Medication Package Inserts - How to Read Them

18 February, 2020
The dosage section of medication package inserts usually lists the dose to administer according to its purpose. Sometimes it may seem like a certain drug isn't doing anything or, on the contrary, is doing too much. However, don't ever change the prescribed dose without consulting with your doctor.

Medication package inserts contain written information about the drugs they come with. They’re aimed at patients and provide information about the characteristics of specific drugs.

It’s always a good idea to keep the package inserts with the actual medication so you can refer to them if any doubts arise. This purpose of kind of information is to aid patients in the correct use of their medication and compliance with the prescribed treatment.

The information on medication package inserts

An array of pill blisters.

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

They also include the chemical composition of medications and instructions for their administration, use, and proper storage.

Likewise, these leaflets also specify any possible side effects, interactions, and contraindications. In addition, they contain a summary of the clinical data, pharmacological properties, and preclinical safety data.

1. Description

The first section of a medication package insert informs about a drug’s active substances and their composition. It tells you the name of the substances, the amount it contains and their different formats.

The active substances are for therapeutic purposes, while the inactive substances are self-descriptive. Pharmaceutical companies must list said substances in the leaflets as some can lead to allergies or intolerance in some people.

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2. Purpose of medication package inserts

This section contains information on the pharmaceutical format of the medication.

It also explains the therapeutic group to which the active substance belongs and its effect on the human body. In addition, it lists the diseases it intends to treat and which ones it’s approved for.

3. Before you start treatment with a medication

A pharmacist telling a man how to read medication package inserts.

Certain medications aren’t suitable for everyone. For this reason, it may be necessary to take some precautions or make special adjustments, depending on the case.

Within this section, pharmaceutical companies specify a series of situations a patient must take into account before using that particular medication. Thus, medication package inserts will list the following:

  • In this section, you’ll find all the cases in which you shouldn’t use this medication.
  • You’ll also find special warnings and precautions here such as their use with certain food and drinks. That is, whether you should take it with food or on an empty stomach and also whether you can drink alcoholic beverages or not.
  • In addition, you’ll find recommendations for its use. In cases of pregnancy, for example.
  • Also, it contains recommendations for its use by nursing women.
  • The medication package inserts also detail if the use of that particular drug can affect a person’s ability to drive vehicles or operate machinery.
  • This section will also detail a drug’s interactions with other drugs. That is, what effects a person can expect after its simultaneous administration with other medications. This is important because it may enhance or cancel the effect of one of the drugs.

4. Posology

This section of the medication package inserts details the dose to administer according to the purpose for which a patient is going to use it. Even though it may seem like a certain drug has little to no effect or you’re getting really high from it, don’t change the dose without consulting your doctor.

There are medications for which an MD may have to adjust the dose, especially when prescribed to older people or to children. Doctors may also adjust the dose in people with kidney or liver problems.

This section contains information on how to take it, as well as necessary information for those times when you might take more than you should or when you happen to miss a dose.

5. Adverse reactions

A doctors giving instructions to a customer.

All medications can lead to side effects and adverse reactions. This part of the leaflet informs you of any unwanted reactions that a certain drug can produce in your body.

Note that most drugs have no side effects, and they’re mild when they do appear. However, you should contact your doctor if there’s an undesirable effect or reaction.

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6. Preservation of the medicine

This section of a medication package inserts details of the storage conditions. It’s important to do so at the recommended temperature and humidity conditions.

Conclusion on the medication package inserts

Reading this kind of leaflet is important because it contains all the information you need. However, you must always consult your doctor or pharmacist if you have any doubts. And most importantly, never, ever self-medicate.

  • Cerviño López, M. (2010). Farmacovigilancia. Albéitar: Publicación Veterinaria Independiente.

  • Rojas, C. B. (2001). Fases del desarrollo de un nuevo medicamento. Estrategias de Investigación En Medicina Clínica. El Manual Moderno.

  • Aguilar, N. G., & Girón Aguilar Nora, D. R. (2010). Sistema de distribución de medicamentos por dosis unitarias Elaborado por : Honduras OPS / OMS Rosario D´Alessio Asesora Regional en Servicios Farmacéuticos OPS / OMS Octubre 1997. Serie Medicamentos Esenciales Y Tecnologia. https://doi.org/10.1101/093575