The fact that package inserts are so complicated is due to legal requirements. These lead to texts that hardly any patient understands. This means that the package inserts miss their real purpose.
So don’t doubt your intelligence if you have struggled through the package insert of a medication but still haven’t understood everything. Instead, ask your doctor or pharmacist for an explanation.
First understand, then swallow
Since January 1, 1999, pharmacies have also been required to have a separate consultation area where customers can receive confidential advice. The fact that the instructions for the patient and the medical information for the doctor are often described together on the package insert tends to obfuscate rather than provide clarity. The background to this is that manufacturers want to protect themselves from later claims for damages.
Package insert – what is particularly important
The following aspects are particularly important when reading the package insert:
” Contraindications (contraindications): Absolute contraindications are all circumstances that prohibit the use of the drug in question because of too serious side effects (e.g. pregnancy, asthma, stomach ulcers). In addition, there are relative contraindications, where the physician must weigh the benefits and risks of the drug application for the patient.
“Interactions with other agents (drug-drug interactions): Different medications can influence each other’s effects when used in close proximity to each other. You should by no means underestimate such interactions: The effect of one or both drugs can be reduced or increased, and in addition, a preparation can have a shorter or longer effect than it should.
However, not only other medicines, but also foods and stimulants can interact undesirably with a medicine. Therefore, avoid coffee, alcohol, grapefruit juice or dairy products if this is stated in the package insert or recommended by your doctor or pharmacist.
Side effects – don’t panic
Package inserts often contain a long list of possible side effects. The frequency with which the side effects can occur ranges from very common to very rare.
Pharmaceutical manufacturers must list all known side effects, even if they have only occurred in a single patient, for example. In addition, it is very unlikely that a patient will get all the side effects listed.
- Very rare: in less than 0.01 percent of cases
- Rare: in 0.01 to 0.1 percent
- Occasionally: 0.1 to 1 percent
- Frequently: in 1 to 10 percent
- Very often: in more than 10 percent
Don’t be put off by any package inserts, even if some read like a pathologist’s diary.
