Last Updated on eMC 15-03-2016 View medicine  | Thornton & Ross Ltd 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 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:10-03-2016

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 4.2 - update to guidance re: duration of treatment (no change to maximum duration)
In section 4.4 - addition of warning regarding risk of renal impairment in dehydrated children

Reasons for adding or updating:

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects

Date of revision of text on the SPC:20-01-2016

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 4.2 - addition of lowest effective dose guidance
In section 4.3 - Addition of "(NYHA Class IV)"
In section 4.4 - Update of Cardiovascular and cerebrovascular effects wording in-line with EMA/217862/2015
In section 4.5 - Rewording of section regarding Acetylsalicylic acid (Aspirin) & addition of hyperkalaemia warning when used in combination with antihypertensives/diuretics
In section 4.8 - Update of Cardiovascular and cerebrovascular effects wording in-line with EMA/217862/2015
In section 4.9 - Addition of hyperkalaemia warning
In section 5.1 - Rewording of section regarding Acetylsalicylic acid (Aspirin)

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:09-03-2015

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 4.8, MHRA wording on reporting of suspected adverse reactions has been added.

Reasons for adding or updating:

  • Change to section 1 - Name of the medicinal product

Date of revision of text on the SPC:29-09-2010

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 1 - Removal of non-marketed name

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:GSL

Black Triangle (CHM): NO