Last Updated on eMC 06-07-2016 View medicine  | GlaxoSmithKline Consumer Healthcare 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 8 - Marketing authorisation number(s)
  • Change to section 7 - Marketing authorisation holder

Date of revision of text on the SPC:02-11-2015

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Change to the SPC following the Change of Ownership

Reasons for adding or updating:

  • Correction of spelling/typing errors

Date of revision of text on the SPC:14-10-2011

Legal Category:P

Black Triangle (CHM): NO

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration

Date of revision of text on the SPC:14-10-2011

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.2 - Maximum duration of use amended to 5 days.

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-07-2010

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.3 – Contra-indications to concomitant use of other sympathomimetic decongestants, phaeochromosytoma and closed angle glaucoma added.

Section 4.4 – Special warnings and precautions added for enlarged prostate gland, occlusive vascular disease and cardiovascular disease.  Addition of advice to consult a physician before taking if suffering from chronic cough or asthma, or if cough lasts more than 5 days, comes back, or is accompanied by a fever, rash or persistent headache.

Section 4.5 – Addition of table detailing nature of drug interactions.

Section 4.8 – Addition of table listing undesirable effects by ingredient and body system.

Section 4.9 – Revision of section relating to phenylephrine and addition of section relating to guaifenesin.

Section 10  - New revision date

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:P

Black Triangle (CHM): NO