Reporting side effects
What is a side effect ?
A side effect of a medicine is an unexpected symptom caused by a treatment after administration that occurs in addition to the intended effect. They're also called adverse effects or adverse reactions.
Any medication (prescription medicines or OTC, medicines you can buy over the counter), cosmetics, food supplements (herbal remedies and supplements) or medical devices can cause unwanted effects, which are often secondary to the beneficial effects of the treatment. These side effects can be the result of the medicine itself, certain characteristics of the patient such as hypersensitivity or allergy, misuse of a medicine or a combination with other substances.
The side effects of a medication are described in the package leaflet/notice. Side effects can range from mild to more severe symptoms. The risk of getting side effects varies from person to person. Not everyone experiences the side effects of medicines equally: some people do not even suffer from them at all.
Contact your GP if you think that you may be having a serious adverse reaction to a medicine, cosmetic, food supplement or medical device. In some cases, treatment adjustments should be considered.
Why report ?
During the different phases of the scientific research, researchers identify the most common and predictable side effects. Once a drug is placed on the market, it is no longer used under the test environment of scientific research. Millions of patients from different age groups, with different lifestyles and sometimes with different conditions will use it every day.
Some side effects may also only occur with long-term use of a medicine, whether in combination with various other medicines or even after stopping a treatment.
It is therefore important to continuously monitor the safety of a medicine after it was placed on the market. Reporting side effects plays a crucial role in this.
The registration and analysis of data on side effects of medicines provides knowledge that is important for healthcare providers and patients in the choice of a medicine, the possible prevention, and the timely recognition of side effects. The timely identification of side effects is important so that adequate medical action can be taken because knowledge about side effects also plays a crucial role in the prescription of medicines.
We at Arega are committed to the safety and wellbeing of our patients and healthcare professionals and prioritize safe use of medicines and therefore encourage everybody to report any information regarding the safety, quality, or performance of our products.
How to report ?
If you are a healthcare professional with a patient who has experienced a suspected side effect with one of our products, you can report this to us by sending us the yellow forms or by contacting directly our pharmacovigilance department (email@example.com or +32 3 808 67 02 ) or by contacting the relevant authorities.
For patients we recommend contacting your health care provider to report us the side effect you experienced. But you can also report an event through the online form here below.
Note that any report will be processed anonymously and reported to the appropriate relevant authorities in accordance with current legislation.
Note for health care professionals
Are you a health care professional and do you want to report a side effect? Please consult the secured pages of the Arega HCP professional zone where you can download the yellow form or contact us by mail at firstname.lastname@example.org or call +32 3 808 67 02 (24/7).