Reporting a side effect
All medications have side effects and must have a package leaflet. A side effect is an unwanted or medical incident in a patient receiving treatment with a medication or medical preparation that is not necessarily related to the treatment. The most common side effects are already known from clinical studies. We only discover certain side effects after many different people take a medication. Side effects may occur only after long-term use of the medication. And sometimes side effects occur when a medication is used in combination with other medications.
Dietary supplements are covered by food legislation because these are legally considered food. For dietary supplements, package leaflets are not required. Nevertheless, unwanted reactions may also occur.
The importance of reporting a side effect
Qualiphar monitors medication safety by collecting and investigating all spontaneous reports from patients or care providers. We also have a statutory duty to collect and anonymise all details in an international database. All countries collect information on medication side effects in this international database. As a pharmaceutical company, we are regularly audited by the Federal Agency for Medicines and Health Products (FAMHP). This means we must always report your side effect.
How do I report a side effect?
To help us process your information quickly and effectively, please submit as much relevant information as possible using the form below. You should provide at least the following information:
- The contact details of the person making the report.
- The initials of the person who experienced the possible side effect and/or other personal details, such as gender and date of birth.
- The name of Qualiphar’s medication or product.
- A description of the possible side effect, such as the symptoms experienced, the date when the possible side effect first occurred and the outcome of the possible side effect.
What happens to your report?
- Our colleagues in the pharmacovigilance department collect, record, and analyse each individual report.
- When a side effect is reported, Qualiphar may collect certain personal data. You can find more information on this in the privacy policy. Every side effect is uploaded into the international database and reviewed there by the authorities.
- Experts evaluate those side effects so that action can be taken where necessary, for example by adjusting the package leaflet or alerting care providers.
If you have any questions about side effects of Qualiphar products, you are welcome to contact Qualiphar directly. You may also report the side effect directly to the Federal Agency for Medicines and Health Products (FAMHP) by visiting www.eenbijwerkingmelden.be.