Last Updated on eMC 03-03-2016 View medicine  | McNeil Products 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 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:26-02-2016

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 6.1 Added following excipients to Film Coating "Hypromellose" "Indigo Carmine (E132)" "Titanium Dioxide (E171)"

Removed following excipients from Film Coating "Methocel E5 (E5 Premium)" "Opaspray M 1F 4315B"

Section 10 Replaced date with "26 February 2016"

Reasons for adding or updating:

  • Change to section 1 -Name of the Medicinal product
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:27-05-2010

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Change: Variation to add an alternative name Sudafed Decongestant & Pain Tablets to the Benylin Day & Night Tablets licence.

Chnages to sections 1 (Name of the medicinal product), 4.4 (Special warnings and precautions for use), 4.5 (Interaction with other medicinal products and other forms of interaction) & 4.6 (Pregnancy and lactation) of the SPC.

Reasons for adding or updating:

  • Change to section 6. 5 - Nature and Contents of Container

Date of revision of text on the SPC:30-04-2009

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Minor change to SPC section 6.5 (Container type)

Reasons for adding or updating:

  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:07-01-2009

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Licence renewal (change to date of renewal and date of revision of text)

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder

Date of revision of text on the SPC:01-03-2008

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Change to MA as a result of integration

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition

Date of revision of text on the SPC:01-10-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

To replace the currently registered pack size of 20 tablets (15 day and 5 night tablets) with a pack size of 16 tablets (12 day and 4 night tablets).

Reasons for adding or updating:

  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-10-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 10: Change of the date of the revision of the text

Reasons for adding or updating:

  • Change to section 10 (date of (partial) revision of the text

Reasons for adding or updating:

  • Change to section 10 (date of (partial) revision of the text

Reasons for adding or updating:

  • Change to section 10 (date of (partial) revision of the text

Reasons for adding or updating:

  • Change to section 10 (date of (partial) revision of the text

Reasons for adding or updating:

  • Change to section 10 (date of (partial) revision of the text

Reasons for adding or updating:

  • Change to section 10 (date of (partial) revision of the text

Reasons for adding or updating:

  • Correction of spelling/typing errors

Reasons for adding or updating:

  • Improved Electronic Presentation

Reasons for adding or updating:

  • Change to section 2 - qualitative and quantitative composition

Reasons for adding or updating:

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