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What a patient information leaflet is and where to find the current…

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What a patient information leaflet is and where to find the current one

  • Explainers
  • The Dose Club team
  • Updated

Every pack of Wegovy and Mounjaro carries a leaflet approved by the MHRA. What its six sections cover, where the current version is published and how to tell when the wording has changed since your box was packed.

The folded sheet inside the box is the patient information leaflet. The Wegovy and Mounjaro leaflets open with the same instruction: "Read all of this leaflet carefully before you start using this medicine because it contains important information for you." This article explains what the leaflet is, how it is organised, where the current version is published and how to tell whether the copy in your box is out of date.

What the leaflet is

A patient information leaflet is the patient's version of the information the regulator approved when it licensed the medicine. In the UK the regulator is the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA's own product database describes it this way: "Every medicine pack includes a patient information leaflet (PIL), which provides information on using the medicine safely."

The leaflet sits beside a longer document written for healthcare professionals, the summary of product characteristics (SmPC). The MHRA describes the SmPC as a document that sets out "a medicinal product's properties and the conditions attached to its use". The two documents describe the same licence. The leaflet is the plain language version and the SmPC carries the detail a prescriber or pharmacist needs. Articles on this site quote both.

The six sections

The Wegovy and Mounjaro leaflets follow the same structure, which is the standard one for UK medicines. The Wegovy leaflet lists its contents as:

  1. What the medicine is and what it is used for
  2. What you need to know before you use it
  3. How to use it
  4. Possible side effects
  5. How to store it
  6. Contents of the pack and other information

Section 3 holds the instruction on when to use the medicine and what to do about a forgotten dose. Section 4 lists the side effects reported with the medicine and says which need urgent help. Section 5 gives the storage conditions. Section 6 lists the ingredients, describes the pack and names the marketing authorisation holder. The pen's instructions for use are either printed after the leaflet, as in the Wegovy document, or supplied as a separate sheet, which the Mounjaro leaflet refers to as the "Instructions for Use".

Both leaflets carry an inverted black triangle near the top with the words "This medicine is subject to additional monitoring." The MHRA's Yellow Card guidance explains that the triangle marks products "under additional monitoring" and adds: "It does not mean the medicine is unsafe." It asks that all suspected side effects for these products are reported.

Where the current version is published

Two public sources carry the current UK leaflet, and both are free and need no account.

The electronic medicines compendium (emc), at medicines.org.uk/emc, is run by Datapharm Ltd. It publishes the SmPC and the patient leaflet for medicines licensed in the UK, and it says every document on it has been "checked and approved by either the UK or European government agencies which license medicines". Companies are expected to update the emc within 10 days of the regulator approving a change. Each product page shows the date the document was last updated on the emc, and the leaflet itself ends with a line that reads "This leaflet was last revised in" followed by a month and year.

The MHRA Products website, at products.mhra.gov.uk, is the regulator's own database. It lets you search by medicine name, by the product licence (PL) number or by active substance, and it carries the leaflet, the SmPC and, for newer licences, the public assessment report that explains the regulator's decision.

Which leaflet applies to you

The leaflet in your box is the one that applied when the box was packed. The Wegovy and Mounjaro pens each have an emc entry per strength, so match the strength on your box to the entry you open. If the revision date online is later than the one in your box, the wording has changed since your medicine was dispensed, and the pharmacy that dispensed it can tell you what changed.

The Dose Club app links to the leaflet for your region from the missed dose screen and shows the leaflet's words, for the same reason this article points you to the source: the leaflet is the approved text, and it changes from time to time.

Sources

This article is information, not medical advice. Talk to your prescriber about your treatment.

  • leaflets
  • emc
  • MHRA