How to read a Swiss professional product information

What the product information is and is not

The Fachinformation is the approved product information for healthcare professionals. Its content forms part of the authorisation decision, so the authorisation holder cannot change it freely. It differs from the patient information, commonly called the package leaflet, which states the same facts in lay language.

Both texts are published on swissmedicinfo.ch, the official publication platform for Swiss medicinal product information, operated on behalf of Swissmedic. The version published there is the binding one.

Separately, compendium.ch is run by HCI Solutions AG, a company of the Galenica group. That is a commercial product with its own added content, not the official publication. For a regulatory question, swissmedicinfo.ch is the reference.

The sections in their fixed order

Every Swiss product information follows the same outline. It starts with the composition, moves through indication, dosage and safety information to the pharmacological data, and ends with the administrative entries. The order is prescribed, so it is identical across products and authorisation holders.

1. Composition: active substances and excipients, including excipients with a declaration duty such as lactose or benzyl alcohol.
2. Pharmaceutical form and quantity of active substance per unit: tablet, solution for injection, amount per unit.
3. Indications and possible uses: the authorised indications, and nothing beyond them.
4. Dosage and administration: standard dose, special populations, route of administration.
5. Contraindications: absolute contraindications.
6. Warnings and precautions: relative restrictions, monitoring, at-risk populations.
7. Interactions: medicines, food, laboratory values.
8. Pregnancy, lactation: available data and recommendation.
9. Effects on the ability to drive and to use machines.
10. Undesirable effects: ordered by frequency and organ system.
11. Overdose: symptoms and measures.
12. Properties and effects: mechanism of action, pharmacodynamic and clinical data.
13. Pharmacokinetics: absorption, distribution, metabolism, elimination.
14. Preclinical data: animal and in vitro findings.
15. Other information: incompatibilities, shelf life and special storage instructions, handling notes.
16. Authorisation number: the five-digit Swissmedic number.
17. Packs: pack sizes with the dispensing category for each.
18. Authorisation holder: company and registered office.
19. Date of revision of the text: date of the last approved textual change.

Which section answers which question

Most practical questions map to a single section. Once you know which one, you go straight there. The mapping below covers the questions most often put to a product information in day to day regulatory and pharmacy work.

Note that the dispensing category is given per pack. For products with several strengths or pack sizes it can differ from one pack to the next.

Date of revision and safety communications

Each product information ends with the date of revision of the text, the date of the last textual change approved by Swissmedic. It tells you how current the text is. An older date is not an error, but it does mean no textual amendment has been approved since.

Safety information does not always reach professionals through the product information. Swissmedic and authorisation holders send urgent notices as a Direct Healthcare Professional Communication (DHPC) or as a Healthcare Professional Communication. These letters sit outside the product information at first and are folded into it only with an approved text change.

The practical consequence: for a live safety question, check both the product information and the Swissmedic market surveillance publications.

How to look up a medicine

The fastest route starts on a detail page in this directory: authorisation number, authorisation holder and dispensing category are there as structured fields, and from there you reach the full product information on swissmedicinfo.ch.

1. Enter the brand name or active substance in this directory's search.
2. Open the detail page and note the authorisation number and the authorisation holder, especially when several entries share a brand name.
3. Follow the link to swissmedicinfo.ch and search the same brand name there.
4. Choose the Fachinformation rather than the patient information if you need the professional text.
5. Jump to the section that covers your question, using the mapping above.
6. Check the date of revision at the end, and for safety questions add the Swissmedic communications.

This directory carries regulatory facts from the Swissmedic dataset: authorisation number, authorisation holder, dispensing category, pharmaceutical form, active substances. The clinically binding source remains the product information. Nothing on these pages is medical advice or a recommendation to use a medicine.