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Medicines Authority

Awtorità dwar il-Mediċini



 

 

Know what is 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).

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.  Package leaflets have the same format and therefore the information is consistent for all products.  To improve package leaflets, new products are authorised only after the leaflet is tested on potential patients such that it is made as user-friendly as possible.  Once the text is approved by the Medicines Authority, the leaflets are published on http://www.medicinesauthority.gov.mt/products/search.htm