Gaviscon Peppermint Chewable Tablets
*Company:
Reckitt Benckiser Ireland LimitedStatus:
No Recent UpdateLegal Category:
Supply through general saleActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 15 January 2020
File name
Gaviscon Peppermint Chewable Tablets.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 26 October 2017
Reasons for updating
- New SPC for new product
Legal category:Supply through general sale
Updated on 26 October 2017
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Update to section 4 as part of Renewal assessment.
Updated on 13 October 2017
File name
PIL_15021_66.pdf
Reasons for updating
- New PIL for new product
Updated on 13 October 2017
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
Updated on 04 August 2015
Reasons for updating
- Change to warnings or special precautions for use
Updated on 04 September 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 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Section 4.2 - Change to format. Additional information added to special patient groups. Added advice that the clinical situation should be reviewed if symptoms do not improve after 7 days.
Section 4.3 - Contraindication changed to hypersensitivity to sodium alginate, sodium bicarbonate, and calcium carbonate.
Section 4.4 - Removed statement on reduced efficacy in patients with low levels of gastric acid. Removed statement that treatment in children under 12 not recommended.
Section 4.5 - Update to interactions.
Section 4.6 - Formatting update. Specific information added to each category Pregnancy, breastfeeding, and fertility.
Section 4.7 - Minor update to wording.
Section 4.8 - Update to format. Addition of adverse reaction reporting.
Section 5.3 - Change to wording.
Section 10 - Update to Date of revision of the text
Section 4.3 - Contraindication changed to hypersensitivity to sodium alginate, sodium bicarbonate, and calcium carbonate.
Section 4.4 - Removed statement on reduced efficacy in patients with low levels of gastric acid. Removed statement that treatment in children under 12 not recommended.
Section 4.5 - Update to interactions.
Section 4.6 - Formatting update. Specific information added to each category Pregnancy, breastfeeding, and fertility.
Section 4.7 - Minor update to wording.
Section 4.8 - Update to format. Addition of adverse reaction reporting.
Section 5.3 - Change to wording.
Section 10 - Update to Date of revision of the text
Updated on 25 August 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 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.3 - Preclinical safety data
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Section 4.2 - Editorial changes, and what to do if symptoms do last after 7 days. Precaution if highly restricted salt diet is necessary for Renal Insufficiency.
Section 4.3 - minor editorial changes
Section 4.4 - Removal of statement describing the possiblity of reduced efficacy and deletion of statment to not to use on children under 12.
Section 4.5 - Added a time interval between Gaviscon and estramustine of 2 hours and bisphosphonates.
Section 4.6 - Format changed. Update information on use during pregancy.
Section 4.7 - Added that Gaviscon has no influence on ability to drive and use machines.
Section 4.8 - added frequency chart on adverse reactions and reporting requirements
Section 5.3 - change to wording.
Section 4.3 - minor editorial changes
Section 4.4 - Removal of statement describing the possiblity of reduced efficacy and deletion of statment to not to use on children under 12.
Section 4.5 - Added a time interval between Gaviscon and estramustine of 2 hours and bisphosphonates.
Section 4.6 - Format changed. Update information on use during pregancy.
Section 4.7 - Added that Gaviscon has no influence on ability to drive and use machines.
Section 4.8 - added frequency chart on adverse reactions and reporting requirements
Section 5.3 - change to wording.
Updated on 30 August 2012
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Included the following in section 6.5 of SmPC
Single packs 8, 12, 16, 18, 20, 22 or 24 tablets will be packed into cartons.
Updated on 21 June 2011
Reasons for updating
- New individual PIL (was previously included in a combined PIL)
Updated on 14 June 2011
Reasons for updating
- Change due to harmonisation of SPC
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Harmonisation of text
Inclusion of the following in section 4.4 "
Take special care if you are over 40 years and have never suffered with heartburn and acid indigestion before.
Removal of the following text in section 4.6
"Nevertheless, taking into account the presence of calcium carbonate (see Section 5.3) it is recommended to limit the treatment duration as much as possible.
Section 4.8 - addtion of tabulated undesirable effects, and the deletion of the following;
Very rarely (≤1/10,000) patients may develop allergic manifestations such as urticaria or bronchospasm, anaphylactic and anaphylactoid reactions.
Updated on 08 January 2010
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
All sections updated as part of license renewal
Updated on 15 May 2007
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Section 7. Change of address of marketing authorisation holder to: 7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Updated on 04 August 2006
Reasons for updating
- Change to section 6.1 - List of excipients
- Change to section 4.8 - Undesirable effects
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Section 4.8 amended to add reference to anaphylactic and anaphylactoid reactions.
Section 6.1 amended to add the excipients copovidone and acesulfame potassium.
Section 6.4 amended to change the storage condition "Do not store above 30°.
Section 6.5 amended to add more pack sizes.
Updated on 16 May 2005
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Updated on 10 August 2004
Reasons for updating
- Improved electronic presentation
Legal category:Supply through general sale
Updated on 16 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through general sale