Gaviscon Advance Oral Suspension
*Company:
Reckitt Benckiser Ireland LimitedStatus:
UpdatedLegal Category:
Supply through pharmacy onlyActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 18 April 2024
File name
Gaviscon Advance SmPC.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
Legal category:Supply through pharmacy only
Updated on 18 April 2024
File name
Gavi Advance OS Aniseed Label_PIL (Name change) Feb23.pdf
Reasons for updating
- Change to name of medicinal product
Updated on 11 April 2022
File name
GAVISC~3.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - excipient warnings
- Change to section 6 - what the product contains
Updated on 11 April 2022
File name
Gaviscon Advance Label.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - what the product contains
Updated on 11 April 2022
File name
Gaviscon Advance SmPC.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Supply through pharmacy only
Updated on 14 October 2020
File name
Gaviscon Advance Oral Suspension PIL July 20.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 20 August 2020
File name
Gaviscon Advance Oral Suspension July20.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Supply through pharmacy only
Updated on 15 January 2020
File name
Gaviscon Advance Oral Suspension.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 21 July 2015
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Updated on 21 July 2015
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- 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 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updates made to SmPC to align with current company safety information
Updated on 20 July 2015
File name
PIL_15986_504.pdf
Reasons for updating
- New PIL for new product
Updated on 20 July 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to further information section
- Change to date of revision
Updated on 31 July 2014
Reasons for updating
- Change to packaging
Updated on 16 April 2014
Reasons for updating
- New PIL for medicines.ie
Updated on 29 March 2011
Reasons for updating
- 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
10 Date of revision of the text
amended from July 2009 to September 2009 (to relfect that of schedule)
amended from July 2009 to September 2009 (to relfect that of schedule)
Updated on 03 September 2009
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 4.7 - Effects on ability to drive and use machines
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- 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
- Section 2: Dosage per 5ml and 1ml added
- Section 4.2: Extra instructions added, If symptoms do not improve...
- Section 4.4: Statement deleted, If symptoms do not improve...
- Section 4.6: Delete statement about limiting treatment
- Section 4.7:statement updated
- Section 5.2: PK properties updated
- Section 6.1:Sodium Hydroxide (for pH adjustment)
- Section 6.5: nature of container contents updated
- Section 6.6: waste diposal istructions added
Updated on 15 May 2007
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- Change to section 4.3 - Contraindications
- Change to section 4.6 - Pregnancy and lactation
- Change to section 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to marketing authorisation holder address
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
SECTION 1. Name of medicinal product changed to Gaviscon Advance Oral Suspension.
SECTION 2. Excipients: methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) added to this section.
SECTION 4.1. Wording of therapeutic indications modified.
SECTION 4.3 Contraindications wording modified.
SECTION 4.6. Additional recommendation added to pregnancy and lactation section to limit treatment duration as much as possible due to presence of calcium carbonate.
SECTION 6.1. Ingredients of fennel flavour added: fennel anethol and benzyl alcohol.
SECTION 6.3 Shelf life after opening extended to 6 months.
SECTION 7. Change of address of marketing authorisation holder to: 7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Updated on 30 June 2005
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 10 August 2004
Reasons for updating
- Improved electronic presentation
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