Spring Intro 2023

Leaflet requirements (2/4)

3. How to take (use) X

- Dosage instructions (section 4.2 of SPC) - Use in children and adolescents - Method and route of administration - Frequency of administration - Duration of treatment - If you take (use) more X than you should

- If you forget to take (use) X - If you stop taking (using) X

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Leaflet requirements (3/4)

4. Possible side effects

- Serious side effects that require immediate attention must be listed first, regardless of frequency - Other side effects to be listed according to frequency (most common first) - Clear instructions for action to be taken by patient - Details for patient reporting of side effects

5. How to store X

- Expiry date reference - Storage conditions - In use shelf life (if applicable) - Signs of deterioration (if applicable) - Disposal

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