Product Information (PI) is a technical document that helps guide health professionals on the best way to use a medicine. The PI is a scientific, objective account of a medicine's usefulness and limitations. It contains medicine information that is sufficient to ensure safe and effective use of the medicine under nearly all circumstances.

The PI generally contains the following information:

• Name and Description: of the active and inactive ingredients in the medicine
• Pharmacology: how the medicine affects the body
• Clinical Trials: the effectiveness and safety of the medicine when tried in volunteers with the medical condition that the medicine will be used for
• Indications: the diseases or conditions that the medicine is approved to treat
• Contraindications: situations where the medicine should not be used
• Precautions: situations where the medicine should be used carefully such as pregnancy, breast-feeding, in the presence of other medical conditions, together with other medicines
• Adverse Reactions: side effects that might happen, how frequently they happen and how severe they may be
• Dosage and Administration: the recommended dose and how the medicine should be taken
• Overdose: symptoms and treatment if too much medicine is taken
• Presentation: what the medicine looks like, pack sizes and storage conditions
• Date of approval: date the PI was approved by the Australian regulatory agency

Important notes:

• If you are not a health professional, bear in mind that the PI is written in scientific language and may not be easy to understand if you do not have a medical background. Always talk to your doctor or pharmacist about all aspects of your medicines, including why you are taking them and what benefits / risks you can expect.
• The information on this web site relates to the use of medicine information in Australia only.