Gaviscon Liquid Aniseed Flavour

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General Sale: Non-prescription

Updated on 14 September 2021

File name

Gaviscon Liquid Aniseed 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 Liquid Aniseed Flavour 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 4.5 - 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 - how to report a side effect

Legal category:Supply through general sale

Updated on 15 January 2020

File name

Gaviscon Liquid Aniseed Flavour.pdf

Reasons for updating

  • New PIL for new product

Updated on 14 June 2016

Reasons for updating

  • New SPC for new product

Legal category:Supply through general sale

Updated on 14 June 2016

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

100ml bottle size has been removed from Section 4.1 and section 4.2 of SmPC

Updated on 14 June 2016

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration

Free text change information supplied by the pharmaceutical company

100ml bottle size has been removed from Section 4.1 and section 4.2 of SmPC

Updated on 19 April 2016

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

Section 6.5 - 100ml bottle size has been deleted

Updated on 19 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 6.5 - 100ml bottle size has been deleted

Updated on 08 September 2014

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 4.5 - 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 10 - Date of revision of the text

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

In section 4.2 - The format has changed. Additional information has been added regarding special patient groups. Added that the clinical situation should be reviewed after 7 days.

Section 4.4 - Added that if symptoms persist after 7 days to consult a doctor. Added additional warnings regarding excipients.

Section 4.5 - Added a time interval between taking Gaviscon and other products.

Section 4.6 - Added specific information to each category Pregnancy, Breast-feeding, and Fertility

Section 4.7 - Changed wording.

Section 4.8 - The format has changed. Added information on how to report suspected adverse events.

Section 10 - Updated the date of revision of the text.

Updated on 08 September 2014

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 4.5 - 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 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 4.2 - The format has changed. Additional information has been added regarding special patient groups. Added that the clinical situation should be reviewed after 7 days.

Section 4.4 - Added that if symptoms persist after 7 days to consult a doctor. Added additional warnings regarding excipients.

Section 4.5 - Added a time interval between taking Gaviscon and other products.

Section 4.6 - Added specific information to each category Pregnancy, Breast-feeding, and Fertility

Section 4.7 - Changed wording.

Section 4.8 - The format has changed. Added information on how to report suspected adverse events.

Section 10 - Updated the date of revision of the text.

Updated on 13 December 2012

Reasons for updating

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

Legal category:Supply through general sale

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 15 May 2007

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable effects

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

SECTION 2.  Qualitative and Quantitative Composition expanded to include the concentration of sodium and parahydroxybenzoate per 10ml dose
 
SECTION 4.3.  Contraindications now includes a statement on hypersensitivity to any of the ingredients.
 
SECTION 4.8.  Allergic manifestations expanded to include anaphylactic and anaphylactoid reactions
 
SECTION 7.  Change of address of marketing authorisation holder to: 7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland.

Updated on 15 May 2007

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

SECTION 2.  Qualitative and Quantitative Composition expanded to include the concentration of sodium and parahydroxybenzoate per 10ml dose
 
SECTION 4.3.  Contraindications now includes a statement on hypersensitivity to any of the ingredients.
 
SECTION 4.8.  Allergic manifestations expanded to include anaphylactic and anaphylactoid reactions
 
SECTION 7.  Change of address of marketing authorisation holder to: 7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland.

Updated on 09 August 2006

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.3 - Shelf life
  • 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

Changes to pack sizes in sections 4.1, 4.2, 4.4 and 6.5.  Pack sizes of 200 and 300ml have been removed from the sections denoting packs for retail sale through pharmacies only and a 300 ml pack has been added to the sections denoting packs for general sale.

Reduction in shelf-life from three years to two years in section 6.3

Updated on 09 August 2006

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container

Free text change information supplied by the pharmaceutical company

Changes to pack sizes in sections 4.1, 4.2, 4.4 and 6.5.  Pack sizes of 200 and 300ml have been removed from the sections denoting packs for retail sale through pharmacies only and a 300 ml pack has been added to the sections denoting packs for general sale.

Reduction in shelf-life from three years to two years in section 6.3

Updated on 19 May 2005

Reasons for updating

  • Improved electronic presentation

Legal category:Supply through general sale

Updated on 19 May 2005

Reasons for updating

  • Improved electronic presentation

Updated on 10 August 2004

Reasons for updating

  • Improved electronic presentation

Legal category:Supply through general sale

Updated on 10 August 2004

Reasons for updating

  • Improved electronic presentation

Updated on 20 August 2003

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation

Legal category:Supply through general sale

Updated on 20 August 2003

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation

Updated on 16 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through general sale

Updated on 16 June 2003

Reasons for updating

  • New SPC for medicines.ie