Last Updated on eMC 01-11-2016 View medicine  | Leo Laboratories Limited Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Reasons for adding or updating:

  • Correction of spelling/typing errors

Reasons for adding or updating:

  • Change to section 2 - excipient warnings

Reasons for adding or updating:

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children/adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Reasons for adding or updating:

  • Change to section 6 - marketing authorisation holder

Reasons for adding or updating:

  • Change to drug interactions

Reasons for adding or updating:

  • Removal of one or more presentations from joint PIL following discontinuation

Reasons for adding or updating:

  • Change to, or new, use for medicine
  • Change to dosage and administration

Reasons for adding or updating:

  • Improved Electronic Presentation

Reasons for adding or updating:

  • Change due to user-testing of patient information

Reasons for adding or updating:

  • Transfer to upgraded management system

Reasons for adding or updating:

  • Change to warnings or special precautions for use
  • Change of contra-indications
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision
  • Change to information about pregnancy or lactation

Reasons for adding or updating:

  • Update to PIL

Reasons for adding or updating:

  • Update to PIL