Gaviscon Suspension
*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 16 September 2024
File name
Gaviscon Oral Suspension PIL May 21.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 18 April 2024
File name
RBL2304428 MIssing EAN Barcode Update CURRENT LABELING.pdf
Reasons for updating
- New PIL for medicines.ie
Updated on 14 September 2021
File name
Gaviscon Oral Suspension PIL.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 13 May 2021
File name
Gaviscon Oral Suspension SmPC May21.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 - how to report a side effect
Legal category:Supply through pharmacy only
Updated on 15 January 2020
File name
Gaviscon Oral Susp Aniseed flavour.pdf
Reasons for updating
- New PIL for new product
Updated on 20 April 2016
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Updated on 20 April 2016
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Section 6.4 - 100ml bottle size has been deleted
Updated on 20 April 2016
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Free text change information supplied by the pharmaceutical company
Section 6.4 - 100ml bottle size has been deleted
Updated on 17 April 2014
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 4.5 - 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 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Section 4.2 - added Children under 12 should only be given on medical advice, added information for special patient groups
Section 4.3 - added contraindication for hypersensitivity to active ingredients and excipients
Section 4.4 - added statement regarding calcium and statement to limit treatment duration as much as possible
Section 4.5 - added a 2 hour time interval between taking Gaviscon and other specified products
Section 4.6 - added more detailed information on taking Gaviscon for Pregnancy, breastfeeding, and fertility
Section 4.7 - Updated wording
Section 4.8 - updated frequencies
Section 5.1 - added pharmacotherapeutic group
Section 10 - Changed Date of revision of text
Section 4.3 - added contraindication for hypersensitivity to active ingredients and excipients
Section 4.4 - added statement regarding calcium and statement to limit treatment duration as much as possible
Section 4.5 - added a 2 hour time interval between taking Gaviscon and other specified products
Section 4.6 - added more detailed information on taking Gaviscon for Pregnancy, breastfeeding, and fertility
Section 4.7 - Updated wording
Section 4.8 - updated frequencies
Section 5.1 - added pharmacotherapeutic group
Section 10 - Changed Date of revision of text
Updated on 17 April 2014
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 4.5 - 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 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Section 4.2 - added Children under 12 should only be given on medical advice, added information for special patient groups
Section 4.3 - added contraindication for hypersensitivity to active ingredients and excipients
Section 4.4 - added statement regarding calcium and statement to limit treatment duration as much as possible
Section 4.5 - added a 2 hour time interval between taking Gaviscon and other specified products
Section 4.6 - added more detailed information on taking Gaviscon for Pregnancy, breastfeeding, and fertility
Section 4.7 - Updated wording
Section 4.8 - updated frequencies
Section 5.1 - added pharmacotherapeutic group
Section 10 - Changed Date of revision of text
Section 4.3 - added contraindication for hypersensitivity to active ingredients and excipients
Section 4.4 - added statement regarding calcium and statement to limit treatment duration as much as possible
Section 4.5 - added a 2 hour time interval between taking Gaviscon and other specified products
Section 4.6 - added more detailed information on taking Gaviscon for Pregnancy, breastfeeding, and fertility
Section 4.7 - Updated wording
Section 4.8 - updated frequencies
Section 5.1 - added pharmacotherapeutic group
Section 10 - Changed Date of revision of text
Updated on 13 December 2012
Reasons for updating
- 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
In section 4.4, added "Contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).
Updated on 13 December 2012
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Free text change information supplied by the pharmaceutical company
In section 4.4, added "Contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).
Updated on 17 April 2012
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
- 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
Updated to amend section 9 to detail date of last renewal to 03/05/2008
Updated to amend section 10 date of revsion of text to September 2008
Updated to amend section 10 date of revsion of text to September 2008
Updated on 17 April 2012
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Updated to amend section 9 to detail date of last renewal to 03/05/2008
Updated to amend section 10 date of revsion of text to September 2008
Updated to amend section 10 date of revsion of text to September 2008
Updated on 18 December 2008
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 9 - Date of renewal of authorisation
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
all changes as a result of license renwal
Updated on 18 December 2008
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 9 - Date of renewal of authorisation
Free text change information supplied by the pharmaceutical company
all changes as a result of license renwal
Updated on 15 May 2007
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to marketing authorisation holder address
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
SECTION 4.8. Allergic manifestations expanded to include anaphylactic and anaphylactoid reactions.
SECTION 7. Change of marketing authorisation holder address to: 7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland.
Updated on 15 May 2007
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to marketing authorisation holder address
Free text change information supplied by the pharmaceutical company
SECTION 4.8. Allergic manifestations expanded to include anaphylactic and anaphylactoid reactions.
SECTION 7. Change of marketing authorisation holder address to: 7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland.
Updated on 01 July 2005
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Supply through pharmacy only
Updated on 01 July 2005
Reasons for updating
- Change to section 6.3 - Shelf life
Updated on 20 May 2005
Reasons for updating
- Improved electronic presentation
Legal category:Supply through pharmacy only
Updated on 20 May 2005
Reasons for updating
- Improved electronic presentation
Updated on 11 August 2004
Reasons for updating
- Improved electronic presentation
Legal category:Supply through pharmacy only
Updated on 11 August 2004
Reasons for updating
- Improved electronic presentation
Updated on 16 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
Reckitt Benckiser Ireland Limited
Address:
7 Riverwalk, Citywest Business Campus, Dublin 24, IrelandTelephone:
+353 1 468 9200Fax:
+353 1 468 9299