How To Understand The Package Insert Of A Medicine?

A medication package insert is the written information that accompanies the medication on its packaging. It is intended for the patient and provides all information about the characteristics of the drug.

Therefore, it is convenient to keep the package insert with the medicine, so that you can read it when you have any questions. All this information is intended for the correct use of the medicine and compliance with the prescribed treatment.

What information appears on a medicine’s package insert?

The package insert provides the necessary information for its therapeutic application, such as indications, dosage, precautions, contraindications, adverse reactions or use under special conditions.

Likewise, its possible side effects, interactions and contraindications are specified in a drug’s package insert. A summary of clinical data, pharmacological properties or preclinical safety data is also presented.

1. Composition

The first section of a medicine’s package insert informs about the active substances and the excipients that compose it. It indicates the name of the drugs, the quantity in which they are found and their presentation.

Active substances are therapeutically active, whereas excipients are not pharmacologically active. It is mandatory to include excipients in the package inserts, as they can cause allergies or intolerances in some people.

2. What is the medicine and what is it used for?

This section contains information about the pharmaceutical form in which the medicine is presented, as well as what it looks like.

It also explains in detail the therapeutic group to which the active substance belongs and the way it acts in our body. In addition, it also explains the diseases for which it has been studied and for which its use is approved.

3. What you should know before taking a drug

Not everyone can use the same medications. For this reason, it may be necessary to take certain precautions or make special adjustments, depending on your case.

In this section, a number of situations that must be taken into account before using the drug are specified. For this reason, on the package insert of a drug, you will find the following points :

• “Do not take if” : all cases where the drug should not be used are listed here.
• “Take special care if” : special warnings and precautions for employment are given at this time.
• Use with food and drink : This specifies whether the drug can be taken with or without food, and also specifies whether you can drink alcoholic beverages.
• Pregnancy : recommendations for use in case of pregnancy are detailed here.
• Lactation : recommendations are given for use in breastfeeding women.
• Driving and using machines : it is detailed whether the use of the drug can affect the ability to drive vehicles or operate machinery.

• Use with other drugs : interactions are produced by the simultaneous administration of one drug with others. This can cause an increase or decrease in the effect of any of the medications administered.

4. Dosage in the package insert of a drug

This section of a drug’s package insert indicates the dose to be administered according to the purpose for which it is to be used. Although it seems to you that this dose will have little effect or more than necessary, do not change it without first consulting your doctor.

There are medications for which it is necessary to adjust the dose, as they must be used by the elderly or children. It may also be necessary to adjust the dose in people with kidney or liver problems.

This section contains information on how to take it, as well as information you need if you take more than you should or if you miss a dose.

5. Adverse reactions

The most common is that no side effects are manifested and, if any, appear mildly. However, if an undesirable effect or reaction appears, contact your doctor.

6. Preservation of the drug

This section of a drug package insert details the storage conditions under which each drug should be kept. It is important to maintain the recommended temperature and humidity conditions so that they maintain their validity.

Conclusion on the package insert of a drug

Reading the package insert for a drug is important, because that way, we will have all the necessary information in writing. But remember, consult your doctor or pharmacist if in doubt. And most importantly, don’t self-medicate.