Consumer medicine information

1. Why am I using CHEMISTS' OWN IBUPROFEN DOUBLE STRENGTH 400?

CHEMISTS' OWN IBUPROFEN DOUBLE STRENGTH 400 contains the active ingredient ibuprofen. CHEMISTS' OWN IBUPROFEN DOUBLE STRENGTH 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. It also reduces fever.
For more information, see Section 1. Why am I using CHEMISTS' OWN IBUPROFEN DOUBLE STRENGTH 400? in the full CMI.

2. What should I know before I use CHEMISTS' OWN IBUPROFEN DOUBLE STRENGTH 400?

Do not use if you have ever had an allergic reaction to ibuprofen, aspirin, NSAIDs or any of the ingredients listed at the end of the CMI.
Talk to your doctor or pharmacist if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use CHEMISTS' OWN IBUPROFEN DOUBLE STRENGTH 400? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with CHEMISTS' OWN IBUPROFEN DOUBLE STRENGTH 400 and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use CHEMISTS' OWN IBUPROFEN DOUBLE STRENGTH 400?

• 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 exceed recommended dose. Excessive use can be harmful and increase the risk of heart attack, stroke or liver damage.

• Take CHEMISTS' OWN IBUPROFEN DOUBLE STRENGTH 400 by mouth with water.

5. What should I know while using CHEMISTS' OWN IBUPROFEN DOUBLE STRENGTH 400?

6. Are there any side effects?

Side effects are uncommon. The most common of these include headache, nausea, abdominal pain and heartburn.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Ibuprofen.

2 Qualitative and Quantitative Composition

Active ingredient: ibuprofen 400 mg.
Excipients with known effect. Contains sugars (as lactose).
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.
Symptoms include nausea, abdominal pain and vomiting, dizziness, convulsion and rarely, loss of consciousness. Clinical features of overdose with ibuprofen which may result are depression of the central nervous system and the respiratory system.
There is no specific antidote to ibuprofen.

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 Chemical formula: C₁₃H₁₈O₂.
Molecular weight: 206.3.
CAS number. 15687-27-1.

7 Medicine Schedule (Poisons Standard)

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

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/IBUPROST.gif