Gaviscon Infant
*Company:
Reckitt Benckiser Ireland LimitedStatus:
No Recent UpdateLegal Category:
Supply through pharmacy onlyActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 29 May 2020
File name
Gaviscon Infant Leaflet.pdf
Reasons for updating
- Change to section 2 - excipient warnings
Updated on 24 March 2020
File name
Gaviscon Infant SmPC.pdf
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
File name
Gaviscon Infant.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 25 April 2016
File name
PIL_12572_394.pdf
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
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
Reckitt Benckiser Ireland Limited
Address:
7 Riverwalk, Citywest Business Campus, Dublin 24, IrelandTelephone:
+353 1 468 9200Fax:
+353 1 468 9299