Consumer medicine information

Chemists’ Own Ibuprofen Double Strength 400

Ibuprofen

BRAND INFORMATION

Brand name

Chemists' Own Ibuprofen Double Strength 400

Active ingredient

Ibuprofen

Schedule

WHAT IS IN THIS LEAFLET

This leaflet answers some common questions about CHEMISTS’ OWN IBUPROFEN DOUBLE STRENGTH 400. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking CHEMISTS’ OWN IBUPROFEN DOUBLE STRENGTH 400 against the benefits they expect it will have for you.

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

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

WHAT CHEMISTS’ OWN IBUPROFEN DOUBLE STRENGTH 400 IS USED FOR

Ibuprofen relieves pain and reduces inflammation (swelling, redness or soreness) that may occur:

in different types of arthritis including rheumatoid arthritis, osteoarthritis and juvenile rheumatoid arthritis
in muscle and bone injuries such as sprains, strains, lower backpain (lumbago), rheumatism, and tendonitis, such as tennis elbow
from swelling and pain after setting broken or dislocated bones
menstrual cramps (period pain)
following surgery
due to dental pain

CHEMISTS’ OWN IBUPROFEN DOUBLE STRENGTH 400 also relieves fever (high temperature).

Although CHEMISTS’ OWN IBUPROFEN DOUBLE STRENGTH 400 can relieve the symptoms of pain and inflammation, it will not cure your condition.

CHEMISTS’ OWN IBUPROFEN DOUBLE STRENGTH 400 belongs to a group of medicines called non-steroidal anti-inflammatory drugs (or NSAIDs).

Ask your doctor if you have any questions about why CHEMISTS’ OWN IBUPROFEN DOUBLE STRENGTH 400 has been prescribed for you. Your doctor may have prescribed CHEMISTS’ OWN IBUPROFEN DOUBLE STRENGTH 400 for another reason.

This medicine is available only with a doctor's prescription.

BEFORE YOU TAKE CHEMISTS’ OWN IBUPROFEN DOUBLE STRENGTH 400

When you must not take it

Do not take CHEMISTS’ OWN IBUPROFEN DOUBLE STRENGTH 400 if you have an allergy to:

any medicines containing ibuprofen, aspirin or other NSAIDs;
any of the ingredients listed at the end of this leaflet;

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

Many medicines used to treat headache, period pain and other aches and pains contain aspirin or NSAID medicines. If you are not sure if you are taking any of these medicines, ask your doctor or pharmacist.

If you are allergic to aspirin or any other NSAID medicines and take CHEMISTS’ OWN IBUPROFEN DOUBLE STRENGTH 400, these symptoms may be severe.

Do not take CHEMISTS’ OWN IBUPROFEN DOUBLE STRENGTH 400 if:

you are pregnant or intend to become pregnant.

CHEMISTS’ OWN IBUPROFEN DOUBLE STRENGTH 400 may affect your baby if you take it during pregnancy.

you are breastfeeding or intend to breastfeed.

CHEMISTS’ OWN IBUPROFEN DOUBLE STRENGTH 400 passes into breastmilk and may affect you baby.

you have (or have recently) vomited blood or material that looks like coffee grounds
you are (or have previously) bleeding from the back passage (rectum), have black sticky bowel motions (stools) or bloody diarrhoea
you have a condition resulting in an increased tendency to bleed
you have a peptic ulcer (i.e. a stomach or duodenal ulcer) a recent history of one, or have had peptic ulcers before
you have, or have a history of, Ulcerative Colitis or Crogn’s Disease
you have severe heart failure
you have severe liver disease
you have severe kidney disease

Do not take CHEMISTS’ OWN IBUPROFEN DOUBLE STRENGTH 400 after the expiry date printed on the pack or if the package is torn or shows sign of tampering. If this medicine has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking CHEMISTS’ OWN IBUPROFEN DOUBLE STRENGTH 400, talk to your pharmacist or doctor.

Before you start to take it

Tell your pharmacist or doctor if:

you have allergies to:

any other substances such as medicines, foods, preservatives or dyes

you are pregnant or intend to become pregnant

Like most NSAID medicines, CHEMISTS’ OWN IBUPROFEN DOUBLE STRENGTH 400 is not recommended to be used during pregnancy.
It may also impair female fertility.

you are breastfeeding or plan to breastfeed

Like most NSAID medicines, CHEMISTS’ OWN IBUPROFEN DOUBLE STRENGTH 400 is not recommended while you are breastfeeding.

you have had any medical conditions, especially the following

heart disease or high blood pressure
heartburn, indigestion, stomach ulcer or any other stomach problems
vomiting blood or bleeding from the back passage
severe skin reactions such as Stevens-Johnson syndrome
asthma
vision problems
liver or kidney disease
tendency to bleed or other blood problems
bowel or intestinal problems such as ulcerative colitis or Crohn’s Disease
heart failure
swelling of the ankles or feet
diarrhoea.

you currently have an infection

If you take CHEMISTS’ OWN IBUPROFEN DOUBLE STRENGTH 400 while you have an infection, it may hide some of the signs and symptoms of an infection. This may make you think, mistakenly, that you are better or that it is not serious.

you plan to have surgery

If you have not told your doctor or pharmacist about any of the above, tell them before you start taking CHEMISTS’ OWN IBUPROFEN DOUBLE STRENGTH 400.

Before you start to take it

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

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

aspirin, salicylate and other non-steroidal anti-inflammatory drugs (NSAIDs)
warfarin, a medicine used to prevent blood clots
lithium, a medicine used to treat mood swings and some types of depression
SSRIs such as sertraline, medicines used to treat depression
medicines used to treat high blood pressure or other heart conditions
medicines used to treat heart failure such as digoxin
diuretics, also called fluid tablets
methotrexate, a medicine used to treat arthritis and some types of cancer
corticosteroids such as prednisone, prednisolone and cortisone, which reduce the activity of your immune system
ciclosporin or tacrolimus, medicines used to treat certain problems with the immune system or to help prevent organ transplant rejection
aminoglycosides, medicines used to treat certain infections
Gingko biloba, a herbal medicine to thin blood
quinolone antibiotics, medicines used to treat certain infections
zidovudine, a medicine used to treat HIV infection
cholestyramine, a medicine used to treat high cholesterol
sulfonylureas, medicines used to treat diabetes
voriconazole or fluconazole, medicines to treat certain fungal infections
mifepristone (RU-486), a medicine used to end pregnancy.

Your doctor and pharmacist will have more information on these and other medicines to be careful with or avoid while using CHEMISTS’ OWN IBUPROFEN DOUBLE STRENGTH 400.

HOW TO TAKE CHEMISTS’ OWN IBUPROFEN DOUBLE STRENGTH 400

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 box, ask your pharmacist or doctor for help.

How much to take

Adults and Children from 12 years:

One tablet every 4 to 6 hours as necessary.

Do not take more than 3 tablets in 24 hours.

Do not give to children under 12.

Do not take more than the recommended dose.

How to take it

Take CHEMISTS’ OWN IBUPROFEN DOUBLE STRENGTH 400 by mouth with water. Do not chew the tablets.

How long to take it

CHEMISTS’ OWN IBUPROFEN DOUBLE STRENGTH 400 should not be used for more than 3 days at a time, except on medical advice.

If you take too much (overdose)

Immediately telephone your doctor of the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much CHEMISTS’ OWN IBUPROFEN DOUBLE STRENGTH 400. Do this even if there are no signs of discomfort or poisoning.

WHILE YOU ARE TAKING CHEMISTS’ OWN IBUPROFEN DOUBLE STRENGTH 400

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking CHEMISTS’ OWN IBUPROFEN DOUBLE STRENGTH 400.

Tell any other doctors, dentists and pharmacists that are treating you that you are taking this medicine.

If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine. NSAID medicines can slow down blood clotting.

If you become pregnant while taking this medicine, tell your doctor immediately.

If you get an infection while taking this medicine, tell your doctor. CHEMISTS’ OWN IBUPROFEN DOUBLE STRENGTH 400 may hide some of the signs of an infection and may make you think mistakenly, that you are better or that it is not serious. Signs of an infection may include fever, pain, swelling and redness.

Tell your doctor if you get any visual disturbances such as blurred vision. You may need to have an eye examination to make sure CHEMISTS’ OWN IBUPROFEN DOUBLE STRENGTH 400 is not causing any side effects.

Things you must not do

Do not take any other medicines to relieve pain and reduce inflammation while you are taking CHEMISTS’ OWN IBUPROFEN DOUBLE STRENGTH 400 without first telling your doctor.

This includes:

aspirin (also called acetylsalicylic acid)
other medicines containing ibuprofen, the active ingredient in CHEMISTS’ OWN IBUPROFEN DOUBLE STRENGTH 400
any other NSAID medicine

Do not take CHEMISTS’ OWN IBUPROFEN DOUBLE STRENGTH 400 to treat any other complaints unless your pharmacist or doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Do not take 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 CHEMISTS’ OWN IBUPROFEN DOUBLE STRENGTH 400.

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

Be careful driving or operating machinery until you know how CHEMISTS’ OWN IBUPROFEN DOUBLE STRENGTH 400 affects you. This medicine may cause dizziness in some people. If this happens, do not drive or operate machinery.

SIDE EFFECTS

Tell your pharmacist or doctor as soon as possible if you do not feel well while you are taking CHEMISTS’ OWN IBUPROFEN DOUBLE STRENGTH 400.

This medicine may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of these side effects.

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

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

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

nausea or vomiting, heartburn or pain in the upper part of your stomach.
loss of appetite;
cramps, wind, constipation, or diarrhoea;
dizziness;
drowsiness;
headache;
buzzing or ringing in the ears or other trouble hearing;
sleeplessness;
changes in mood, for example feeling anxious, depression, confusion, or nervousness.

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

Tell your doctor as soon as possible if you:

severe pain or tenderness in the stomach
eye problems such as blurred vision, sore red eyes, itching
signs of frequent or worrying infections such as fever, severe chills, sore throat or mouth ulcers
bleeding or bruising more easily than normal, reddish or purplish blotches under the skin
signs of anaemia, such as tiredness, headaches, being short of breath, and looking pale
yellowing of the skin and/or eyes, also called jaundice
unusual weight gain, swelling of ankles or legs
tingling of the hands and feet
symptoms of sunburn (such as redness, itching, swelling, blistering) which may occur more quickly than normal
severe or persistent headache
fast or irregular heartbeats, also called palpitations.

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

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

vomiting blood or material that looks like coffee grounds
bleeding from the back passage, black sticky bowel motions (stools) or bloody diarrhoea
swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing
asthma, wheezing, shortness of breath
sudden or severe itching, skin rash, hives
severe blisters and bleeding in the lips, eyes, mouth, nose and genitals (Stevens Johnson Syndrome)
fever, generally feeling unwell, nausea, stomach ache, headache and stiff neck
hearing difficulties, ringing in the ears.

CHEMISTS’ OWN IBUPROFEN DOUBLE STRENGTH 400 may be associated with a small increased risk of heart attack (myocardial infarction).

Blood disorders and kidney problems may occur with CHEMISTS’ OWN IBUPROFEN DOUBLE STRENGTH 400.

The above 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.

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

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

AFTER TAKING CHEMISTS’ OWN IBUPROFEN DOUBLE STRENGTH 400

Storage

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

Keep your medicine in a cool dry place where the temperature stays below 30°C.

Do not store CHEMISTS’ OWN IBUPROFEN DOUBLE STRENGTH 400 or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep it 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.

Disposal

Ask your pharmacist what to do with any medicine that is left over, or if the expiry date has passed.

PRODUCT DESCRIPTION

What it looks like

CHEMISTS’ OWN IBUPROFEN DOUBLE STRENGTH 400 tablets are pink colour, round, biconvex film-coated tablets (may have minor colour specs on tablet surface) debossed with “I 400” on one side and plain on the other side.

Ingredients

CHEMISTS’ OWN IBUPROFEN DOUBLE STRENGTH 400 tablets contain 400 mg ibuprofen as the active ingredient.

Each tablet also contains:

maize starch;
croscarmellose sodium;
povidone;
colloidal anhydrous silica;
sodium starch glycollate;
magnesium stearate;
hypromellose;
purified talc;
titanium dioxide;
macrogol 6000; and
FD&C Red 40 aluminium lake.

This medicine does not contain gluten, wheat, lactose or preservatives.

Packaging

CHEMISTS’ OWN IBUPROFEN DOUBLE STRENGTH 400 is available in blister packs* of 2, 4, 10, 12, 20, 24, 30, 36, 40, 48 and 50 tablets.

*Not all pack sizes are marketed.

Supplier

Arrow Pharma Pty Ltd
15 – 17 Chapel Street
Cremorne VIC 3121

Australian Registration Numbers

CHEMISTS’ OWN IBUPROFEN DOUBLE STRENGTH 400:

400 mg - AUST R 289396

This leaflet was prepared in October 2020

Published by MIMS December 2020

BRAND INFORMATION

Brand name

Chemists' Own Ibuprofen Double Strength 400

Active ingredient

Ibuprofen

Schedule

1 Name of Medicine

Ibuprofen.

2 Qualitative and Quantitative Composition

Chemists' Own Ibuprofen Double Strength 400 tablets contain 400 mg ibuprofen as the active ingredient.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Chemists' Own Ibuprofen Double Strength 400 is supplied as pink coloured, round, biconvex film-coated tablets (may have minor colour specs on tablet surface) debossed with "I 400" on one side and plain on the other side.

4 Clinical Particulars

4.1 Therapeutic Indications

The temporary relief of 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, arthritis, rheumatic pain and the aches and pains associated with colds and flu. Reduces fever.

4.2 Dose and Method of Administration

Chemists' Own Ibuprofen Double Strength 400 tablets are to be administered orally with plenty of water. They should be swallowed whole and not chewed, broken, crushed or sucked on. One tablet every 4 to 6 hours as necessary. The respective dosing interval should be chosen in line with the observed symptoms and the maximum recommended daily dose.
Do not take more than 3 tablets in 24 hours. Chemists' Own Ibuprofen Double Strength 400 should not be used for more than 3 days at a time, except on medical advice.
Not to be used for children under 12 years of age.

4.3 Contraindications

Known hypersensitivity to ibuprofen or any of the inactive ingredients.
Hypersensitivity (e.g. asthma, rhinitis or urticaria) to aspirin or other nonsteroidal anti-inflammatory drugs.
History or active gastrointestinal bleeding or perforation related to previous NSAID therapy.
History or active, ulcerative colitis, Crohn's disease, recurrent peptic ulceration or gastrointestinal haemorrhage (defined as two or more distinct episodes of proven ulceration or bleeding).
Severe heart failure (NYHA IV).
Patients with severe hepatic impairment.
Treatment of perioperative pain in setting of coronary artery bypass surgery (CABG).
Severe renal failure (glomerular filtration below 30 mL/min).
Conditions involving an increased tendency or active bleeding.
During the third trimester of pregnancy.
Pregnancy - see Section 4.6 Fertility, Pregnancy and Lactation, Use in pregnancy.
Lactation - see Section 4.6 Fertility, Pregnancy and Lactation, Use in lactation.

4.4 Special Warnings and Precautions for Use

General.

Prolonged use of any painkillers may induce headaches, which must not be treated with increased doses of the painkillers, including ibuprofen.
Through concomitant consumption of alcohol, NSAID-related undesirable effects, particularly those that concern the gastrointestinal tract or the central nervous system, may be increased on use of NSAIDs.

Cardiovascular thrombotic events.

Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400 mg/day) or increased duration of use, may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Patients with cardiovascular disease, history of atherosclerotic cardiovascular disease or cardiovascular risk factors may also be at greater risk. Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2400 mg/day) should be avoided.
Careful consideration should also be exercised before initiating long-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses of ibuprofen (2400 mg/day) are required.
To minimize the potential risk of an adverse cardiovascular event in patients taking an NSAID, especially in those with cardiovascular risk factors, the lowest effective dose should be used for the shortest possible duration (see Section 4.2 Dose and Method of Administration).
Physicians and patients should remain alert for such CV events, even in the absence of previous CV symptoms. Patients should be informed about signs and/or symptoms of serious CV toxicity and the steps to take if they occur.
There is no consistent evidence that the concurrent use of aspirin mitigates the possible increased risk of serious cardiovascular thrombotic events associated with NSAID use.

Hypertension.

NSAIDs may lead to onset of new hypertension or worsening of pre-existing hypertension and patients taking antihypertensives with NSAIDs may have an impaired anti-hypertensive response. Caution is advised when prescribing NSAIDs to patients with hypertension. Blood pressure should be monitored closely during initiation of NSAID treatment and at regular intervals thereafter.

Heart failure.

Fluid retention and oedema have been observed in some patients taking NSAIDs, therefore caution is advised in patients with fluid retention or heart failure.

Gastrointestinal events.

Ibuprofen should be used with extreme caution, and at the lowest effective dose, in patients with a history of gastro-intestinal haemorrhage or peptic ulcer since their condition may be exacerbated.
All NSAIDs can cause gastrointestinal discomfort and serious, potentially fatal gastrointestinal effects such as ulcers, bleeding and perforation which may increase with dose or duration of use, particularly if complicated with haemorrhage or perforation, and in the elderly. These patients should commence treatment on the lowest dose available. These adverse events can occur at any time without warning or a previous history of serious gastrointestinal events. Upper GI ulcers, gross bleeding or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3-6 months and in about 2-4% of patients treated for one year. These trends continue with longer duration of use, increasing the likelihood of developing a serious GI event at some time during the course of therapy. However, even short-term therapy is not without risk.
Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, as well as patients requiring concomitant low dose aspirin, or for other drugs likely to increase gastrointestinal risk (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
The concomitant administration of ibuprofen and other NSAIDs, including cyclooxygenase-2 (COX-2) selective inhibitors, should be avoided due to the increased risk of ulceration or bleeding (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Caution is advised in patients with risk factors for gastrointestinal events who may be at greater risk of developing serious gastrointestinal events, e.g. the elderly, those with a history of serious gastrointestinal events, smoking and alcoholism. When gastrointestinal bleeding or ulcerations occur in patients receiving NSAIDs, the drug should be withdrawn immediately. Doctors should warn patients about signs and symptoms of serious gastrointestinal toxicity.
Caution should be exercised in patients receiving concomitant medication which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin re-uptake inhibitors or antiplatelet drugs such as aspirin (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
The concurrent use of aspirin and NSAIDs also increases the risk of serious gastrointestinal adverse events.

Severe skin reactions.

NSAIDs may very rarely cause serious cutaneous adverse events such as exfoliative dermatitis, toxic epidermal necrolysis (TEN) and Stevens-Johnson Syndrome (SJS), which can be fatal and occur without warning. These serious adverse events are idiosyncratic and are independent of dose or duration of use. Acute generalised exanthematous pustulosis (AGEP) has been reported in relation to ibuprofen-containing products. Patients should be advised of the signs and symptoms of serious skin reactions and to consult their doctor at the first appearance of a skin rash or any other sign of hypersensitivity.
Severe skin infections and soft-tissue complications may occur in patients with a varicella infection. The role of NSAIDs in the worsening of these infections is uncertain, therefore it is advisable to avoid the use of ibuprofen in known or suspected cases of varicella.

Infections and infestations.

Exacerbation of infection-related inflammations (e.g. development of necrotising fasciitis) coinciding with the use of NSAIDs has been described. If signs of an infection occur or get worse during use of ibuprofen the patient is therefore recommended to go to a doctor without delay.

Respiratory disorders.

Caution is required if ibuprofen is administered to patients suffering from, or with a previous history of, bronchial asthma, chronic rhinitis or allergic diseases since ibuprofen has been reported to cause bronchospasm, urticarial or angioedema in such patients.

Ophthalmological effects.

Adverse ophthalmological effects have been observed with NSAIDs; accordingly, patients who develop visual disturbances during treatment with ibuprofen should have an ophthalmological examination.

Combination use of ACE inhibitor or angiotensin receptor antagonists, anti-inflammatory drugs and thiazide diuretics.

The use of an ACE inhibiting drug (ACE-inhibitor or angiotensin receptor antagonist), an anti-inflammatory drug (NSAID or COX-2 inhibitor) and thiazide diuretic at the same time increases the risk of renal impairment. This includes use in fixed-combination products containing more than one class of drug. Combined use of these medications should be accompanied by increased monitoring of serum creatinine, particularly at the initiation of the combination. The combination of drugs from these three classes should be used with caution particularly in elderly patients or those with pre-existing renal impairment.

Aseptic meningitis.

Aseptic meningitis has been reported only rarely, usually but not always in patients with systemic lupus erythematosus (SLE) or other connective tissue disorders.

Haematological monitoring.

Blood dyscrasias have been rarely reported. Patients on long-term therapy with ibuprofen should have regular haematological monitoring.

Coagulation defects.

Like other NSAIDs, ibuprofen can inhibit platelet aggregation. Ibuprofen has been shown to prolong bleeding time (but within the normal range), in normal subjects. Because this prolonged bleeding effect may be exaggerated in patients with underlying haemostatic defects, ibuprofen should be used with caution in persons with intrinsic coagulation defects and those on anti-coagulation therapy.

Masking signs of infection.

As with other drugs of this class, ibuprofen may mask the usual signs of infection.

Special precautions.

In order to avoid exacerbation of disease or adrenal insufficiency, patients who have been on prolonged corticosteroid therapy should have their therapy tapered slowly rather than discontinued abruptly when ibuprofen is added to the treatment program.

Use in labour and delivery.

Administration of ibuprofen is not recommended during labour and delivery. The onset of labour may be delayed and the duration increased with a greater bleeding tendency in both mother and child.

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.
Physicians and patients should remain alert for hepatotoxicity. Patients should 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) and the steps to take should these signs and/or symptoms occur. Patients with impaired liver function or a history of liver disease who are on long term ibuprofen therapy should have hepatic function monitored at regular intervals. Ibuprofen has been reported to have a minor and transient effect on liver enzymes.
Severe hepatic reactions, including jaundice and cases of fatal hepatitis, though rare, have been reported with ibuprofen as with other NSAIDs. If abnormal liver tests persist or worsen, or if clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g. eosinophilia, rash, etc.), ibuprofen should be discontinued.

Use in renal impairment.

Caution should be used when initiating treatment with ibuprofen in patients with considerable dehydration. There is a risk of renal impairment especially in dehydrated children, adolescents and in the elderly.
The two major metabolites of ibuprofen are excreted mainly in the urine and impairment of renal function may result in their accumulation. The significance of this is unknown. NSAIDs have been reported to cause nephrotoxicity in various forms; interstitial nephritis, nephrotic syndrome and renal failure. In patients with renal, cardiac or hepatic impairment, those taking diuretics and ACE Inhibitors, and the elderly, caution is required since the use of NSAIDs may result in deterioration of renal function. The long term concomitant intake of similar analgesics further increases the risk. For patients with renal, hepatic or cardiac impairment, use the lowest effective dose, for the shortest possible duration and monitor renal function especially in long term treated patients.

Use in the elderly.

Elderly patients 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

Care should be taken in patients treated with anti-coagulants, such as warfarin, due to an enhanced effect of anti-coagulants.
Concurrent use of NSAIDs and warfarin has been associated with severe sometimes fatal haemorrhage. The mechanism of this interaction is not known but may involve increased bleeding from NSAID-induced gastrointestinal ulceration or an additive effect of NSAID inhibition of platelet function with the anticoagulant effect of warfarin.
Ibuprofen should only be used in patients taking warfarin if absolutely necessary. Patients taking this combination must be closely monitored.

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

Increased risk of gastrointestinal bleeding.

Aminoglycosides.

NSAIDs may decrease the excretion of aminoglycosides.
Ibuprofen has been shown to decrease the renal clearance and increase plasma concentrations of lithium. Lithium plasma concentrations should be monitored in patients on concurrent ibuprofen therapy.
Ibuprofen like other NSAIDs can reduce the antihypertensive effect of ACE inhibitors, angiotensin II-receptor antagonists and beta-blockers with possible loss of blood pressure control and can attenuate the natriuretic effects of diuretics. Diuretics can also increase the risk of nephrotoxicity of NSAIDs. The combined use of the three classes of drugs, diuretics, an ACE inhibiting drug (ACE-inhibitor or angiotensin receptor antagonist) and an anti-inflammatory drug (NSAID or COX-2 inhibitor) all at the same time increases the risk of renal impairment (see Section 4.4 Special Warnings and Precautions for Use).
NSAIDs may exacerbate cardiac failure, reduce glomerular filtration rate and increase plasma cardiac glycoside levels. Care should therefore be taken in patients treated with cardiac glycosides.

Cholestyramine.

The concomitant administration of ibuprofen and cholestyramine may reduce the absorption of ibuprofen in the gastrointestinal tract. However, the clinical significance is unknown.

Corticosteroids.

Increased risk of gastrointestinal bleeding.

Herbal extracts.

Ginkgo biloba may potentiate the risk of bleeding with NSAIDs.

Other analgesics.

Avoid concomitant use of two or more NSAIDs, including aspirin and cyclooxygenase-2 (COX-2) selective inhibitors, because of the potential of increased adverse effects. Ibuprofen antagonizes the irreversible inhibition of platelet COX-1 induced by low dose aspirin. To reduce this effect, ibuprofen should be administered at least 8 hours before or 30 minutes after taking low dose aspirin.
Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. Some pharmacodynamics studies show that when a single dose of ibuprofen 400 mg were taken within 8 hours before or within 30 minutes after immediate release aspirin dosing (81 mg), and when multiple daily doses of ibuprofen 400 mg are given with aspirin, a decreased effect of acetylsalicylic acid on the formation of thromboxane or platelet aggregation occurred. Although there are uncertainties regarding extrapolation of this data to the clinical situation the possibility that regular, long term use of ibuprofen may reduce the cardio-protective effect of aspirin cannot be excluded. No clinically relevant effect is considered to be likely for occasional ibuprofen use.

Cyclosporine or tacrolimus.

Increased risk of nephrotoxicity when used with NSAIDs.

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.

Sulfonylureas.

NSAIDs may potentiate the effects of sulfonylurea medications. There have been rare reports of hypoglycaemia in patients on sulfonylurea medications receiving ibuprofen.

Zidovudine.

Increased risk of haematological toxicity when NSAIDs are given with zidovudine. There is evidence of an increased risk of hemarthrosis and hematoma in HIV(+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.
NSAIDs inhibit tubular secretion of methotrexate in animals. As a result, reduction of clearance of methotrexate may occur. Use of high doses of methotrexate concomitant with NSAIDs should be avoided. At low doses of methotrexate caution should be used if ibuprofen is administered concomitantly.

CYP2C9 inhibitors.

Concomitant administration of ibuprofen with CYP2C9 inhibitors may increase the exposure to ibuprofen (CYP2C9 substrate). In a study with voriconazole and fluconazole (CYP2C9 inhibitors), an increased S(+)-ibuprofen exposure by approximately 80 to 100% has been shown. Reduction of the ibuprofen dose should be considered when potent CYP2C9 inhibitors are administered concomitantly, particularly when high-dose ibuprofen is administered with either voriconazole or fluconazole.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

The use of ibuprofen may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of ibuprofen should be considered.
(Category C)
(Category C): Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing harmful effects on the human foetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.
Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in early pregnancy. The risk is believed to increase with dose and duration of therapy. In animals, the administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation losses and embryo/foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period.
During the first and second trimester of pregnancy, ibuprofen should not be given unless clearly necessary. If ibuprofen is used by a woman attempting to conceive, or during the first or second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to the following:
cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
renal dysfunction, which may progress to renal failure with oligohydramnios.
At the end of the pregnancy, prostaglandin synthesis inhibitors may expose the mother and the neonate to the following:
possible prolongation of bleeding time;
inhibition of uterine contractions, which may result in delayed or prolonged labour.
Consequently, ibuprofen is contraindicated during the third trimester of pregnancy.
Ibuprofen is not recommended for use in nursing mothers.

4.7 Effects on Ability to Drive and Use Machines

Following treatment with ibuprofen, the reaction time of patients may be affected. This should be taken into account where increased vigilance is required, e.g. when driving a car or operating machinery.

4.8 Adverse Effects (Undesirable Effects)

The following adverse reactions possibly related to ibuprofen displayed by MedDRA frequency convention and system organ classification. Frequency groupings are classified according to the subsequent conventions: Very common (≥ 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) and Not known (cannot be estimated from the available data). See Table 1.

Precise incidence unknown (but greater than 1%) causal relationship unknown.

Gastrointestinal.

Epigastric pain, heartburn, abdominal distress, abdominal cramps and bloating.

Auditory and vestibular.

Tinnitus, hearing impaired.

Cardiovascular.

Oedema, fluid retention; fluid retention generally responds promptly to discontinuation of the drug.

Central nervous system.

Nervousness.

Dermatological.

Pruritus.

General.

Decreased appetite.

Precise incidence unknown (but less than 1%) causal relationship unknown.

Central nervous system.

Emotional lability, somnolence, hallucinations and dream abnormalities.

Dermatological.

Alopecia.

Gastrointestinal.

Abnormal liver function tests.

Haematological.

Eosinophilia and decrease in haemoglobin and haematocrit.

Ocular.

Amblyopia (blurred and/or diminished vision, scotomata and/or changes in colour vision) have occurred but is usually reversed after cessation of therapy. Any patient with eye complaints should have an ophthalmological examination which includes central vision fields (see Section 4.4 Special Warnings and Precautions for Use). Visual impairment and toxic neuropathy have also been reported.

Allergic.

Serum sickness, lupus erythematosus syndrome, Henoch-Schönlein vasculitis and chills.

Special senses.

Conjunctivitis, diplopia and cataracts.

Haematological.

Bleeding episodes (e.g. epistaxis, menorrhagia).

Metabolic/endocrine.

Gynaecomastia, hypoglycaemic reaction, acidosis.

Cardiovascular.

Arrhythmias (sinus tachycardia, sinus bradycardia).

Additional post-marketing adverse reactions.

Adverse reactions have been reported during post-approval use of ibuprofen. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to ibuprofen exposure.

Gastrointestinal.

Exacerbation of colitis and Crohn's disease (see Section 4.3 Contraindications). Pancreatitis has been reported very rarely.

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

Most patients who have ingested significant amounts of ibuprofen will manifest symptoms within 4 to 6 hours.
Symptoms include nausea, abdominal pain and vomiting, lethargy, and drowsiness. Central nervous system (CNS) effects including heading, tinnitus, dizziness, convulsion and rarely, loss of consciousness. Clinical features of overdose with ibuprofen which may result are nystagmus, metabolic acidosis, hypothermia, renal effects, gastrointestinal bleeding, coma, apnea and depression of the central nervous system and the respiratory system have also been rarely reported. Cardiovascular toxicity, including hypotension, bradycardia and tachycardia, has been reported. In cases of significant overdose, renal failure and liver damage are possible. Large overdoses are generally well tolerated when no other drugs are being taken.
There is no specific antidote to ibuprofen. Patients should be treated symptomatically as required. Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered. If necessary, serum electrolyte balance should be corrected.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Ibuprofen is a nonsteroidal anti-inflammatory agent that possesses analgesic and antipyretic activities. Its mode of action, like that of other nonsteroidal anti-inflammatory agents, is not completely understood, but may be related to prostaglandin synthetase inhibition.
Ibuprofen has shown anti-inflammatory, analgesic and antipyretic activity in both animal and human studies. These properties provide symptomatic relief of inflammation and pain in rheumatoid arthritis, osteoarthritis and allied conditions.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Ibuprofen is well absorbed after oral administration. Single doses of 200 mg taken on an empty stomach by volunteers produced peak serum levels after approximately 45 minutes. When taken after food, absorption was slower, peak levels appearing 1.5 to 3 hours.

Distribution.

Apparent volume of distribution is 0.14 L/kg. Ibuprofen and its metabolites readily cross the placental barrier in pregnant rabbits and rats. It is not known if the drug enters the CSF or is excreted in breast milk.
The amount of ibuprofen that is protein bound is 99%. The high protein binding of the drug should be borne in mind when prescribing ibuprofen together with other protein bound drugs which bind to the same site on human serum albumin.

Metabolism.

About 90% of ibuprofen is metabolized to two major metabolites (A and B), and these are as follows:
Metabolite A: (+) 2-4'-(2 hydroxy-2-methylpropylphenyl) propionic acid.
Metabolite B: (+) 2-4'-(2-carboxypropylphenyl) propionic acid.
Both metabolites are dextrorotatory and are devoid of anti-inflammatory and analgesic activity. Normal volunteers and patients with rheumatoid arthritis were given 800 mg ibuprofen as a single dose. After 14-24 hours the plasma levels of drug and metabolites were less than 0.25 microgram/mL.

Excretion.

The kidney is the major source of excretion; 95% of the drug was excreted in the urine within 24 hours of a single dose of 500 mg, 35% as metabolite A (15% free, 20% conjugated); 51% as metabolite B (42% free, 9% conjugated); ibuprofen 9% (1% free, 9% conjugated). The plasma 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

In addition to ibuprofen, the tablets contain, in the core, maize starch, croscarmellose sodium, povidone, colloidal anhydrous silica, sodium starch glycollate and magnesium stearate. In the film-coating; hypromellose, purified talc, titanium dioxide, macrogol 6000 and FD and C Red 40 aluminium lake (ID: 104463).
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

Store below 30°C.

6.5 Nature and Contents of Container

Chemists' Own Ibuprofen Double Strength 400 is packed in Alu/PVC blister packs* of 2, 4, 10, 12, 20, 24, 30, 36, 40, 48 or 50 tablets.
* Not all pack sizes are marketed.

6.6 Special Precautions for Disposal

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

6.7 Physicochemical Properties

Ibuprofen is a (±)-2-(p-isobutylphenyl) propionic acid. Ibuprofen is a white crystalline solid with a melting point of 74°C - 77°C and is practically insoluble in water (< 0.1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone.

Chemical structure.

The structural formula for ibuprofen is shown below:

CAS number.

CAS number: 15687-27-1.

7 Medicine Schedule (Poisons Standard)

Pack size 20, 24, 30, 36, 40, 48, 50: S3 - Pharmacist Only Medicine.
Pack size 2, 4, 10, 12: S2 - Pharmacy Medicine.

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Chemists' Own Ibuprofen Double Strength 400 mg Tablets