Last Updated on eMC 06-07-2015 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 4.8 - Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:30-06-2015

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

section 4.8 - To update section to include the yellow card statement.

section 10 - Revision text date, 30 June 2015

Reasons for adding or updating:

  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • 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:20-02-2014

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 4.6: To add the following text
Pregnancy: There are no or limited amount of data from the use of Guaifenesin in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). Guaifenesin Cough Menthol Flavour 20mg/ml Oral Solution is not recommended during pregnancy and in women of childbearing potential not using contraception.

Breast-Feeding: Guaifenesin is excreted in breast milk in small amounts. There is insufficient information of the effects of Guaifenesin in newborn/infants. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Guaifenesin Cough Menthol Flavour 20mg/ml Oral Solution therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the women.

Fertility:
There is insufficient information available to determine whether guaifenesin has the potential to impair fertility.

In section 4.7: To add the following text
Guaifenesin has no or negligible influence on the ability to drive and use machines

In section 4.8: To add the following text
including, pruritus and urticaria, rash. Abdominal pain upper, diarrhoea

In section 4.9 to add the following text
When taken in excessm guaifenesin may cause renal calculi

In section 10: date of revision text 20 February 2014

Reasons for adding or updating:

  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-10-2012

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



In section 6.5
A plastic dosing cup marked with 10ml graduation may be included in this pack

In section 10 - Date of revision of the text
01 October 2012

Reasons for adding or updating:

  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • 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 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:24-01-2012

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Nature of change: Changes to SPC resulting from MRP procedure: changes to sections 1, 2, 3, 4.1, 4.4, 4.5, 4.6, 4.7, 4.8, 5.1, 6.1, 6.4 and 6.6

Reasons for adding or updating:

  • New SPC for new product

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

Legal Category:GSL

Black Triangle (CHM): NO