutathione, may accumulate following paracetamol overdose and cause liver damage.
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.

Ibuprofen.

It is well absorbed from the gastrointestinal tract after oral administration with peak serum levels occurring after 1-2 hours. It is highly bound (90-99%) to plasma proteins and consequently, this characteristic of the drug should be considered when prescribing ibuprofen together with other drugs that bind to the same site on human serum albumin.
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.
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. 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. The elimination half-life of ibuprofen is in the range of 1.9 to 2.2 hours.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Pregelatinised maize starch, povidone, crospovidone, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, hypromellose, purified talc, purified water, titanium dioxide and Opadry fx special effects film coating system 63F97546 silver.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

The products are available in PVC/PVDC/Al blister packs of 4, 5, 6, 8, 10, 12, 16, 20, 24 and 30 tablets.*
* Not all pack sizes are marketed.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Paracetamol is a white or almost white crystalline powder. It is sparingly soluble in water, freely soluble in alcohol, very slightly soluble in methylene chloride. Paracetamol is an analgesic and antipyretic.
Ibuprofen 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.

Chemical structure.

Paracetamol.


Molecular Formula: C8H9NO2.
Molecular Weight: 151.2.

Ibuprofen.


Molecular Formula: C13H18O2.
Molecular Weight: 206.3.

CAS number.

Paracetamol.

103-90-2.

Ibuprofen.

15687-27-1.

7 Medicine Schedule (Poisons Standard)

(S3) Pharmacist only medicine - packs of 16, 20, 24 and 30 tablets.
(S2) Pharmacy medicine - packs of 4, 5, 6, 8, 10 and 12 tablets.

Summary Table of Changes