Gaviscon Infant

Product Information *

  • Company:

    Reckitt Benckiser Ireland Limited
  • Status:

    No Recent Update
  • Active Ingredients * :

    *Additional information is available upon request

  • Legal Category:

    Supply through pharmacy only

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 29 May 2020

Reasons for updating

  • Change to section 2 - excipient warnings

Updated on 24 March 2020

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Addition of excipient warnings

Updated on 15 January 2020

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 25 April 2016

Reasons for updating

  • New PIL for new product

Updated on 25 April 2016

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to dosage and administration

Updated on 15 March 2016

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 15 March 2016

Reasons for 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

4.2 - Added ages of 1-2 years for both bottle fed infants and breast-fed infants in posology$04.4- Formatting update $0$04.6 - Formatting update $0$04.8 - updated formatting and updated information on how to report a side effect $0$04.9- addition of management of overdose $0$05.1- added pharmacotherapeutic group and ATC code $0

Updated on 03 March 2014

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 4.4 - added precautionary statement on constipation
In section 4.8 - added how to report a side effect
In section 10 - updated date of revision of the text

Updated on 19 February 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 06 December 2011

Reasons for updating

  • Change due to user-testing of patient information

Updated on 25 November 2011

Reasons for updating

  • Change to section 4.3 - Contraindications

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Included the following in section 4.3:

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1

Updated on 23 October 2007

Reasons for updating

  • New PIL for medicines.ie

Updated on 15 May 2007

Reasons for updating

  • Change to marketing authorisation holder address
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 1.  Name of Medicinal Product has been changed to Gaviscon Infant, Powder for Oral Suspension
 
Section 2.  Qualitative and Quantitative Composition has been expanded to state that each dose contains 21mg sodium.
 
Section 3. Pharmaceutical Form has been amended to read 'Powder for Oral Suspension'.
 
Section 7.  Address of marketing authorisation holder has been changed to: 7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Updated on 10 August 2004

Reasons for updating

  • Improved electronic presentation

Legal category:Supply through pharmacy only

Updated on 24 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through pharmacy only

Updated on 16 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through pharmacy only