About Product Information Documents
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 sufficient for ensuring safe and effective use of the medicine under nearly all circumstances.
What a PI contains
The PI contains:
- Name and Description: active and inactive ingredients in the medicine
- Pharmacology: how the medicine affects the body
- Clinical Trials: effectiveness and safety of the medicine when tried in volunteers with the condition the medicine is meant to treat
- Indications: diseases or conditions the medicine is approved to treat
ns: 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 occur, how frequently they occur and how severe they may be
- Dosage and Administration: 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: when the Australian regulatory agency approved the PI
- The PI is written in scientific language aimed at health professionals and may not be easy to understand for anyone who does not have a medical background. We advise consumers to always talk to their doctor or pharmacist about all aspects of their medicines, including why they are taking them and what benefits/risks they can expect.