Last Updated on eMC 01-09-2014 View medicine  | Concordia International - formerly AMCo 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:

  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:20-08-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

    Section 4.7:Effects on Ability to Drive and Use Machines
    Addition of following information:

This medicine can impair cognitive function and can affect a patient’s ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients should be told:

·         The medicine is likely to affect your ability to drive

·         Do not drive until you know how the medicine affects you

·         It is an offence to drive while under the influence of this medicine

·         However, you would not be committing an offence (called ‘statutory defence’) if:

o   The medicine has been prescribed to treat a medical or dental problem and

o   You have taken it according to the instructions given by the prescriber and in the information provided with the medicine and

o   It was not affecting your ability to drive safely



Reasons for adding or updating:

  • Change to section 7 - Marketing authorisation holder

Date of revision of text on the SPC:12-09-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 7 of Marketing Authorisation Holder has been changed from Antigen International Ltd to Mercury Pharma International Ltd.

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Date of revision of text on the SPC:01-01-0001

Legal Category:POM

Black Triangle (CHM): NO