Table 1. The EU template for patient information about medicines compared with its US and Australian counterparts.
US and AU templates have been reordered for comparison (but not renumbered).
| EU template | US template | Australian template |
|---|---|---|
| 1. What is the most important information…? | 1. What is in this leaflet? | |
| 1. What X is and what it is used for | 2. What is X? | 2. What is X used for? |
| 2. What you need to know before you <take> <use> X | 3. Before you take X | |
| Do not take X if: | 3. Who should not take X? | When you must not take it |
| Warnings and precautions | Before you start to take it | |
| Children <and adolescents> | ||
| Other medicines and X | Taking other medicines | |
| X with food, drink and alcohol | 5. What should I avoid while taking? | 5. While you are taking X |
| Pregnancy and breast-feeding | Things you must do | |
| Driving and using machines | Things you must not do | |
| Things to be careful of | ||
| This medicine contains | ||
| 3. How to <take> <use> X | 4. How should I take? | 4. How to take X? |
| <Use in children <and adolescents>> | How much to take | |
| <If you <take> <use> more X than you should> | How to take it | |
| <If you forget to <take> <use> X> | When to take it | |
| <If you stop <taking> <using> X> | How long to take it | |
| If you forget to take it | ||
| If you take too much | ||
| 4. Possible side effects | 6. What are the possible or reasonably expected side effects? | 6. Side effects |
| <Additional side effects in children <and adolescents > | ||
| 5. How to store X | 7. After taking X | |
| Storage | ||
| Disposal | ||
| 6. Contents of the pack and other information | 7. General information | 8. Product description |
| What X contains | Ingredients | |
| What X looks like and contents of the pack | What it looks like | |
| Marketing Authorisation Holder and Manufacturer | Manufacturer |