Consumer medicine information

Ibupane

Paracetamol; Ibuprofen

BRAND INFORMATION

Brand name

Ibupane

Active ingredient

Paracetamol; Ibuprofen

Schedule

S3 | S2

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Ibupane.

FULL CMI

IBUPANE®

Active ingredient(s): paracetamol and ibuprofen


Consumer Medicine Information (CMI)

This leaflet provides important information about using IBUPANE. 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 IBUPANE.

Where to find information in this leaflet:

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

1. Why am I using IBUPANE?

IBUPANE contains two active ingredients paracetamol and ibuprofen. IBUPANE belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). This group of medicines work by relieving pain, inflammation (swelling, redness, soreness) and fever. Paracetamol works to stop the pain messages from getting through to the brain and also acts in the brain to reduce fever.

IBUPANE is used for 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.

2. What should I know before I use IBUPANE?

Warnings

Do not use IBUPANE if you are allergic to paracetamol, ibuprofen, aspirin, other NSAIDs or any of the ingredients listed at the end of this leaflet.

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 NSAIDs medicines and take IBUPANE tablets these symptoms may be severe.

Always check the ingredients to make sure you can use this medicine.

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

  • Heart problems
  • Liver or kidney disease
  • 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 or duodenal ulcer or if you have had either of these conditions or gastric bleeding or other gastrointestinal diseases in the past
  • If you have had bleeding episodes which cannot be explained
  • Recent vomiting of blood or material that look like coffee grounds
  • Some of the symptoms of liver problems may include:
    - Nausea
    - Feeling tired
    - Itching of the skin
    - Yellow colouring of your skin
    - “Flu-like” symptoms
    - Tenderness in your abdomen

If you develop any of these symptoms or heart problems, talk to your doctor.

Do not take IBUPANE tablets if you are also taking any other medicines that contain one or more NSAID medicine or if you are taking any other medicine for pain relief, 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 give IBUPANE tablets to children aged under 12 years.

Do not take if you are aged 65 years or older.

Do not give IBUPANE tablets to dehydrated adolescents.

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

Check with your doctor or pharmacist if you:

  • have allergies to any ingredients listed under "Product Details" at the end of this leaflet.
  • have severe skin reactions such as extensive skin rash known as DRESS with following reactions such as fever, rash, enlargement of lymph nodes and/or facial swelling, kidney problems, blood disorder, inflammation of the heart, muscle weakness/pain
  • suffer from hayfever, nasal polyps or have chronic respiratory disorders. These may increase the risk of an allergic reaction occurring.
  • Have, or have 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 or drug or alcohol abuse
    - Recent surgery on the stomach or intestines
    - Previous history of ulcers
    - Diabetes
    - Autoimmune problems (where your own immune system mistakenly attacks substances naturally occurring in your body)
    - Have recently had major surgery
    - have a metabolic disorder
    - have a blood platelet disorder

If you currently have any of these conditions you should not take this medicine.

  • take any medicines for any other condition
  • are breastfeeding or planning to breast-fed.
  • are over 65 years of age and have kidney or respiratory problems
  • are not sure whether you should start taking IBUPANE.

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.

Like most medicines of this kind, IBUPANE is not recommended to be used during pregnancy.

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

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

Use of IBUPANE may cause the baby to have kidney problems leading to a low amount of amniotic fluid inside the uterus and in some cases kidney problems in the newborn.

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 IBUPANE and affect how it works. These include:

  • other paracetamol containing products, analgesics, other medicines for pain relief
  • Aspirin, salicylates or other NSAID medicines.
  • Warfarin or other medicines used to stop blood clots or thin the blood.
  • antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs)
  • Zidovudine a medicine used to treat HIV infection.
  • Lithium and other medicines used to treat depression or anxiety e.g. MAOIs (even if taken within the last 14 days).
  • Medicines to treat epilepsy or fits
  • 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
  • Corticosteroids such as prednisone, prednisolone and cortisone, which reduce the activity of your immune system
  • Probenecid, as drug used to treat high uric acid levels in blood associated with gout
  • Colestyramine, as drug used to reduce blood cholesterol
  • Methotrexate, a medicine used to treat arthritis and some types of cancer
  • Diuretics, also called fluid tablets
  • Alcohol
  • Medicines used to treat high blood pressure or heart failure or other heart conditions
  • Medicines used to treat diabetes. These medicines may be affected by IBUPANE tablets or affect how well IBUPANE tablets work.

IBUPANE may hide signs of infections such as fever and pain. It is therefore possible that IBUPANE may delay appropriate treatment of infection, which may lead to an increased risk of complications.

This has been observed in patients with serious lung infections (also called pneumonia) caused by bacteria and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and your symptoms of the infection persist or worsen, consult a doctor without delay.

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

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

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect IBUPANE.

4. How do I use IBUPANE?

How much to take

  • Adults under 65 and children over 12 years:
    - 1 tablet three times a day when necessary (every 8 hours).
  • Follow the instructions provided and use IBUPANE until your doctor tells you to stop.
  • Do not exceed the recommended dosage.
    - 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.

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.

How to take IBUPANE

  • Swallow 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.

If you use too much IBUPANE

If you think that you have used too much IBUPANE, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (Australia telephone 13 11 26) for advice, 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.

You may need urgent medical attention because of the risk of delayed, serious liver damage and kidney failure with an overdose of paracetamol and ibuprofen.

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.

5. What should I know while using IBUPANE?

Things you should do

Take IBUPANE tablets exactly as your pharmacist or doctor has told you to.

If IBUPANE tablets are not adequately controlling your pain, do not increase the dose. Please talk to your doctor or pharmacist if your symptoms do not improve. Your doctor or pharmacist will assess your condition and decide if you should continue to take the medicine.

Tell your doctor or pharmacist if you become pregnant while taking IBUPANE tablets.

Remind any doctor, dentist or pharmacist you visit that you are using IBUPANE.

Things you should not do

  • Do not give this medicine to children under 12 years of age or for adults 65 years of age and over.
  • Do not take this medicine for longer than 3 days at a time (2 days for adolescents 12 to 17 years) unless advised to by a doctor.
  • Do not take more than the recommended dose unless your doctor or pharmacist tells you to.
  • Do not use this medicine to treat any other complaint unless your doctor or pharmacist tells you to.
  • Do not give your medicine to anyone else even if they have the same symptoms as you.
  • 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

  • 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 IBUPANE affects you.

IBUPANE 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.

Drinking alcohol

Tell your doctor or pharmacist if you drink alcohol.

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

Looking after your medicine

  • Keep your tablets in the blister pack until it is time to take them.
  • Keep IBUPANE tablets in a cool dry place where the temperature stays below 25°C.

Follow the instructions in 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.

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

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?

Tell your doctor or pharmacist as soon as possible if you do not feel well while taking IBUPANE tablets.

This medicine helps most people with relief of pain, but it may have unwanted side effects in a few people.

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 in OTC medicines.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

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

Less serious side effects

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

Less serious side effectsWhat to do
  • Nausea
  • Vomiting
  • Stomach pain
  • Loss of appetite
  • Diarrhoea
  • Heartburn, indigestion
  • Dizziness
  • Light-headedness
  • Drowsiness
  • Headache
  • Nervousness
  • Sweating
Speak to your doctor or pharmacist if you have any of these less serious side effects and they worry you.

Serious / rare side effects

This 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.

Serious side effectsWhat to do
  • 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
  • If you get sunburnt more quickly than usual.
Tell your doctor as soon as possible.

Very serious side effects

This list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare for low doses of this medicine and when used for a short period of time.

Serious side effectsWhat to do
  • Fluid retention
  • 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
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these very 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.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

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

What IBUPANE contains

Active ingredient
(main ingredient)
Each IBUPANE tablet contains:
  • Paracetamol 500 mg
  • Ibuprofen 200 mg
Other ingredients
(inactive ingredients)
  • Pregelatinised maize starch
  • Povidone
  • Crospovidone
  • Microcrystalline cellulose
  • Colloidal anhydrous silica
  • Magnesium stearate
  • Hypromellose
  • Purified talc
  • Titanium dioxide
  • OPADRY fx special effects film coating system 63F97546 SILVER (ARTG PI No: 106945)

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

What IBUPANE looks like

IBUPANE is white to off white, oval shaped biconvex, film-coated pearlescent tablet plain on both sides (AUST R 267396).

It is available in packs of 12 and 24 tablets.

Who distributes IBUPANE

Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.viatris.com.au
Phone: 1800 274 276

This leaflet was prepared in September 2023.

IBUPANE® is a Viatris company trade mark

IBUPANE_cmi\Sep23/00

Published by MIMS October 2023

BRAND INFORMATION

Brand name

Ibupane

Active ingredient

Paracetamol; Ibuprofen

Schedule

S3 | S2

 

1 Name of Medicine

Paracetamol and ibuprofen.

2 Qualitative and Quantitative Composition

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

3 Pharmaceutical Form

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 years of age and children over 12 years.

Take 1 tablet three times a day when necessary (every 8 hours).
Keep to the recommended dose. Ibupane should not be used for more than 3 days at a time (or not more than 2 days at a time 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.

Elderly.

Do not give to adults aged 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

This product is contraindicated in patients with:
Known hypersensitivity or idiosyncratic reaction to ibuprofen, paracetamol, or any other ingredients in the medicinal product.
History of hypersensitivity reactions (e.g. bronchospasm, angioedema, rhinitis or urticaria) associated with aspirin or other NSAIDs or analgesic drugs.
Asthma.
Pregnancy (see Section 4.6 Fertility, Pregnancy and Lactation).
History of, or an existing gastrointestinal ulceration/ perforation or bleed, or other stomach disorder.
Impaired hepatic function, impaired renal function or heart failure.
Conditions that predispose to renal failure.
Taking other products containing ibuprofen or other NSAID-containing products including cyclooxygenase-2 (COX-2) specific inhibitors and aspirin or other anti-inflammatory medicines as there is an increased risk of adverse reactions.
Taking other paracetamol-containing products 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.
Aged 65 years and over and in children under 12 years.
Undergoing treatment of perioperative pain in setting of coronary artery bypass surgery (CABG).
See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions for additional information.

4.4 Special Warnings and Precautions for Use

The hazard of paracetamol overdose is greater in patients with non-cirrhotic alcoholic 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. This product is contraindicated in patients with asthma (see Section 4.3 Contraindications).

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.

As with other NSAIDs, excessive or prolonged use of ibuprofen may increase the risk of serious cardiovascular events, including myocardial infarction and stroke. Patients with cardiovascular disease, history of atherosclerotic cardiovascular disease or cardiovascular risk factors may also be at greater risk.
Appropriate monitoring and advice are required for patients with a history of hypertension as fluid retention and oedema have been reported in associated with NSAID therapy. Patients taking antihypertensives with NSAIDs may have an impaired antihypertensive response. The product is contraindicated in patients with heart failure (see Section 4.3 Contraindications).
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.
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. hypertension, 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 is 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.

Dermatological 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) has been reported in relation to 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 Ibupane tablets 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.

As with other drugs of this class, ibuprofen can mask the 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 Ibupane tablet is administered for fever or pain relief in relation to infection, monitoring the infection is advised. In non-hospital settings, the patient should consult a doctor if symptoms persist or worsen.
Ibupane tablets should not be taken with other products containing ibuprofen, paracetamol, aspirin, salicylates or with any other anti-inflammatory medicines unless under a doctor's instruction.

Use in the elderly.

Ibuprofen is contraindicated in adults aged 65 years and over because of an increased risk of adverse effects, in particular heart failure, gastro-intestinal ulceration and renal impairment.
The elderly is also more likely to have age related renal impairment.

Paediatric use.

The product is contraindicated in children under 12 years of age since no investigations have been carried out with this product in this age group.

Effects on laboratory tests.

No data available.
See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions for additional information.

4.5 Interactions with Other Medicines and Other Forms of Interactions

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

Chloramphenicol.

Increased plasma concentration of chloramphenicol.

Colestyramine.

The speed of absorption of paracetamol is reduced by colestyramine. Therefore colestyramine should not be taken within 1 hour if maximal analgesia is required.

Flucloxacillin.

Concurrent use of paracetamol and with flucloxacillin is associated with an increased risk of metabolic acidosis especially in patients with severe renal impairment, sepsis, malnutrition and chronic alcoholism.

Isoniazid.

May increase paracetamol toxicity.

Liver enzyme-inducing drugs.

Drugs which induce or regulate liver microsomal enzymes (cytochrome p-450 isoenzyme 2E1), such as anticonvulsants (including phenytoin, barbiturates, carbamazepine) and alcohol, may increase the hepatoxic potential of paracetamol.
Paracetamol absorption is increased by drugs which increase gastric emptying, e.g. metoclopramide and domperidone, and decreased by drugs which decrease gastric emptying, e.g. propantheline, antidepressants with anticholinergic properties and narcotic analgesics.
Paracetamol excretion may be affected and plasma concentrations altered when given with probenecid.

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. Dosage may require reduction if this medication and anticoagulants are taken for a prolonged period of time.
This product (like any other ibuprofen containing products and NSAIDs) should be used with caution in combination with:

Anticoagulants.

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

Antihypertensives.

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

Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs).

Increased risk of gastrointestinal bleeding.

Cardiac glycosides.

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

Ciclosporin.

Increased risk of nephrotoxicity.

Corticosteroids.

An increased risk of gastrointestinal ulceration or bleeding.

Diuretics.

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

Lithium.

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

Methotrexate.

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

Aspirin and other NSAIDs.

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

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 increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.

Zidovudine.

Increased risk of heamatological toxicity when NSAIDs are given concomitantly with zidovudine. There is evidence of an increased risk of haemarthroses 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)
NSAIDs inhibit prostaglandin synthesis and, when given during the latter part of pregnancy, may cause closure of the foetal ductus arteriosus, foetal renal impairment, inhibition of platelet aggregation, and delay labour and birth.
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.
Further, there is insufficient experience with the safety 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.
Paracetamol appears in breast milk but not in a clinically significant amount. Available published data do not contraindicate breastfeeding. Maternal ingestion of paracetamol in recommended doses does not appear to present a risk to breastfed infants. Ibuprofen and its metabolites can appear in breast milk in very low concentrations and is unlikely to affect the breast fed infant adversely.

4.7 Effects on Ability to Drive and Use Machines

Patients experiencing dizziness or drowsiness while taking Ibupane tablets should refrain from driving a vehicle or operating machines.

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%).

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 (AGEP).

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.

Immune system disorders.

Hypersensitivity with urticaria and pruritus.

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 non-specific 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).

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 (cannot be estimated from the available data).

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:
Non-specific allergic reactions and anaphylaxis.
Respiratory tract reactivity e.g. asthma, aggravated asthma, bronchospasm and dyspnoea.
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

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

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.
Symptoms. Symptoms of paracetamol overdose in the first 24 hours include pallor, nausea, vomiting, anorexia and abdominal pain.
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.
In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema and death. 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. CNS stimulation and delirium may occur initially, followed by CNS depression, stupor, hypothermia, rapid shallow breathing, hypotension and circulatory failure. Shock may also develop, as well as seizures and coma. Cardiac arrhythmias and pancreatitis have been reported.

Additional information on special patient populations.

An increased risk of liver damage from paracetamol overdosing has been associated with: Patients taking isoniazid.
Management. 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.

Ibuprofen.

Symptoms.

Most patients who have ingested clinically important amounts of NSAIDs will develop no more than nausea, vomiting, epigastric pain, or more rarely 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.

Management.

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.

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 non-steroidal anti-inflammatory drugs (NSAIDs). Its mechanism of action is unknown, but is thought to be through peripheral inhibition of cyclooxygenases and subsequent prostaglandin synthetase inhibition.

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, titanium dioxide and Opadry fx special effects film coating system 63F97546 Silver (ARTG PI No: 106945).

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine. See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

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.

Australian register of therapeutic goods (ARTG).

AUST R 267396 - Ibupane paracetamol 500 mg and ibuprofen 200 mg film coated tablet blister.

6.6 Special Precautions for Disposal

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

6.7 Physicochemical Properties

Chemical structure.

Paracetamol.


Chemical name: N-(4-Hydroxyphenyl) acetamide.
Molecular Formula: C8H9NO2.
Molecular weight: 151.2.
Paracetamol is a white or almost white crystalline powder. It is sparingly soluble in water, freely soluble in alcohol, very slightly soluble in methylene chloride. Paracetamol is an analgesic and antipyretic.

Ibuprofen.


Chemical name: 2-(4-Isobutylphenyl) propionic acid.
Molecular Formula: C13H18O2.
Molecular weight: 206.3.
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.

CAS number.

Paracetamol: 103-90-2.
Ibuprofen: 15687-27-1.

7 Medicine Schedule (Poisons Standard)

S3 (Pharmacist Only Medicine): 16, 20, 24 and 30 tablet pack sizes.
S2 (Pharmacy Medicine): 4, 5, 6, 8, 10 and 12 tablet pack sizes.

Summary Table of Changes