The importance of reading the package leaflet: know everything about the medicine

In every medicine box there is a “read the package insert” guidance, and there is a good reason for that. This leaflet contains all the important information for the knowledge of the drug, as well as its safe use.

And following the recommendation can make all the difference, especially to understand what the substance was indicated for, how it should be taken and what forms of action.

It is worth remembering that the package inserts that accompany the medication are those with language accessible to patients and lay people. That is, they are specially developed to clarify, in a simple way, everything that is necessary about the remedy.

But there is some other information about this reading and that can make it easier to understand the content:


What is the purpose of a package insert?

The purpose of the package insert is to provide clear and safe information, both for patients and professionals – remembering that, therefore, there are two types of package inserts. The one that comes with the medication is the one aimed at informing patients and lay people.

The package insert is a legal health document, and ANVISA indicates that it serves to assist patients in obtaining information and guidance on the medication, allowing the safe use of the substance and effective treatment. It should contain information such as:

  • How does this medicine work?
  • Why was this medicine indicated?
  • When should I not use this medicine?
  • How should I use this medicine?
  • What are the ills that this medicine can cause?
  • What to do if someone uses a large amount of this medicine at once?
  • Where and how should I store this medicine?

Every medicine has instructions for use! Even those that can be purchased in cartels, which usually come without. In this case, patients have the right to request the document at the pharmacy at the time of purchase.

Oh, and if you have lost or discarded the package insert, all you have to do is look for the document on ANVISA’s electronic dossier or on the Consulta Remédios portal. So, you can find all the information on the screen of your cell phone or computer.

What is the difference between the professional leaflet and that of the patient?

There are two types of package insert, professional and patient. The difference between them lies mainly in the language used . The package insert that comes with the drugs is that of patients and, therefore, is accessible for reading and understanding by lay people, organized in the form of questions and answers.

It has all the necessary information about the substance, mechanism of action, dosage and side effects. However, everything is written in a less technical way, so that it is easier to understand the important information.

According to RDC No. 47, of September 8, 2009, the topics present in the package insert for patients are:

  • What is this medicine for?
  • How does this medicine work?
  • When should I not use this medicine?
  • What should I know before using this medication?
  • Where, how and for how long can I store this medicine?
  • How should I use this medicine?
  • What should I do when I forget to use this medication?
  • What are the ills that this medication can cause me?
  • What to do if someone uses more than the recommended amount of this medicine?

According to ANVISA, the package insert for professionals has more technical terms and more complex information. However, it is worth noting that both contain the same content of information. In it, the topics present are:

  • Indications;
  • Efficiency results;
  • Pharmacological characteristics;
  • Contraindications;
  • Warnings and precautions;
  • Drug interactions;
  • Care of medicine storage;
  • Posology and method of use;
  • Adverse reactions;
  • Overdose.

Special package inserts

The package inserts also have inclusive resources, which facilitate access to information by people with some special need related to vision. There are three special types:

  • Bullets in audio or text, which can be processed by computer programs;
  • Bullets printed in Braille;
  • Bullets printed with larger letters (enlarged font).

If necessary, patients can contact the manufacturer’s Customer Service System (SAC) and request the desired special format. This request must be free of charge.

Why is it important to always read the package insert before taking any medicine?

The package insert provides information about the drug’s indications, forms of use, dosages and side effects. This, together with the other information contained in the document, is indispensable for the safe use of the medicine.

Many people do not read because they think it is not important, either because the medicine was prescribed by professionals or because they have been using it for some time. But in fact, the package insert has a lot of information that should be known.

With them, it is possible to predict reactions and even reduce risks – for example, sometimes the medication contains some substance that the person knows is allergic, but does not even suspect that it is in the composition. Or, still, it uses some other medicine or food that can cause drug interaction . This reduces risks through accessible information.

The package insert also lists the possible side effects. So, if any adverse symptoms arise, whoever is using the medication already knows if it is related to the treatment or not.

In addition, some substances need special storage care. And all this information is present in the document, making it safer to use.

How to read the instructions for a medicine?

Everything on the package insert is important to properly understand the action and indication of the medication. Therefore, the ideal is to read the document in its entirety, paying attention to the information contained therein.

In general, the package inserts can be divided into three axes: identification of the medication, information to the patient and legal guidelines.

Want to know how to understand what the document says? Know each axis:

Identification of the medicine

All that information related to the active ingredient, pharmaceutical form (for example, tablet, capsule, syrup, among others) and composition (excipients and active ingredient) are in that part. It brings important information to people who are allergic to a substance, for example.

Patient information

In this part, patients have access to information about the indication, how the medication acts, when it should not be used (in cases of pregnancy, for example), how to store it properly, how to use it (interval between doses, dosage) and adverse effects.

There are also indications on how to proceed if the dose is missed and what to do in cases of overdose.

Legal guidelines

In this last part, patients find information about the manufacturer and the address, responsible pharmacist and other legal information that may be needed.

For what types of medicine is the package insert required?

All medicines require package inserts, even those sold in cartons or flaconettes have package inserts available in pharmacies. For this reason, whenever buying a medicine, it is possible to request the document at the pharmacy or even search for it on the internet, on the official ANVISA website (electronic dossier), laboratory website or at Consulta Remédios.