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.

What is in this leaflet

This leaflet answers some common questions about PHARMACY ACTION Paracetamol & Ibuprofen. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor or pharmacist has weighed the risks of you taking PHARMACY ACTION Paracetamol & Ibuprofen against the benefits this medicine is expected to have for you.

If you have any concerns about taking this medicine, ask your pharmacist or doctor.

Keep this information with the medicine. You may need to read it again.

What PHARMACY ACTION Paracetamol & Ibuprofen is used for

PHARMACY ACTION Paracetamol & Ibuprofen contains two ingredients, paracetamol and ibuprofen, that together deliver temporary relief of acute (short term) pain and/or inflammation associated with back pain, dental pain, period pain, migraine headache, cold and flu symptoms, tension headache, muscular pain, headache, sore throat, rheumatic pain and non-serious arthritic pain.

Paracetamol works to stop the pain messages from getting through to the brain.

Paracetamol also acts in the brain to reduce fever.

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.

Your doctor or pharmacist may have given you this medicine for another use.

PHARMACY ACTION Paracetamol & Ibuprofen is not recommended for children under 12 years of age.

If you want more information, ask your doctor or pharmacist.

Before you take PHARMACY ACTION Paracetamol & Ibuprofen

When you must not take it

You should not take PHARMACY ACTION Paracetamol & Ibuprofen if you are allergic to:

  • paracetamol or ibuprofen, aspirin, other NSAIDs;
  • any of the ingredients listed under ‘Product Description’.

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;
  • stomach ache, fever, chills, nausea and vomiting, fainting.

If you are allergic to aspirin or NSAID medicines and take PHARMACY ACTION Paracetamol & Ibuprofen, these symptoms may be severe.

Do not take PHARMACY ACTION Paracetamol & Ibuprofen if you are also taking any other medicines that contain one or more NSAID medicines, 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.

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

Ibuprofen should not be taken at all during the last 3 months of pregnancy including the last few days before expected birth.

Unless advised by a medical doctor, do not take ibuprofen during the first 6 months of pregnancy.

Do not take this medicine if you have any of the following conditions:

  • asthma, bronchitis, emphysema or other acute breathing difficulties;
  • bleeding from the rectum (back passage), have black sticky bowel motions (stools) or bloody diarrhoea;
  • if you have a stomach ulcer;
  • recent vomiting of blood or material that look like coffee grounds;
  • liver or kidney disease;
  • heart problems.

Do not take this medicine if you regularly drink large quantities of alcohol.

Ask your doctor or pharmacist about taking PHARMACY ACTION Paracetamol & Ibuprofen if you are breastfeeding.

Do not use PHARMACY ACTION Paracetamol & Ibuprofen in children under 12 years of age.

Ask your doctor or pharmacist about taking PHARMACY ACTION Paracetamol & Ibuprofen tablets if you are over 65 years of age and have kidney or respiratory problems.

Do not use it after the expiry date (EXP) printed on the pack has passed. If you take it after the expiry date it may have no effect at all, or worse, have an entirely unexpected effect.

Do not use PHARMACY ACTION Paracetamol & Ibuprofen if the packaging is torn or shows signs of tampering.

Before you start to take it

Do not take PHARMACY ACTION Paracetamol & Ibuprofen with other medicines containing paracetamol or ibuprofen, aspirin, salicylates or with any other anti-inflammatory medicines, unless advised to do so by a doctor or pharmacist.

You must tell your pharmacist or doctor if:

  • you have allergies to any ingredients listed under ‘Product Description’ at the end of this leaflet.
  • you have ever had any of these conditions:
    - liver, kidney or heart problems;
    - asthma, or have suffered in the past from asthma.
  • you drink large quantities of alcohol.
  • you have a history of drug or alcohol abuse.
  • you have had recent surgery on the stomach or intestines.
  • you have a previous history of ulcers.

If you currently have any of these conditions you should not take this medicine. Ask your pharmacist about taking this medicine if you are breastfeeding. Small amounts of ibuprofen and paracetamol pass into the breast milk.

Taking other medicines

Tell your pharmacist or doctor if you are using any other medicines including any of the following medicines:

  • aspirin, salicylates or other NSAID medicines;
  • warfarin or other medicines used to stop blood clots or thin the blood;
  • 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 to treat epilepsy
  • metoclopramide, a medicine used to control nausea and vomiting;
  • propantheline, a drug used to treat stomach ulcers;
  • chloramphenicol, an antibiotic used to treat ear and eye infections;
  • medicines used to relieve stomach cramps or spasms;
  • medicines such as prednisone, prednisolone and cortisone, which reduce the activity of your immune system;
  • probenecid, a drug used to treat high uric acid levels in blood associated with gout;
  • cholestyramine, a drug used to reduce blood cholesterol;
  • methotrexate, a medicine used to treat arthritis and some types of cancer;
  • diuretics also call fluid tablets;
  • medicines used to treat high blood pressure or other heart conditions.

These medicines may be affected by PHARMACY ACTION Paracetamol & Ibuprofen or affect how well PHARMACY ACTION Paracetamol & Ibuprofen works.

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

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

If you have not told your pharmacist or doctor about any of these things, tell him/her before you take any PHARMACY ACTION Paracetamol & Ibuprofen.

How to take PHARMACY ACTION Paracetamol & Ibuprofen

The label on your pack of PHARMACY ACTION Paracetamol & Ibuprofen 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

The usual dose of PHARMACY ACTION Paracetamol & Ibuprofen is:

Adults and children over 12 years: Take 1 tablet three times a day when necessary (every 8 hours).

How to take it

Swallow the tablet whole with a little water or other liquid.

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.

How long to take it

Adults: Do not take this medicine for longer than 3 days at a time, unless advised to by a doctor.

Adolescents 12–17 years: Do not take this medicine for longer than 2 days at a time, unless advised to by a doctor.

Do not take more than 3 tablets in a 24-hour period.

Keep to the recommended dose. If PHARMACY ACTION Paracetamol & Ibuprofen is not adequately controlling your pain, do not increase the dose. Please see your doctor.

Do not give this medicine to children under 12 years of age.

As with other NSAIDs, excessive or prolonged use of ibuprofen may increase the risk of heart attack, stroke or liver damage.

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

If you take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone in Australia 13 11 26, telephone in NZ 0800 764 766) for advice or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much PHARMACY ACTION Paracetamol & Ibuprofen.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention because of the risk of delayed, serious liver damage with an overdose of paracetamol.

Keep telephone numbers of these places handy.

If you take too many tablets you may feel nauseous or have upset stomach, experience vomiting and gastric irritation, feel light-headed, dizzy or drowsy. Excitability, convulsions and unconsciousness may be experienced in rare cases.

While you are taking PHARMACY ACTION Paracetamol & Ibuprofen

Things you must do

Take PHARMACY ACTION Paracetamol & Ibuprofen exactly as your pharmacist or doctor has told you to.

Tell all your doctors, dentists and pharmacists that you are taking PHARMACY ACTION Paracetamol & Ibuprofen.

Tell your doctor or pharmacist if you become pregnant while taking PHARMACY ACTION Paracetamol & Ibuprofen.

Things you must not do

Do not use this medicine to treat any other complaint unless your doctor or pharmacist says it is safe. Do not give this medicine to anyone else even if they have the same symptoms as you.

Adults: Do not take this medicine for longer than 3 days at a time, unless advised to by a doctor.

Adolescents 12–17 years: Do not take this medicine for longer than 2 days at a time, unless advised to by a doctor.

Do not give this medicine to children under 12 years of age.

Do not take more than the recommended dose unless your doctor tells you to.

Do not take this medicine if you are taking other medicines that contain aspirin, paracetamol, ibuprofen, salicylates or other anti-inflammatory medicines or other medicines for pain relief.

Things to be careful of

PHARMACY ACTION Paracetamol & Ibuprofen 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.

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

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while taking PHARMACY ACTION Paracetamol & Ibuprofen.

Like other medicines, PHARMACY ACTION Paracetamol & Ibuprofen can cause some side effects. If they occur, they are most likely minor and temporary. However, sometimes they are serious and need medical treatment.

Ask your doctor or pharmacist to answer any questions you may have.

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

  • nausea;
  • vomiting;
  • stomach pain;
  • diarrhoea;
  • heartburn, indigestion;
  • dizziness;
  • light-headedness;
  • drowsiness.

Be careful driving or operating machinery until you know how PHARMACY ACTION Paracetamol & Ibuprofen affects you.

The above list includes the more common side effects of your medicine. They are usually mild.

Tell your doctor as soon as possible if you notice any of the following:

  • skin rashes;
  • yellowing of the skin and eyes also called jaundice;
  • painful red areas with blisters and peeling layers of skin which may be accompanied by fever and/or chills;
  • flushing of the face;
  • fast heartbeat.

The above list includes serious side effects that may require medical attention. Serious side effects are rare for low doses of this medicine and when used for a short period of time.

If any of the following happen, stop taking PHARMACY ACTION Paracetamol &Ibuprofen and tell your pharmacist or doctor immediately or go to Accident and Emergency at your nearest hospital:

  • 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;
  • swelling of other parts of the body;
  • asthma, wheezing, shortness of breath, pain or tightness in the chest;
  • sudden or severe itching, skin rash, hives, skin peeling.

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.

If you believe PHARMACY ACTION Paracetamol & Ibuprofen is not working well for you, do not increase the dose.Please see your pharmacist or doctor.

Some people may get other side effects not listed above.

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

After taking PHARMACY ACTION Paracetamol & Ibuprofen

Storage

Keep your tablets in the blister pack until it is time to take them. If you take the tablets out of the box or the blister pack they will not keep well.

Keep PHARMACY ACTION Paracetamol & Ibuprofen in a cool dry place where the temperature stays below 25°C. Heat and dampness can destroy some medicines.

Do not leave PHARMACY ACTION Paracetamol & Ibuprofen in the car on hot days.

Do not store PHARMACY ACTION Paracetamol & Ibuprofen or any other medicine in the bathroom or near a sink.

Keep PHARMACY ACTION Paracetamol & Ibuprofen where young 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 pharmacist or doctor tells you to stop taking the tablets, ask your pharmacist what to do with any tablets that are left over.

This is not all the information that is available on PHARMACY ACTION Paracetamol & Ibuprofen. If you have any more questions or are not sure about anything, ask your doctor or pharmacist.

Product description

What it looks like

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

It is available in packs of 4, 5, 6, 8, 10, 12, 20, 24 and 30 tablets.*

* Not all pack sizes are marketed.

Ingredients

Active ingredients

Each tablet contains:

  • 500 mg paracetamol;
  • 200 mg ibuprofen.

Other 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.

PHARMACY ACTION Paracetamol & Ibuprofen tablets do not contain any gluten, lactose, wheat or sucrose.

Australian Registration Numbers

PHARMACY ACTION Paracetamol & Ibuprofen: AUST R 281501.

Sponsor

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

Email: [email protected]
Telephone: +61 3 9809 7900
Website: www.generichealth.com.au

This leaflet was prepared in October 2020.

Published by MIMS December 2022

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