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Gaviscon Extra Chewable Tablets

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 06/07/20

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Summary of Product Characteristics last updated on medicines.ie: 6/7/2020

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Reckitt Benckiser Ireland Limited

Reckitt Benckiser Ireland Limited

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Medicine Name Disprin Original 300mg Dispersible Tablets Active Ingredients Acetylsalicylic acid (Aspirin)
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Medicine Name Fybogel Mebeverine Active Ingredients Ispaghula Husk, Mebeverine Hydochloride
Medicine Name Fybogel Orange 3.5g Granules Active Ingredients Ispaghula Husk
Medicine Name Gaviscon Advance Chewable Tablets Active Ingredients Potassium Bicarbonate, Sodium Alginate
Medicine Name Gaviscon Advance Oral Suspension Active Ingredients Potassium hydrogen carbonate, Sodium Alginate
Medicine Name Gaviscon Extra Chewable Tablets Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate
Medicine Name Gaviscon Extra Liquid Sachets Peppermint Flavour Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate
Medicine Name Gaviscon Extra Oral Suspension Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate
Medicine Name Gaviscon Infant Active Ingredients Magnesium Alginate, Sodium Alginate
Medicine Name Gaviscon Liquid - Peppermint Flavour Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate
Medicine Name Gaviscon Liquid Aniseed Flavour Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate
Medicine Name Gaviscon Peppermint Chewable Tablets Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Hydrogen Carbonate
Medicine Name Gaviscon Suspension Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate
Medicine Name Hc45 Hydrocortisone Acetate 1% w/w Cream Active Ingredients Hydrocortisone Acetate
Medicine Name Lemsip Chesty Cough 50 mg/5 ml Oral Solution Active Ingredients Guaifenesin
Medicine Name Lemsip Cold & Flu Headcold 500mg Powder for Oral Solution Active Ingredients Paracetamol
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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 6 July 2020 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Supply through general sale

Updated on 6 July 2020 PIL

Reasons for updating

  • Change to section 2 - excipient warnings

Updated on 15 January 2020 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 3 January 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 3 January 2018 PIL

Reasons for updating

  • Change to section 1 - what the product is used for

Updated on 2 January 2018 SPC

Reasons for updating

  • New SPC for new product

Legal category: Supply through general sale

Updated on 2 January 2018 SPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

Addition to Section 5:
Formation of a protective barrier (raft)
Effective impediment of gastro-oesophageal reflux may last for up to 4 hours. 

Updated on 14 June 2016 SPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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 4.8 - Undesirable effects
  • 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 4.3 - update to include a reference to section 6.1
Section 4.5 - Addition of thyroid hormones and estramustine as a consideration for interaction with other medicines
Section 4.6 - New data with regards to use during pregnancy
Section 4.8 - Update to format of undesirable effects
Section 10 - update to date of revision of the text

Updated on 20 August 2014 PIL

Reasons for updating

  • Introduction of new pack/pack size

Updated on 18 November 2011 SPC

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 general sale

Free text change information supplied by the pharmaceutical company

Updated section 9 to include date of last renewal. Resulting in update to section 10

9.      DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

         Date of first authorisation:  01st October 2010

         Date of last renewal:  26th January 2011

 

 

10.    DATE OF REVISION OF THE TEXT

         November 2011

 

Updated on 18 January 2011 SPC

Reasons for updating

  • New SPC for new product

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

None provided

Updated on 14 January 2011 PIL

Reasons for updating

  • New PIL for new product