Every medicine has not only beneficial, expected and desired effects, but also unwanted effects. Although the safety of medicines is thoroughly assessed before they are granted marketing authorisation, some adverse effects (particularly very rare ones) and certain interactions can only be identified once a medicine is on the market and in use. This may be due to genetic factors, longer treatment periods than those studied in clinical trials, population-related factors and other circumstances.
Under medicines legislation, an adverse drug reaction is any harmful and unintended response to a medicine that occurs at doses normally used for the treatment or prevention of disease, for diagnosis, or for the restoration, improvement or modification of physiological functions. Adverse drug reactions are relatively common, but only a small proportion are serious and potentially life-threatening.
What should you do if you experience an adverse drug reaction or suspect that you may be experiencing one?
If you suspect an adverse drug reaction, do not stop your treatment on your own, as the reaction may be temporary.
Read the package leaflet. The section entitled Possible side effects lists adverse reactions reported in connection with the medicine. Check whether your symptoms could be related to the medicine.
Inform your doctor or pharmacist, and together you can find an appropriate solution.
You can also report suspected adverse drug reactions to your community pharmacist at any time. Carefully documenting and reporting adverse drug reactions helps identify all possible reactions, establish how frequently they occur and detect previously unknown adverse effects. By doing so, you can contribute to the accurate recording of potential adverse effects and to raising awareness of them in the future.
Every report submitted by a patient, healthcare professional or caregiver plays a vital role in improving our understanding of the benefits and risks of medicines used in clinical practice. Where necessary, such reports can also prompt action to reduce risks.
Important to know!
Most common adverse drug reactions are mild and usually occur temporarily when treatment is first started. If you suspect an adverse drug reaction, do not stop your treatment on your own. Consult your doctor or pharmacist. You can report suspected adverse drug reactions to your pharmacist at your local pharmacy.
Slovenia has an established system for reporting adverse drug reactions, involving both healthcare professionals and patients. By reporting suspected adverse drug reactions, you provide valuable information that helps identify so-called safety signals and assess the benefit-risk balance of medicines. Every report of a suspected adverse drug reaction is therefore important and can contribute to the safer use of medicines.
Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
Pharmacovigilance Department
National Pharmacovigilance Centre
Slovenčeva ulica 22
SI-1000 Ljubljana
Fax: +386 (0)8 2000 510
Email: h-farmakovigilanca@jazmp.si
Tel.: +386 (0)8 2000 500