Glossary

This glossary will help you understand how the Consumer Medicine Information (CMI) and Product Information (PI) are structured so that you can make the best use of the information in them.

Consumer Medicine Information (CMI)

The CMI contains the following information:

• What is in this leaflet: general information on content and may include a table of contents
• What the medicine is used for: the medical conditions that can be treated with the medicine, who the medicine is intended for (adults, children, etc), how the medicine works
• Before you take the medicine:
  • When you must not take it: situations where the medicine must not be taken (e.g. allergies, pregnancy)
  • Before you start to take it: things you must tell your doctor before starting the medicine (e.g. other medical conditions that may affect how the medicine works)
  • Taking other medicines: other medicines you are taking that may affect how the new medicine works
• How to take the medicine: how much to take, when and how to take it, how long to take it, what to do if you forget to take it or if you take too much
• While you are taking the medicine: things you must / must not do and things to be careful of while taking the medicine to make sure it works in the best way possible
• Side effects: the known side effects of the medicine and what to do if you experience any of the symptoms
• After using the medicine: how to store the medicine and how to dispose of it when you no longer need to take it
• Product description: what the medicine looks like, list of all ingredients
• Sponsor: name, address and contact details of the pharmaceutical company that makes the medicine; date the CMI was prepared.

Product Information (PI)

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 trialled 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.