Summary of product characteristics

1. Name of the medicinal product

2. Qualitative and quantitative composition

3. Pharmaceutical form

4.1. Therapeutic indications

4.2. Posology and method of administration

4.3. Contraindications

4.4. Special warnings and precautions for use

4.5. Interaction with other medicinal products and other forms of interaction

4.6. Fertility, pregnancy and lactation

4.7. Effects on ability to drive and use machines

4.8. Undesirable effects

4.9. Overdose

5.1. Pharmacodynamic properties

5.2. Pharmacokinetic properties

5.3. Preclinical safety data

6.1. List of excipients

6.2. Incompatibilities

6.3. Shelf life

6.4. Special precautions for storage

6.5. Nature and contents of container

6.6. Special precautions for disposal and other handling

7. Marketing authorisation holder

8. Marketing authorisation number(s)

9. Date of first authorisation/renewal of the authorisation

10. Date of revision of the text