Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Pharmacy Action Ibuprofen 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 pharmacist or doctor has weighed the risks of you taking Pharmacy Action Ibuprofen 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 Pharmacy Action Ibuprofen 400 is used for

Pharmacy Action Ibuprofen 400 is used for 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.

Before you take Pharmacy Action Ibuprofen 400

When you must not take it

• any medicine containing ibuprofen, aspirin or other NSAIDs;

• any of the ingredients listed at the end of this leaflet.

• asthma, wheezing or shortness of breath;

• swelling of the face, lips or tongue which may cause difficulty breathing;

• hives, itching or skin rash;

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

• fainting.

• have asthma that is sensitive to aspirin or NSAIDs;

• have a peptic ulcer (ie. stomach or duodenal ulcer), a recent history of one, or have had peptic ulcers before;

• have recently (or have previously) vomited blood or material that looks like coffee grounds;

• have recently (or previously) bled from the back passage (rectum), had black sticky bowel motions (stools) or bloody diarrhoea;

• have a condition resulting in an increased tendency to bleed;

• have a history of, Ulcerative Colitis or Crohn’s Disease;

• have severe kidney disease;

• have severe heart failure;

• have severe liver disease;

• are being treated for pain following heart bypass surgery.

Before you start to take it

• any other medicines including aspirin or other NSAID medicines;

• any other substances, such as foods, preservatives or dyes.

• asthma;

• 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;

• vision problems;

• liver or kidney disease;

• tendency to bleed or other blood problems;

• bowel or intestinal problems such as ulcerative colitis;

• heart failure;

• swelling of ankles or feet;

• diarrhoea.

Taking other medicines

• warfarin or clopidogrel, medicines used to stop 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;

• methotrexate, a medicine used to treat arthritis and some types of cancer;

• medicines used to treat heart failure such as digoxin;

• medicines such as prednisone, prednisolone and cortisone, which reduce the activity of your immune system;

• cyclosporine 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;

• quinolone antibiotics, medicines used to treat certain infections;

• mifepristone, a medicine used to bring about an abortion;

• zidovudine, a medicine used to treat HIV infection;

• aspirin, salicylates and other NSAIDs;

• medicines used to treat diabetes;

• probenecid, a medicine used to treat gout;

• phenytoin, a medicine used to treat epilepsy.

How to take Pharmacy Action Ibuprofen 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 container, ask your pharmacist or doctor for help.

How much to take

How to take it

How long to take it

If you take too much (overdose)

While you are taking Pharmacy Action Ibuprofen 400

Things you must do

Things you must not do

Things to be careful of

Side effects

Tell your pharmacist or doctor as soon as possible if you do not feel well while you are taking Pharmacy Action Ibuprofen 400.
This medicine may have unwanted side effects in a few people. As with most medicines, if you are over 65 years of age, you may have an increased chance of getting side effects.
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 the 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 questions you may have.
It is rare to get side effects from ibuprofen if taken for a short period of time and in the doses in non-prescription (over the counter) medicines.
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;

• sleepiness;

• buzzing or ringing in the ears or other trouble hearing;

• headache;

• sleeplessness;

• changes in mood, for example depression, confusion, nervousness.

• 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, welling 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 usual;

• severe or persistent headache;

• fast or irregular heartbeats, also called palpitations.

• fluid retention;

• vomiting blood or material that looks like coffee grounds;

• bleeding from the back passage, black sticky bowel motions (stools) or bloody diarrhoea;

• shortness of breath;

• asthma, wheezing or difficulty breathing;

• swelling of the face, lips, tongue which may cause difficulty in swallowing or breathing;

• 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.

After taking Pharmacy Action Ibuprofen 400

Storage

Disposal

Product description

What it looks like

Ingredients

• Lactose monohydrate

• Microcrystalline cellulose

• Povidone

• Croscarmellose sodium

• Sodium lauryl sulfate

• Colloidal anhydrous silica

• Stearic acid

• Macrogol 6000

• Hypromellose

• Titanium dioxide

• Purified talc

• Purified water

Australian Registration Numbers

Sponsor

1 Name of Medicine

Ibuprofen.

2 Qualitative and Quantitative Composition

Each tablet contains Ibuprofen 400 mg.
List of excipients with known effect. Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

White to off-white, pillow-shaped, film coated tablets, plain on both sides.

4 Clinical Particulars

4.9 Overdose

In case of overdose, immediately contact the Poisons Information centre (in Australia please call 13 11 26 and in New Zealand 0800 764 766) for advice.
In adults the dose response effect is less clear cut than in children where ingestion of more than 400 mg/kg may cause symptoms. The half-life in overdose is 1.5-3 hours.
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 vertigo, drowsiness, occasionally excitation and disorientation or coma. Occasionally patients develop convulsions. In serious poisoning hyperkalaemia and 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, liver damage, hypotension, respiratory depression and cyanosis may occur. Exacerbation of asthma is possible in asthmatics.
Management: management should be symptomatic and supportive and include the maintenance of a clear airway and monitoring of cardiac and vital signs until stable. Consider oral administration of activated charcoal if the patient presents within 1 hour of ingestion of a potentially toxic amount. If frequent or prolonged, convulsions should be treated with intravenous diazepam or lorazepam. Give bronchodilators for asthma.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Ibuprofen is a (±)-2-(p-isobutylphenyl) propionic acid. Ibuprofen is a white crystalline solid with a melting point of 74 - 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.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSIBUPRN.gif Molecular Formula: C₁₃H₁₈O₂.
Molecular Weight: 206.3.
CAS number. 15687-27-1.

7 Medicine Schedule (Poisons Standard)

S3 - Pharmacist Only Medicine (Pack sizes 20, 30, 40 and 50).
S2 - Pharmacy Medicine (Pack sizes 10 and 12).

Summary Table of Changes

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