Consumer medicine information

Nurofen 12 Hour

Ibuprofen

BRAND INFORMATION

Brand name

Nurofen 12 Hour

Active ingredient

Ibuprofen

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Nurofen 12 Hour.

FULL CMI

Nurofen® 12 Hour

Active ingredient(s): Ibuprofen 300mg

Consumer Medicine Information (CMI)

This leaflet provides important information about using Nurofen 12 Hour. 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 Nurofen 12 Hour.

Where to find information in this leaflet:

1. Why am I using Nurofen 12 Hour?
2. What should I know before I use Nurofen 12 Hour?
3. What if I am taking other medicines?
4. How do I use Nurofen 12 Hour?
5. What should I know while using Nurofen 12 Hour?
6. Are there any side effects?
7. Product details

1. Why am I using Nurofen 12 Hour?

Nurofen 12 Hour contains the active ingredient Ibuprofen. Nurofen 12 Hour is a Pharmacist only medicine. Ibuprofen belongs to a group of non-steroidal anti-inflammatory drugs (NSAID) medications that have pain relieving and fever relieving properties. Nurofen 12 Hour is made to release its ingredient slowly over 12 hours so you need to take less doses than standard tablets.

Nurofen 12 Hour is used for the temporary relief of pain and inflammation associated with: headache, migraine headache, tension headache, sinus pain, toothache, dental procedures, back pain, muscular aches and pains, arthritis, osteoarthritis, rheumatic pain, period pain, fibrositis, neuralgia, sore throat, tennis elbow, cold and flu symptoms. It also reduces fever.

2. What should I know before I use Nurofen 12 Hour?

Warnings

Do not use Nurofen 12 Hour if:

  • you are allergic to any medicines containing Ibuprofen, aspirin or other NSAIDS or any of the ingredients listed at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
Some of the symptoms of an allergic reaction may include:
- shortness of breath;
- wheezing or difficulty breathing;
- swelling of the face, lips, tongue or other parts of the body; and
- rash, itching or hives on the skin.
  • you have any of the following conditions:
    - liver or kidney disease;
    - heart problems;
    - asthma that is sensitive to aspirin or NSAIDs;
    - 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 are taking more than 75mg of aspirin a day.
If you are on low-dose (up to 75mg daily) speak to your pharmacist before taking this medicine.
  • in the last three months of pregnancy. It may affect the baby and also delay labour and birth.
  • for children under 12 years of age.
  • After the expiry date printed on the pack or if the package is torn or shows signs of tampering. If this medicine has expired or is damaged, return it to your pharmacist for disposal.

Check with your doctor or pharmacist if you:

  • have or have had any other medical conditions
    - asthma;
    - stomach or duodenal ulcer;
    - signs of gastrointestinal bleeding, such as vomiting blood or bleeding from the back passage (rectum);
    - liver or kidney disease;
    - heart problems.
  • take any medicines for any other condition
  • if you are over 65 years of age.
Taking this medicine may increase the risk of you getting stomach, heart or kidney problems.
  • have allergies to any other medicines, foods, preservatives or dyes.
  • are not sure whether you should start taking Nurofen 12 Hour

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

Check with your doctor or pharmacist if you are pregnant or intend to become pregnant.

Nurofen 12 Hour may affect your developing baby. Your pharmacist or doctor will discuss the benefits and possible risks of taking it during pregnancy.

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

This medicine may be taken by breastfeeding mothers; however small amounts of ibuprofen pass into the breast milk.

3. What if I am taking other medicines?

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

Some medicines may interfere with Nurofen 12 Hour and affect how it works.

  • warfarin, a medicine used to prevent blood clots;
  • lithium, a medicine used to treat mood swings and some types of depression;
  • medicines used to lower blood pressure;
  • methotrexate, a medicine used to treat arthritis and some types of cancer;
  • medicines used to treat heart failure;
  • medicines such as prednisone, prednisolone and cortisone, which reduce the activity of your immune system;
  • zidovudine, a medicine used to treat HIV infection;
  • aspirin, salicylate and other non-steroidal anti-inflammatory drugs (NSAIDs); and
  • medicines used to treat diabetes.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Nurofen 12 Hour.

4. How do I use Nurofen 12 Hour?

How much to take / use

  • Initial dose, 600mg (2 x 300mg tablets). Then if necessary, another 600mg can be taken.
  • Leave at least 12 hours between doses and do not exceed 1200mg (4 x 300mg tablets) in 24 hours.
  • Follow the instructions provided with the medicine.
  • Do not exceed the recommended dosage.
  • If symptoms worsen, or persist consult a doctor.
  • Do not use this medicine in children under 12 years of age.

When to take / use Nurofen 12 Hour

  • Nurofen 12 Hour should be used at least 12 hours between doses and do not exceed 1200mg (4 x 300mg tablets) in 24 hours.

How to take Nurofen 12 Hour

  • Take Nurofen 12 Hour with water and swallow whole. Do not chew the tablets.
  • Do not take Nurofen 12 Hour for longer than 3 days at a time.

If you use too much Nurofen 12 Hour

If you think that you have used too much Nurofen 12 Hour, you may need urgent medical attention.

You should immediately:

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

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

5. What should I know while using Nurofen 12 Hour?

Things you should do

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

Your pharmacist or doctor will assess your condition and decide if you should continue to take the medicine.

Remind any doctor, dentist, or pharmacist you visit that you are using Nurofen 12 Hour.

Things you should not do

  • Do not take Nurofen 12 Hour to treat any other complaints unless your pharmacist or doctor tells you to.
  • Do not give your medicine to anyone else, even if they have the same symptoms as you.
  • Do not take more than the recommended dose unless your pharmacist or doctor tells you to.

Things to be careful of

  • If you are over the 65 years of age, talk to your pharmacist or doctor about taking Nurofen 12 Hour. Taking this medicine may increase the risk of you getting unwanted side 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 Nurofen 12 Hour affects you.

Drinking alcohol

Tell your doctor or pharmacist if you drink alcohol.

Looking after your medicine

  • Keep your medicine in the original pack until it is time to take it.

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

Store it in a cool dry place where the temperature stays below 25°C 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 windowsills.

Heat and dampness can destroy some medicines.

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?

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.

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

[Less serious/common] side effects

Less serious side effectsWhat to do
Gastrointestinal related:
  • nausea
  • heartburn, or stomach pain
  • loss of appetite
  • diarrhoea
Head and neurology related:
  • dizziness
  • drowsiness
  • headache or
  • nervousness
Speak to your doctor or pharmacist if you have any of these less serious side effects and they worry you.

[Serious/rare] side effects

Serious side effectsWhat to do
Cardiovascular related:
  • fluid retention.
Gastrointestinal related:
  • vomiting blood or bleeding from the back passage
Allergy related:
  • 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
  • get sunburnt more quickly than usual.
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

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

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

Reporting side effects

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

7. Product details

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

What Nurofen 12 Hour contains

Active ingredient
(main ingredient)		Ibuprofen 300mg
Other ingredients
(inactive ingredients)		Colloidal hydrated silica
Hypromellose
Silicified microcrystalline cellulose
Croscarmellose sodium
Glycine
Stearic Acid
Carnauba Wax
Opadry Yellow (consisting of hypromellose, quinoline yellow (E104), titanium dioxide, macrogol and polysorbate 80
Potential allergensN/A

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

What Nurofen 12 Hour looks like

Nurofen 12 Hour is a white to off-white capsule-shaped tablets debossed with "N12" on one side and plain on the other (AUST R 335682).

Nurofen 12 Hour is available in blister packs* of 6, 8, 10, 12, 16, 20 or 24 tablets.

*Not all pack sizes are marketed.

Who distributes Nurofen 12 Hour

Reckitt Benckiser, Sydney, NSW, Australia

This leaflet was prepared in April 2021.

Published by MIMS June 2021

BRAND INFORMATION

Brand name

Nurofen 12 Hour

Active ingredient

Ibuprofen

Schedule

S3

 

1 Name of Medicine

Ibuprofen.

2 Qualitative and Quantitative Composition

Nurofen 12 Hour modified release tablet contain 300 mg of ibuprofen.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Nurofen 12 Hour modified release tablet.White to off-white capsule-shaped tablets debossed with 'N12' on one side and plain on the other.

4 Clinical Particulars

4.1 Therapeutic Indications

For the temporary relief of persistent pain and/or inflammation likely to last more than 6 hours associated with: sinus pain, toothache, dental procedures, backache, muscular aches and pains, arthritis, osteoarthritis, rheumatic pain, period pain, fibrositis, neuralgia, sore throat, tennis elbow, and colds and flu.

4.2 Dose and Method of Administration

Posology.

The minimum effective dose should be used for the shortest time necessary to relieve symptoms.

Adults and children over 12 years.

Initial dose of 600 mg. Then, if necessary, another 600 mg can be taken. Leave at least 12 hours between doses. Do not take more than 1200 mg in 24 hours.
The patient should be advised to seek medical advice if symptoms persist or worsen, or if the product is required for more than a few days, in which case the patient should be reviewed regularly with regards to efficacy, risk factors and ongoing need for treatment.

Paediatric population.

This medicine should not be used by children or adolescents under the age of 12 years.

Pregnancy.

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

Method of administration.

For oral use and short time use only.
The tablets should be taken together with water and swallowed whole. Do not chew the tablets.
If pain usually lasts or is expected to last less than 6 hours, Nurofen 12 Hour should not be used. It is recommended to use regular ibuprofen tablets or capsules.

4.3 Contraindications

Nurofen 12 Hour should not be taken with other products containing ibuprofen or with other anti-inflammatory medicines.
Hypersensitivity to the active substance or to any of the excipients listed in Section 6.1.
Patients who have previously shown hypersensitivity reactions (e.g. rhinitis, angiodema or urticaria) in response to acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs).
Patients with asthma that is aspirin or NSAID sensitive.
Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding.
History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
Patients undergoing treatment of perioperative pain in setting of coronary artery bypass surgery (CABG).
Patients with severe hepatic failure, renal failure or heart failure (see Section 4.4 Special Warnings and Precautions for Use).
During the last trimester of pregnancy as there is a risk of premature closure of the foetal ductus arteriosus with possible persistent pulmonary hypertension. The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child (see Section 4.6 Fertility, Pregnancy and Lactation).
Children or adolescents under 12 years of age.

4.4 Special Warnings and Precautions for Use

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see Section 4.2 Dose and Method of Administration; see Gastrointestinal (GI), Cardiovascular and cerebrovascular effects).

Respiratory.

Bronchospasm may be precipitated in patients suffering from, or with a history of, bronchial asthma or allergic disease.

SLE and mixed connective tissue disease.

Systemic lupus erythematosus and mixed connective tissue disease - increased risk of aseptic meningitis (see Section 4.8 Adverse Effects (Undesirable Effects)).

Cardiovascular and cerebrovascular effects.

Caution (discussion with doctor or pharmacist) is required prior to starting treatment in patients with a history of hypertension and/or heart failure as fluid retention, hypertension and oedema have been reported in association with NSAID therapy.
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 (for example 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.

Impaired female fertility.

There is limited evidence that drugs which inhibit cyclo-oxygenase/ prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible upon withdrawal of treatment.

Gastrointestinal (GI).

NSAIDS should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see Section 4.8 Adverse Effects (Undesirable Effects)).
The elderly are at increased risk of the consequence of adverse reactions.
The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see Section 4.3 Contraindications), and in the elderly. These patients should commence treatment on the lowest dose available.
Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.
Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as corticosteroids, or anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as acetylsalicylic acid (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
When GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn.

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 DRESS) and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see Section 4.8 Adverse Effects (Undesirable Effects)). Patients appear to be at highest risk for 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. Nurofen 12 Hour should be discontinued at the first appearance of skin rash, mucosal lesions, or any other signs 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 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 Nurofen 12 Hour 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 lifethreatening. 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.

Use in hepatic impairment.

Nurofen 12 Hour should not be used in patients with hepatic impairment because hepatic function may further deteriorate (see Section 4.3 Contraindications; Section 4.8 Adverse Effects (Undesirable Effects)).

Use in renal impairment.

Nurofen 12 Hour should not be used in patients with renal impairment because renal function may further deteriorate (see Section 4.3 Contraindications; Section 4.8 Adverse Effects (Undesirable Effects)).

Masking of symptoms of underlying infections.

Nurofen 12 Hour 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 Nurofen 12 Hour is administered for fever or pain relief in relation infection, monitoring of infection is advised. In non-hospital settings the patient should consult a doctor if symptoms persist or worsen.

Use in the elderly.

The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal.

Paediatric use.

No data available.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Ibuprofen (like other NSAIDs) should be avoided in combination with:

Acetylsalicylic acid (aspirin).

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 suggest 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, and no clinically relevant effect is considered to be likely for occasional ibuprofen use (see Section 5.1 Pharmacodynamic Properties).

Other NSAIDS including cyclooxygenase-2 selective inhibitors.

Avoid concomitant use of two or more NSAIDS as this may increase the risk of adverse effects (see Section 4.4 Special Warnings and Precautions for Use).
Ibuprofen should be used with caution in combination with:

Anticoagulants.

NSAIDs may enhance the effects of anti-coagulants, such as warfarin (see Section 4.4 Special Warnings and Precautions for Use).

Antihypertensives and diuretics.

Since NSAIDs may diminish the effects of these drugs. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) the co-administration of an ACE inhibitor or Angiotensin II antagonist and agents that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible. These interactions should be considered in patients taking a coxib concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy, and periodically thereafter.
Diuretics can increase the risk of nephrotoxicity of NSAIDs.

Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs).

Increased risk of gastrointestinal bleeding (see Section 4.4 Special Warnings and Precautions for Use).

Cardiac glycosides.

NSAIDs may exacerbate cardiac failure, reduced GFR and increased plasma glycoside levels.

Ciclosporin.

Increased risk of nephrotoxicity.

Corticosteroids.

Increased risk of gastrointestinal ulceration or bleeding (see Section 4.4 Special Warnings and Precautions for Use).

Lithium.

There is evidence for potential increases in plasma levels of lithium.

Methotrexate.

There is evidence for the potential increase in plasma levels 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 an increased risk of developing convulsions.

Tacrolimus.

Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.

Zidovudine,

Increased risk of haematological toxicity when NSAIDs are given with zidovudine. There is evidence of an increased risk of haemarthroses and haematoma in HIV(+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.

Probenecid, antidiabetic medications and phenytoin.

Ibuprofen may interact with these medicines.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

There is some evidence that drugs which inhibit cyclo-oxygenase/ prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible on withdrawal of treatment.
(Category C)
Pregnancy Category C - Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.
The use of Nurofen 12 Hour should, if possible, be avoided during the first 6 months of pregnancy. Data from epidemiological studies suggest an increased risk of spontaneous abortion after use of prostaglandin synthesis inhibitors in early pregnancy. In animals, administration of prostaglandin synthesis inhibitors has been shown to result in increased pre- and post-implantation loss. Reproductive studies conducted in animals did not demonstrate evidence of developmental abnormalities. However, animal reproduction studies are not always predictive of human response. There are no adequate and well-controlled studies in pregnant women.
During the 3rd trimester, ibuprofen is contraindicated as there is a risk of premature closure of the foetal ductus arteriosus with possible persistent pulmonary hypertension. The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child (see Section 4.3 Contraindications).
See Section 4.4 regarding female fertility.
Consequently, Nurofen 12 Hour is contraindicated during the third trimester of pregnancy (see section 4.3 Contraindications).

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.
 In limited studies, ibuprofen appears in the breast milk in very low concentration and is unlikely to affect the breast-fed infant adversely.

4.7 Effects on Ability to Drive and Use Machines

Nurofen 12 Hour has no or negligible influence on the ability to drive and use machines at recommended doses and duration of therapy.

4.8 Adverse Effects (Undesirable Effects)

The frequencies of adverse effects are defined as follows:
Very common: ≥ 1/10; Common: ≥ 1/100 to < 1/10; Uncommon: ≥ 1/1,000 to < 1/100; Rare: ≥ 1/10,000 to < 1/1,000; Very Rare: < 1/10,000, including isolated reports. Not known: Cannot be estimated from the data available.

Blood and lymphatic system disorders.

Very rare: Haematopoietic disorders (anaemia, leucopenia, thrombocytopenia, pancytopenia and agranulocytosis).
No frequency information available: aplastic anemia and haemolytic anaemia.

Investigations.

Very rare: Haemoglobin decreased.
No frequency information available: Haematocrit decreased.

Eye disorders.

No frequency information available: Visual disturbance.

Gastrointestinal disorders.

Uncommon: Abdominal pain, nausea, dyspepsia.
Rare: Diarrhoea, flatulence, constipation and vomiting.
Very rare: Peptic ulcer, gastrointestinal perforation or gastrointestinal haemorrhage, melaena, haematemesis, ulcerative stomatitis, gastritis.
Not known: Exacerbation of ulcerative colitis and Crohn's disease.
No frequency information available: heartburn, loss of appetite, abdominal upper pain, abdominal distension.

Nervous system disorders.

Uncommon: Headache.
Very rare: Aseptic meningitis.
No frequency information available: Dizziness, fatigue, cerebrovascular accident.

Psychiatric disorders.

No frequency information available: Nervousness.

Immune system disorders.

Uncommon: Hypersensitivity reactions with urticaria and pruritus.
Very rare: severe hypersensitivity reactions, including facial, tongue and throat swelling, dyspnoea, tachycardia, hypotension, (anaphylaxis, angioedema or severe shock). Allergic reactions such as skin rash, itching, swelling of the face or breathing difficulties are usually transient and reversible on cessation of treatment.

Cardiac disorders.

Unknown: Cardiac failure, Fluid retention and oedema.
No frequency information not available: myocardial infarction, angina pectoris.

Vascular disorders.

Unknown: Hypertension.

Ear and labyrinth disorders.

Frequency information not available: Tinnitus, vertigo.

Hepatobiliary disorders.

Very rare: Liver disorder, hepatic function abnormal, hepatitis, jaundice.

Infections and infestations.

Very rare: Meningitis aseptic, meningitis.

Renal and urinary disorders.

Very rare: Acute renal failure, papillary necrosis, especially in long-term use, associated with increased serum urea and oedema.
Frequency information not available: Haematuria, interstitial nephritis, nephrotic syndrome and proteinuria.

Respiratory, thoracic and mediastinal disorders.

Not known: Respiratory tract reactivity comprising asthma, bronchospasm or dyspnoea.
Frequency information not available: wheezing.

Skin and subcutaneous tissue disorders.

Uncommon: Various skin rashes.
Very rare: Bullous reactions including Stevens Johnson Syndrome, erythema multiforme and toxic epidermal necrolysis, exfoliative dermatitis, maculopapular, purpura, uticaria, rash.
Unknown: Drug reaction with eosinophilia with systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), photosensitivity reactions.
Frequency information not available: Face oedema, rash maculopapular.

Pregnancy, puerperium and perinatal conditions.

Unknown: Oligohydramnios, neonatal renal impairment.

General disorders and administration site conditions.

Frequency information not available: Oedema, swelling, peripheral oedema.

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

In children, ingestion of more than 400 mg/kg may cause symptoms. In adults the dose response effect is less clear.

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 the prothrombin time/ INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur. Exacerbation of asthma is possible in asthmatics.

Treatment.

In case of overdose, immediately contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Pharmacotherapeutic group: Anti-inflammatory and anti-rheumatic products, non-steroids, propionic acid derivatives.
Ibuprofen is a propionic acid derivative NSAID that has demonstrated its efficacy by inhibition of prostaglandin synthesis. In humans, ibuprofen reduces inflammatory pain, swellings and fever. Furthermore, ibuprofen reversibly inhibits platelet aggregation.

Clinical trials.

In a multiple dose dental pain study a 600 mg dose of Nurofen 12 Hour modified release tablets was studied when dosed every 12 hours for 2 days. Nurofen 12 Hour modified release tablets were statistically significantly superior to placebo across all endpoints, at all time points from 30 minutes postdose for pain intensity difference (p < 0.05) and at all time points from 15 minutes for pain relief (p < 0.05). Early onset of efficacy was indicated by the shorter time to confirmed first perceptible relief after active (median time = 42 minutes) compared to placebo treatment (p < 0.0001) and shorter time to meaningful relief for active (median time = 108 minutes) compared to placebo treatment (p < 0.0001). Median time to first rescue medication was not achieved for active treatment over the first 12 hour dosage period.
The analgesic effects of a 2 tablet-dose (600 mg) of modified release ibuprofen last for up to 12 hours.

5.2 Pharmacokinetic Properties

Absorption.

Ibuprofen is well absorbed from the gastrointestinal tract. Ibuprofen is extensively bound to plasma proteins. Peak serum concentration occurs approximately 1-2 hours after administration for immediate-release ibuprofen. Nurofen 12 Hour is designed to mimic the early-release characteristics of immediate-release ibuprofen with modified release properties that maintain consistent release over a 12-hour dosing interval.
The pharmacokinetic profile of 600 mg of Nurofen 12 Hour, compared with that of three doses of 200 mg immediate-release tablets (4 hourly), showed that the modified release formulation achieved consistent release throughout the interval evaluated.
Compared with immediate-release tablets, the area under the plasma concentration-time curve (AUC) for modified release tablets was similar.

Metabolism.

Ibuprofen is metabolised in the liver to two major metabolites with primary excretion via the kidneys, either as such or as major conjugates, together with a negligible amount of unchanged ibuprofen.

Excretion.

Excretion by the kidney is both rapid and complete. Elimination half-life is approximately 2 hours.
No significant differences in pharmacokinetic profile are observed in the elderly.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Nurofen 12 Hour mg tablets: Silicon dioxide, hypromellose, silicified microcrystalline cellulose, croscarmellose sodium, glycine, stearic acid, opadry white (consisting of: hypromellose, titanium dioxide, macrogol and polysorbate 80), carnauba wax.
See Section 2 Qualitative and Quantitative Composition.

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

Do not store above 25°C.

6.5 Nature and Contents of Container

300 mg tablets.

Blister packs comprised of Alu/Alu enclosed in an outer carton containing 6, 8, 10, 12, 16, 20 or 24 tablets.
Not all pack sizes may be 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

Chemical structure.

The chemical structure of ibuprofen:

CAS number.

15687-27-1.

7 Medicine Schedule (Poisons Standard)

S3 - Pharmacist Only Medicine.

Summary Table of Changes