ASK THE PHARMACIST | What are the ‘leaflets’ that come with medication, and should I read them?

According to law, certain information must be made available with each medicine in the form of a package insert or leaflet to ensure the safe and effective use of the medicine under most circumstances.

This document is approved by the South African Health Products Regulatory Authority (Sahpra) when the medicine is registered and no changes can be made without its approval.

There are two leaflets. The PI (professional information) is technical and scientific and aimed at the healthcare professional. The PIL (patient information leaflet) is worded in a way that is readily understood by the patient and the parent or guardian. Often, these two documents are combined in one, so make sure when you read your medicine leaflet that you are looking at the PIL, and not getting bogged down by the technical language of the PI.

The leaflets are either inside the medicine’s box or container or attached to the back of the label. Ask your pharmacist to give you the medicine leaflet if the medication has been repacked or if it is not included in the package.

In future we will increasingly see QR codes on the medicine label for scanning. Electronic product information, also called ePI, was recently adopted for medicines in the European Union, but this is new in South Africa. The digitised PI ensures quick access, is easier to read than the generally small font on the printed version and can be easily updated. It helps to reduce the number of printed inserts required, thereby preserving natural resources.

A leaflet contains very specific information and follows a standard format for every medicine. It includes the product name, the ailment or condition for which the medicine is used, the dosage and directions for use, possible side effects and interactions with other medicines and certain health conditions instructions on how to store the medicine, and a description of the contents of the pack. It also includes important safety information, such as whether the medication may impact you while driving or operating machinery, how it is influenced by food and drink, and whether it may negatively affect pregnancy, breastfeeding and fertility.

Side effects are listed according to severity and frequency. Not all side effects are included in the leaflet and you will not necessarily experience any of the side effects listed, including those termed frequent or common. If your general health worsens or you experience troubling effects, you should consult your doctor or pharmacist. You can also report suspected side effects online to Sahpra. Reporting side effects is important as it allows continued monitoring of the benefit versus the risk of the medicine.

Don’t throw your medicine leaflet in the bin. Read it and keep it because it contains important, trustworthy information aimed at the patient. Even if it seems too technical for you, you might learn something new about your ailment or your medicine.

Ask your doctor, pharmacist or other trusted healthcare provider if you have questions after reading your medicine leaflet.

* Thealdi Mitchell is a qualified registered pharmacist (B.Pharm) and managing editor of MIMS, a leading South African medical reference publisher owned by Arena Holdings (Pty) Ltd. She has experience in retail and hospital pharmacy, manufacturing and the medical aid industry. She believes in a holistic approach to health and taking small, daily steps to make better choices in self-care.

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