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:

  • Name of the medicine and active ingredient
  • Dosage of the medicine
  • What the medicine is used for and how it works: the medical conditions that can be treated with the medicine, who the medicine is intended for (adults, children, etc), how the medicine works
  • Warnings and precautions, such as when the medicine should not be taken
    • 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)
    • When you must not take it: situations where the medicine must not be taken (e.g. allergies, pregnancy)
  • Interactions the medicine might have with food or other medicines: other medicines you are taking that may affect how the new medicine works
  • How to use the medicine properly: 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
  • What to do in the case of an overdose
  • How to store the medicine properly: how to store the medicine and how to dispose of it when you no longer need to take it
  • Side effects: the known side effects of the medicine and what to do if you experience any of the symptoms
  • Product details: Names of the active and inactive ingredients and description of medication
  • Name and address of the sponsor: name, address and contact details of the pharmaceutical company that makes the medicine
  • Date the CMI was last updated

Product Information (PI)

The PI generally contains the following information:

  • Name of the medicine: The Australian Approved Name (AAN) of the therapeutically active ingredient or, in the case of a fixed dose combination or composite pack containing multiple therapeutically active ingredients, the AAN of each therapeutically active ingredient.
  • Composition and pharmaceutical form: A description of the formulation(s) including quantity, proportion or strength of each therapeutically active ingredient.
  • Clinical particulars, including:
    • Therapeutic indications: the diseases or conditions that the medicine is approved to treat
    • Dose and method of administration: the recommended dose and how the medicine should be taken/used
    • Contraindications: situations where the medicine should not be used
    • Special warning and precautions for use: 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 effects: side effects that might happen, how frequently they happen and how severe they may be
    • Overdose: symptoms and treatment if too much medicine is taken
  • Pharmacological properties: how the medicine affects the body.
    This section includes:
    • Pharmacodynamic properties
    • Clinical trials
    • Pharmacokinetic properties
  • Pharmaceutical properties, including:
    • List of excipients
    • Incompatibilities
    • Special precautions for storage and disposal
  • Medicine schedule: Scheduling is a national classification system that controls how medicines and chemicals are made available to the public.
  • Sponsor: Name, street address and contact details of the sponsor of the medicine.
  • Date(s) of approval and revision: date the PI was approved and/or revised by the Australian regulatory agency.