Just as for the passage "... or ask your doctor or pharmacist.", which we know from television advertising as a compulsory statement, there are compulsory statements for medicines, devices or machines so that they receive approval for end consumers - from the pharmaceutical industry or from TÜV or other institutions. machines, so that they receive approval for end consumers - from the pharmaceutical industry or from TÜV or other institutions.
Package leaflet, instruction leaflet and directions for use - what information must be included?
Grob vereinfacht: Arzneimittel müssen gekennzeichnet werden, welche Bestandteile sie enthalten, welche Wirkung sie haben, unter welchen Umständen eine Einnahme hilfreich oder risikoreich sein kann, wie die Nebenwirkungen sind, welche Zusammensetzung das Medikament enthält, welche Risiken durch die Einnahme entstehen können, was z. B. bei einer Schwangerschaft zu beachten ist, welche Nebenwirkung der Patient im Allgemeinen zu erwarten hat und vieles mehr. Aus der Packungsbeilage muss hervorgehen, was das Arzneimittel bewirkt und was z. B. bei einer Überdosierung zu beachten ist.
The interaction with other medicines may also be important, or if the patient already has pre-existing conditions, just what to consider in this case. The patient should be understanding of how to take the medicine or medicines. The information should also include a range for the frequency of use and the treatment in general. contain. It usually contains information and guidelines for use in specific diseases and associated risks. At the pharmacy, the consumer can also ask about the effects of the medicine. The pharmacist is very familiar with the requirements. He usually has a database at his disposal that provides information on incompatibilities for patients.
Service for the pharmaceutical manufacturers
The specifications are diverse - drug manufacturing is complex and highly regulated. Our service consists of close cooperation between the pharmaceutical industry. Together with the respective manufacturer, we work out the best solution together. Rattpack® - One-Stop-Shop for the pharmaceutical industry.
Questions that patients often ask in the area of medicines, medicines & package leaflets, package leaflets:
What does the package leaflet say?
What else can you call an instruction leaflet?
What does the package insert say?
Should you read package inserts?
We will be happy to answer these questions in a personal conversation. Let's talk on the phone!