What is the Package Leaflet?

Introduction

All medicinal products placed on the local market are required by EU Community law to be accompanied by labelling and a package leaflet (unless all the information can be shown on the label) which provides comprehensive information enabling the safe and appropriate use of the medicinal product.

Information in the Package Leaflet

The package leaflet contains information on, among other things: 

  • what the medicinal product is for;
  • how much of the product must be taken and how often;
  • when the product must not be used;
  • warnings and precautions for use;
  • what side-effects may occur;
  • contact of the Marketing Authorisation Holder (company responsible for placing the product on the market);
  • how to store the medicinal product

 

It is therefore important that patients always read the package leaflet carefully before using a medicinal product. The package leaflet, together with the information given by the doctor and pharmacist, is an important source of information for the best and safest use of the medicinal product.

The package leaflet should be easily legible, clearly comprehensible and indelible.  In fact, every so often, the package leaflet is subjected to consultations with target patient groups to ensure that the contents are legible, clear and easy to use.  This is also known as 'readability patient/user testing'.

Authorisation of Package Leaflet

The Medicines Authority ensures that the leaflets are up to date with any changes or variations to the product information that may take place after the product has been placed on the market.  The relevant information is taken from the Summary of Product Characteristics (a document which forms the basis of prescribing information for healthcare professionals).

Finding Package Leaflets

Package Leaflets and Summary of Product Characteristics of medicinal products authorised in Malta can be found through the Search for Medicines Function.