Consumer medicine information

Advil 12Hour Extended Release Tablet

Ibuprofen

BRAND INFORMATION

Brand name

Advil 12 Hour Extended Release Tablets

Active ingredient

Ibuprofen

Schedule

What is in this leaflet

This leaflet answers some common questions about Advil 12Hour Extended Release Tablet (referred as Advil 12Hour). It does not contain all the available information. It does not take the place of talking to your pharmacist or doctor.

All medicines have benefits and risks. Your pharmacist or doctor will have weighed the risks of you taking Advil 12Hour against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, talk to your pharmacist or doctor

Keep this leaflet with your medicine. You may need to read it again.

What Advil 12Hour is used for

Advil 12Hour is used for the temporary relief of persistent pain likely to last for more than 6 hours associated with:

body pain
back pain
neck and shoulder pain
muscle pain
sprains and strains
osteoarthritis
arthritic, joint and rheumatic conditions
period pain
dental pain
sinus pain
cold and flu

Who should use Advil 12Hour

Advil 12Hour is recommended for adults and children 12 years of age and over.

How Advil 12Hour works

Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Ibuprofen, like all non-steroidal anti-inflammatory drugs, is an analgesic, antipyretic, and anti-inflammatory medication. There is strong evidence to support the view that the main mechanism of action of ibuprofen (like other NSAIDs) is related to decreasing formation of prostaglandins. Prostaglandins are naturally-occurring fatty acid derivatives that are widely distributed in the tissues. They are believed to be a common factor in the production of pain, fever, and inflammation.

Ask your pharmacist or doctor if you have any questions about this medicine. Your pharmacist or doctor may have given it for another reason.

This medicine is not addictive.

It is only available from your pharmacist.

Before you take Advil 12Hour

When you must not take it

Do not take Advil 12Hour if you are allergic to:

any medicines containing ibuprofen, aspirin or other NSAIDs.
any of the ingredients in Advil 12Hour listed at the end of this leaflet.

Some of the signs and 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

Do not take Advil 12Hour if you have/are:

asthma that is sensitive to aspirin or NSAIDs
a current or a past history of stomach bleeding or ulceration

Talk to your pharmacist or doctor about taking this medicine if you are over 65 years of age.

Taking this medicine may increase the risk of you getting stomach, heart or kidney problems.

signs of gastrointestinal bleeding, such as vomiting blood, bleeding from the back passage (rectum), or have black or bloody stools
heart failure
kidney disease
severe liver impairment
have recently had coronary artery bypass surgery (CABG).

Do not take Advil 12Hour if you are pregnant or trying to become pregnant.

Do not take Advil 12Hour if the expiry date (EXP.) printed on the pack has passed or if the packaging shows signs of tampering or the tablets do not look quite right.

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

Before you start to take it

Tell your pharmacist or doctor if you:

are allergic to any other medicines, foods, dyes or preservatives.
you have asthma
you have a stomach or duodenal ulcer
you have liver or kidney disease
you have cardiac impairment or high blood pressure
if you are taking any products containing aspirin or salicylates
you are taking other medications
you are under the care of a doctor for any serious condition

Ask your pharmacist or doctor about taking the medicine if you are breastfeeding. Very small amounts of ibuprofen pass into the breast milk. Your pharmacist or doctor will discuss the potential benefits and risks of taking the medicine if you are breastfeeding.

Taking other medicines

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

Some medicines and ibuprofen may interfere with each other. These include:

aspirin, salicylates and other non-steroidal anti-inflammatory drugs (NSAIDs)
warfarin or any other 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. Taking together with ibuprofen may increase the risk of gastrointestinal bleeding.
zidovudine, a medicine used to treat HIV infection
probenecid, medicines used to treat diabetes and phenytoin
SSRIs (selective serotonine reuptake inhibitors) taken together with ibuprofen may increase the risk of gastrointestinal bleeding

Tell a pharmacist or doctor if you are taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin.

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

If you have not told your pharmacist or doctor about any of the above, tell him/her before you start taking Advil 12Hour

How to take Advil 12Hour

Follow all directions given to you by your pharmacist or doctor carefully. They may differ from the information contained in this leaflet.

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

How to take Advil 12Hour

Adults and children 12 years and over:
Take 1 tablet every 12 hours while symptoms persist. Swallow the tablet whole with water - do not crush, chew, split or dissolve.

Do not take more than 1 tablet at a time.

Do not exceed 2 tablets in 24 hours.

Do not give this product to children under 12 years.

How long to take Advil 12Hour for:

Advil 12Hour should not be used for more than a few days at a time except on medical advice. If pain gets worse or last for more than a few days stop use and ask your pharmacist or your doctor.

If the pain usually lasts less than 6 hours or pain is expected to last less than 6 hours, Advil 12Hour should not be used. It is recommended to use regular Advil Tablets or Liquid Capsules.

Advil 12Hour is a bi-layer tablet. The first layer dissolves quickly to relieve pain fast. The second layer is sustained-release to give relief of persistent pain for up to 12 hours.

If Advil 12Hour does not relieve your symptoms, do not take extra tablets or any other products containing ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs). Tell your pharmacist or your doctor.

Excessive or prolonged use can be harmful and may increase the risk of heart attack, stroke or liver damage.

If you take too much Advil 12Hour (overdose)

Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26, Australia or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have taken too much Advil 12Hour. Do this even if there are no signs of discomfort or poisoning.

While you are taking Advil 12Hour

Things you must do

If you become pregnant while taking Advil 12Hour, tell your doctor immediately and stop using this product.

Tell all doctors, dentists and pharmacists who are treating you that you are taking Advil 12Hour.

Ask your doctor or pharmacist before you start taking any new medicines.

If you are going to have surgery tell your doctor you are taking Advil 12Hour

If you are going to have any laboratory tests, tell your doctor that you are taking Advil 12Hour. Advil 12Hour can affect the results of some of these tests.

Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed. Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.

Tell your doctor if you feel the tablets are not helping your condition.

Things to be careful of

Be careful driving or operating machinery until you know how Advil 12Hour affects you. This medicine may cause dizziness in some people. If this happens, do not drive or operate heavy machinery.

Side effects

Tell your pharmacist or doctor as soon as possible if you do not feel well while you are taking Advil 12Hour

All medicines can have side effects.

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

Tell your doctor if you notice any of the following and they worry you. Although most people will not experience any side effects, some of the side effects that may occur with Advil 12Hour are:

heartburn, nausea or stomach pain
vomiting
constipation
abdominal pain
bloating
loss of appetite
diarrhoea
abnormal vision
headache
fatigue
dizziness
nervousness
ringing or buzzing in the ears
skin blisters

Side effects may be minimized by using the smallest dose for the shortest duration of time.

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

get sunburnt more quickly than usual

If any of the following happen, stop use and tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

fluid retention
vomiting blood, bleeding from the back passage, or bloody or black stools
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
an allergic reaction including skin reddening, rash, blisters, itching, or hives on the skin

The above list includes serious and 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.

Tell your pharmacist or doctor if you notice anything that is making you feel unwell even if is not in this list.

Other side effects not listed above may also occur in some patients.

After taking Advil 12Hour

Storage

Keep Advil 12Hour where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

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

Keep your tablets in a cool dry place where the temperature stays below 25C.

Do not store Advil 12Hour or any other medicine in the bathroom or near a sink.

Do not leave Advil 12Hour in the car or on window sills. Heat and dampness can destroy some medicines.

Disposal

If your pharmacist or doctor tells you to stop taking Advil 12Hour, or your tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.

Product description

What Advil 12Hour looks like

Advil 12Hour is a white, film-coated, capsule-shaped tablet printed in blue ink on one side.

Pack sizes of 1 (professional sample), 8, 12, 14, 16, 24, 25, 28 and 32 tablets. Not all presentations may be marketed.

Ingredients

Each Advil 12Hour tablet contains ibuprofen 600 mg, 200 mg immediate release, and 400 mg extended release.

The tablet also contains the following inactive ingredients:

carnauba wax
colloidal anhydrous silica
maize satrch
croscarmellose sodium
hypromellose
microcrystalline cellulose
polydextrose
macrogol 400
pregelatinised maize starch
sodium lauryl sulfate
stearic acid
titanium dioxide
pharmaceutical ink (Opacode WB Blue NS-78-10521)

Sponsor

GlaxoSmithKline Consumer Australia Pty Limited
82 Hughes Avenue Ermington NSW 2115
Australia Toll Free Phone Number
1800 028 533
Web: www.advil.net.au

Australian registration number:

Advil 12Hour
AUST R 306571

This leaflet was prepared on Sep 2020.

® Registered trademark

Published by MIMS November 2020

BRAND INFORMATION

Brand name

Advil 12 Hour Extended Release Tablets

Active ingredient

Ibuprofen

Schedule

1 Name of Medicine

Each Advil 12 Hour Extended Release Tablet (referred as Advil 12 Hour) contains 600 mg ibuprofen.
The first layer consists of 200 mg ibuprofen immediate release and the second layer, 400 mg ibuprofen extended release.

2 Qualitative and Quantitative Composition

Advil 12 Hour is a bi-layer tablet which contains 600 mg ibuprofen.
The first layer consists of 200 mg ibuprofen immediate release and the second layer, 400 mg ibuprofen extended release.
Also contains sulfites, soya beans and soya bean products.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Advil 12 Hour is a white, film-coated, capsule-shaped tablet printed in blue ink on one side.

4 Clinical Particulars

4.1 Therapeutic Indications

Advil 12 Hour is indicated for use as follows:
Temporary relief of persistent pain likely to last for more than 6 hours associated with: body pain, back pain, neck and shoulder pain, muscle pain, sprains and strains, osteoarthritis, arthritic, joint and rheumatic conditions, period pain, dental pain, sinus pain, cold and flu.

4.2 Dose and Method of Administration

Adults and children 12 years and over.

Take 1 tablet every 12 hours while symptoms persist. Swallow tablet whole with water - do not crush, chew, split or dissolve.
Do not take more than 1 tablet at a time.
Do not exceed 2 tablets in 24 hours.
Do not give this product to children under 12 years of age.
Advil 12 Hour should not be used for more than a few days at a time unless on medical advice, in which case the patient should be reviewed regularly with regards to efficacy, risk factors and ongoing need for treatment.
Patient should be advised to stop use of this medicine and consult a doctor if pain worsens or lasts for more than a few days.
If the pain usually lasts less than 6 hours or pain is expected to last less than 6 hours, Advil 12 Hour should not be used. It is recommended to use regular Advil tablets or Advil liquid capsules.

4.3 Contraindications

Advil 12 Hour is contraindicated for use in:
Patients with known hypersensitivity or idiosyncratic reaction to ibuprofen (or any of the other ingredients in the product).
Patients with known hypersensitivity to aspirin and other NSAIDs.
Patients with asthma that is aspirin or NSAID sensitive.
Patients with active or previous history of gastrointestinal bleeding or ulceration.
Pregnant women or women who are trying to become pregnant (see Section 4.6 Fertility, Pregnancy and Lactation, Use in pregnancy).
Patients with renal impairment.
Patients with heart failure.
Patients with severe liver impairment.
Patients undergoing treatment of perioperative pain in setting of coronary artery bypass surgery (CABG).
Advil 12 Hour should not be taken with other products containing ibuprofen or with other anti-inflammatory medicines.
See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions for additional information.

4.4 Special Warnings and Precautions for Use

Advil 12 Hour should be used with caution in:
Patients with asthma.
Patients with cardiac impairment or hypertension (see Section 4.4 Special Warnings and Precautions for Use, Cardiovascular and cerebrovascular effects).
Patients with hepatic impairment (see Section 4.4 Special Warnings and Precautions for Use, Use in hepatic impairment).
Patients taking other products containing aspirin and salicylates.
Ibuprofen may cause severe allergic reactions including skin reddening, rash, or blisters. Patients should be advised to stop use and immediately contact a doctor if these symptoms are observed.
Ibuprofen may cause a patient to vomit blood or have bloody or black stools. Patients should be advised to stop use and contact a doctor immediately if these symptoms are observed.
Side effects may be minimised by using this medicine for the shortest duration necessary to control symptoms.
Excessive or prolonged use can be harmful and increase the risk of heart attack, stroke or liver damage.
Use with caution in the elderly (see Use in the elderly).
See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions for additional information.

Identified precautions.

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.
Advil 12 Hour should be used with caution in patients with hypertension (also see Section 4.3 Contraindications, heart failure).

Use in hepatic impairment.

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).

Use in renal impairment.

No data available.

Use in the elderly.

Ibuprofen should not be taken by adults over the age of 65 without careful consideration of co-morbidities and co-medications because of an increased risk of adverse effects, in particular heart failure, gastro-intestinal ulceration and renal impairment (also see Section 4.3 Contraindications, renal impairment, heart failure).

Paediatric use.

Advil 12 Hour is not indicated for children < 12 years of age.

Effects on laboratory tests.

See Section 4.8 Adverse Effects (Undesirable Effects).

4.5 Interactions with Other Medicines and Other Forms of Interactions

The following interactions with ibuprofen have been noted:
Other NSAIDs.
Anticoagulants, including warfarin - ibuprofen interferes with the stability of INR and may increase 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.
Ibuprofen may decrease renal clearance and increase plasma concentration of lithium.
Ibuprofen may reduce the anti-hypertensive effect of ACE inhibitors, beta-blockers and diuretics and may cause natriuresis and hyperkalaemia in patients under these treatments.
Ibuprofen reduces methotrexate clearance.
Ibuprofen may increase the plasma levels of cardiac glycosides.
Ibuprofen may increase the risk of gastrointestinal bleeding especially if taken with corticosteroids.
Ibuprofen may prolong bleeding time in patients treated with zidovudine.
Ibuprofen may also interact with probenecid, antidiabetic medicines and phenytoin.
Ibuprofen may decrease the benefit of aspirin taken for heart attack or stroke.
Ibuprofen may increase the risk of gastrointestinal bleeding if combined with selective serotonin reuptake inhibitors (SSRIs).

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(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.
Advil 12 Hour should not be used in pregnant women or women who are trying to become pregnant.
Ibuprofen inhibits prostaglandin synthesis and, when given during the latter part of a pregnancy, may cause closure of the fetal ductus arteriosus, fetal renal impairment, inhibition of platelet aggregation and may delay labour and birth.
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.
Ibuprofen appears 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

No data available.

4.8 Adverse Effects (Undesirable Effects)

The following adverse effects may be associated with the use of ibuprofen and are listed under their corresponding body system organ class.

Blood and lymphatic system disorders.

Agranulocytosis, anaemia, aplastic anaemia, haemolytic anaemia, leukopenia, thrombocytopenia.

Investigations.

Haematocrit decreased, haemoglobin decreased.

Eye disorders.

Visual disturbance.

Gastrointestinal disorders.

Dyspepsia, heartburn, nausea, loss of appetite, abdominal pain, abdominal pain upper, vomiting, haematemesis, abdominal distension, diarrhoea, Crohn's disease, colitis, constipation, flatulence, gastritis, gastrointestinal haemorrhage, gastrointestinal perforation, gastrointestinal ulcer, melena, mouth ulceration.

Nervous system disorders.

Dizziness, fatigue, headache, cerebrovascular accident.

Psychiatric disorders.

Nervousness.

Immune system disorders.

Hypersensitivity, anaphylactic reaction. Allergic reactions such as skin rash, itching, swelling of the face or breathing difficulties may occur, and these are usually transient and reversible on cessation of treatment.

Cardiac disorders.

Cardiac failure, myocardial infarction, angina pectoris. Fluid retention and in some cases oedema, these effects are rare at non-prescription doses.

Vascular disorders.

Hypertension.

Ear and labyrinth disorders.

Tinnitus, vertigo.

Hepatobiliary disorders.

Liver disorder, hepatic function abnormal, hepatitis, jaundice.

Infections and infestations.

Meningitis aseptic, meningitis.

Renal and urinary disorders.

Haematuria, interstitial nephritis, renal failure, nephrotic syndrome, proteinuria, renal papillary necrosis.

Respiratory, thoracic and mediastinal disorders.

Asthma, bronchospasm, dyspnoea, wheezing.

Skin and subcutaneous tissue disorders.

Angioneurotic oedema, dermatitis bullous, erythema multiforme, face oedema, rash, rash maculopapular, pruritus, purpura, Stevens-Johnson syndrome, urticaria. Rarely exfoliative dermatitis and toxic epidermal necrolysis have been reported with ibuprofen. Rare cases of photosensitivity.

General disorders and administration site conditions.

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

The following signs and symptoms may be associated with ibuprofen overdose:

Ear and labyrinth disorders.

Vertigo.

Gastrointestinal disorders.

Nausea, abdominal pain, vomiting.

Hepatobiliary disorders.

Hepatic function abnormal.

Metabolism and nutrition disorders.

Hyperkalaemia, metabolic acidosis.

Nervous system disorders.

Dizziness, somnolence, headache, loss of consciousness, convulsion.

Renal and urinary disorders.

Renal failure.

Respiratory, thoracic and mediastinal disorders.

Dyspnoea, respiratory depression.

Vascular disorders.

Hypotension.
In case of overdose, immediately contact the Poisons Information Centre (in Australia, call 13 11 26; in New Zealand call 0800 764 766) for advice.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

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.

Clinical efficacy studies show that Advil 12 Hour provides rapid onset of analgesia which is maintained for at least 12 hours after dosing in a model of dental pain, and that this efficacy is sustained over multiple doses.
The 2 studies, AK-09-07 (single dose) and AK-10-13 (multiple dose), providing efficacy information for Advil 12 Hour were conducted using the post-surgical dental pain model. In this model, patients are recruited to receive study drug following surgical extraction of impacted third molars. In Study AK-10-13, subjects were to have had removal of at least 2 third molars, and in Study AK-09-07, subjects were to have had removal of 1 or 2 third molars. In both studies, at least 1 of the extracted molars was to have been a partial or full bony mandibular impaction.
The post-surgical dental pain model is widely used in post-operative analgesia studies. Results obtained with this model have been shown to compare favourably with those from other pain models (such as general surgery, obstetrics-gynecology surgery, and bunionectomy), and hence support the applicability of results using the post-surgical dental pain model across other pain states. The intensity of pain following dental surgery (third molar extraction) is consistent and well characterised, giving the model proven sensitivity for distinguishing analgesic efficacy over this time interval. In addition, the pain lasts for several days and, although limited, the available data from multiple-dose dental pain studies suggest that the model is adequately sensitive to separate active treatments from placebo on the second post-surgical day. These characteristics make the dental pain model suitable to evaluate both single and multiple-dose efficacy (up to 48 hours) of Advil 12 Hour compared with placebo.
The efficacy results of studies AK-09-07 and AK-10-13 were consistent and the combined dataset showed a significantly favorable treatment benefit for Advil 12 Hour compared with placebo for all of the efficacy endpoints analysed (p ≤ 0.05).
The individual study and combined data showed that Advil 12 Hour provided significantly better efficacy compared to placebo throughout a 12-hour dosing interval, with higher mean Sum of Pain Relief and Pain Intensity Difference Scores (SPRID) at all time points (0-12, 0-4, 4-8 and 8-12 hours) and a smaller proportion of subjects using rescue medication by 4, 8 and 12 hours (p ≤ 0.05).
The median time to first use of rescue medication (i.e. duration of relief) was significantly longer (p ≤ 0.05) for the Advil 12 Hour treatment group (> 12 hours) compared with the placebo group (< 2 hours).
The median times to onset of First Perceptible Relief Confirmed by Meaningful Relief (FPRC) and Meaningful Relief (MR) were significantly shorter (p ≤ 0.05) for the Advil 12 Hour treatment group (approximately 0.5 hours and 1.0 hour respectively) compared with the placebo group (> 6 hours for both endpoints).
Pooled data up to 12 hours from the 2 efficacy studies demonstrate that significant analgesic efficacy of Advil 12 Hour was achieved compared to placebo, for all endpoints analysed, at all-time points through 12 hours following the first dose, and in all subgroups analysed. The key end points are shown in Table 1.

Taken together with the pharmacokinetic data demonstrating the bioequivalence of Advil 12 Hour to 3 x 200 mg ibuprofen immediate release tablets, these efficacy data support the dosing recommendation of one Advil 12 Hour tablet every 12 hours (with a maximum daily dose of two tablets or 1200 mg) for the relief of pain lasting for more than 6 hours.

5.2 Pharmacokinetic Properties

Ibuprofen is well absorbed from the gastrointestinal tract. It is highly bound (90-99%) to plasma proteins and is extensively metabolised to inactive compounds in the liver, mainly by glucuronidation. 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.
Pharmacokinetic (PK) study (AK-10-10) was conducted to determine the rate and extent of absorption of ibuprofen in normal healthy subjects from a single dose of Advil 12 Hour administered under fasted conditions compared to 3 single doses of ibuprofen 200 mg immediate release (IR) tablets (administered every 4 hours; first dose in the fasted state). This study also evaluated the PK profile of Advil 12 Hour in the fed state (following a high fat meal). The PK results obtained demonstrate that the rate (C_max) and overall extent (AUC) of absorption of ibuprofen from Advil 12 Hour in the fasted state were bioequivalent to ibuprofen 200 mg IR tablets administered every 4 hours. The results also indicated that the overall extent (AUC) of ibuprofen absorption from the Advil 12 Hour was bioequivalent in the fed and fasted state, but the rate of absorption (C_max) was slower in the presence of food.
Pharmacokinetic study (AK-10-12) was a multiple dose PK study conducted in normal healthy subjects to compare the PK profile of Advil 12 Hour versus ibuprofen 200 mg immediate release tablets at steady state, i.e. after 4 days of dosing. The results of this study demonstrate that the rate and extent of ibuprofen absorption from Advil 12 Hour is bioequivalent to ibuprofen 200 mg immediate tablets after multiple doses of both formulations, i.e. there is no drug accumulation with multiple doses of Advil 12 Hour.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Advil 12 Hour also contains the following inactive ingredients: carnauba wax, colloidal anhydrous silica, maize starch, croscarmellose sodium, hypromellose, microcrystalline cellulose, polydextrose, macrogol 400, pregelatinised maize starch, sodium lauryl sulfate, stearic acid, titanium dioxide, pharmaceutical ink (Opacode WB Blue NS-78-10521).

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.
Keep out of reach of children.

6.5 Nature and Contents of Container

Advil 12 Hour tablets are packaged in a unit dose blister system.

Pack sizes.

1 tablet (professional sample); 8 tablets; 12 tablets; 14 tablets; 16 tablets; 24 tablets; 25 tablets; 28 tablets; 32 tablets.
Not all presentations 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.

Ibuprofen is chemically known as (2RS)-2-[4-(2-Methylpropyl) phenyl] propanoic acid and has the following structure:

Ibuprofen is a white or almost white, crystalline powder or colourless crystals.

CAS number.

15687-27-1.

7 Medicine Schedule (Poisons Standard)

Pharmacist Only Medicine (Schedule 3).

Log in

Consumer medicine information

Advil 12Hour Extended Release Tablet

Ibuprofen

Keep track of your medicines

BRAND INFORMATION