CRED SMPC 2024

Leaflet requirements (1/4)

1. What is X and what is it used for ?

- Indications - Pharmacotherapeutic group (how it works)

2. What you need to know before you take (use) X

- Do not take (use X): absolute contraindications - Warnings and precautions: information and action to minimise risk - Other medicines and X (also food, drink, and alcohol) - Pregnancy, breastfeeding, and fertility - Driving and using machines - X contains: information about excipients

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7

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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