Before being released on the market, a medicine has to go through a series of research which would examine its safeness. If significant side effects are discovered in time, the medicine is rejected. However, some side effects are noticed only when the medicine is already on the market, so keeping track and recording them is important to keep the safety of patients.

Side effects

According to Agency for medicines and medical products (cro. Agencija za lijekove i medicinske proizvode, HALMED), a side effect is every harmful and unwanted reaction to the medicine. The occurrence of side effects is greatly impacted by patient’s age, gender, ethnicity, existing diseases, genetical predispositions and geographical factors. It is also impacted by type of medicine, way of administration, duration of therapy, strength of the dose and bioavailability.

Division of side effects

Side effects can be divided in three main groups. They are divided by dose, allergic reactions and idiosyncratic side effects.

Dose-dependent side effects can be noticed when an overly high dose is administered, when the medicine is residing in the system longer than it should because of the interaction with other medications etc. Such side effects are often predictable, rarely serious and most common.

When an allergic reaction occurs, the immune system is activated, and it is often manifested as rash and itch, high fever, narrowing of the airways accompanied by hard breathing, tissue swelling and blood pressure drop. It is important that the patient knows which medicine they had an allergic reaction to, so that future allergic reactions can be prevented.

Genetic diversity of the people can lead to idiosyncratic side effects. They are rare and unpredictable, harder to cope with and their cause is not known.

What to do if we notice side effects?

Side effects can be unavoidable and unpredictable, but they surely impact the patient’s life quality. They can impact the patient’s health too. In a year, 8% of the hospitalizations are due to side effects of the medications.

HALMED’s internet site lists steps that should be taken if side effects are noticed.

1. Read the medicine’s instructions again

Some of the side effects of a certain medication are already recorded and listed in the Instructions for the medication. There is a variation of severity of the side effects and the guidelines on what to do if they are noticed are listed in the Instructions.

2. Talk to a doctor or a pharmacist

Doctors and pharmacists are professional medical staff who are familiar with the the way a certain medication works and with possible side effects. They will give advice on what to do next (for example, they will lover the dose, cease the therapy or give a substitute therapy etc.)

3. It is also possible to personally report the side effect via the online app for side effects report or directly to HALMED via the Patient/Medication User Side Effect Reporting Form.

What else can I do?

When mild side effects (such as constipation, diarrhea, dizziness, dry mouth, headaches, loss of appetite, insomnia etc.) occur, it is necessary to avoid the activities that might intensify them. For example, it is advised that the patients who experience insomnia avoid drinks which contain caffein, nicotine products and alcohol. Exercise and intense physical activity may prolong the wake time and delay sleep. For the patience who experience constipation, it is advised to ingest food rich with fibers, drinking a lot of liquid and physical activity.

In case the side effects do not stop or intensify, it is necessary to immediately contact your doctor or your pharmacist.

Translated by Lea Malezan