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Calcium Resonium

*
Pharmacy Only: Prescription

  • Company:

    SANOFI

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

  • Active Ingredient(s):

    Calcium Polystyrene Sulfonate

    *Additional information is available within the SPC or upon request to the company

Updated on 18 December 2023

File name

1.3.1 PIL text Calcium Resonium (3).pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 18 December 2023

File name

1.3.1 SPC Calcium resonium.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 19 May 2023

File name

1.3.1 PIL text Calcium Resonium.pdf

Reasons for updating

  • Correction of spelling/typing errors

Updated on 03 March 2023

File name

1.3.1 PIL text Calcium Resonium.pdf

Reasons for updating

  • Change to section 2 - excipient warnings

Updated on 03 March 2023

File name

1.3.1 SPC Calcium resonium (2).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:Product subject to medical prescription which may be renewed (B)

Updated on 15 December 2021

File name

1.3.1 SPC Calcium resonium.pdf

Reasons for updating

  • 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:Product subject to medical prescription which may be renewed (B)

Updated on 15 December 2021

File name

1.3.2 Calcium Resonium Fixaform (1).pdf

Reasons for updating

  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 12 July 2021

File name

PIL CALCIUM RES 300G IE-H.pdf

Reasons for updating

  • XPIL Removed

Updated on 06 July 2020

File name

PIL CALCIUM RES 300G IE-H.pdf

Reasons for updating

  • XPIL Removed

Updated on 05 February 2019

File name

PIL CALCIUM RES 300G IE-H.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 3 - duration of treatment
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 11 January 2019

File name

SPC Calcium Resonium powder for oral or rectal suspensiion .pdf

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

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Oral    

The usual dose is 15g, 3 to 4 times a day.  The resin is given by mouth in a little water, or it may be made into a paste with some sweetened vehicle.

 

Administer Calcium Resonium at least 3 hours before or 3 hours after other oral medications. For

patients with gastroparesis, a 6-hour separation should be considered1 (see Section 4.4 and Section

4.5).

 

    1. Special warnings and special precautions for use
       
      Binding to other orally administered medications: Calcium Resonium may bind to orally administered medications, which could decrease their gastrointestinal absorption and efficacy. Avoid co-administration of Calcium Resonium with other orally administered medications. Administer Calcium Resonium at least 3 hours before or 3 hours after other oral medications. For patients with gastroparesis, a 6-hour separation should be considered (see Section 4.2 and Section 4.5).
       

 

4.5       Interaction with other medicinal products and other forms of interaction

 

Concomitant use not recommended

 

Orally administered medications: Calcium Resonium has the potential to bind to other orally administered medications. Binding of Calcium Resonium to other oral medications could cause decrease in their gastrointestinal absorption and efficacy. Dosing separation of Calcium Resonium from other orally administered medications is recommended (see Section 4.2 and Section 4.4).

 

 

Updated on 01 July 2014

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 01 July 2014

Reasons for updating

  • 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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4: Sorbitol paragraph updated.
Section 4.5: 'other serious gastrointestinal adverse reactions' included.
Section 4.8: Gastrointestinal disorders updated.
Section 4.9: to include '(potassium, calcium)'.

Updated on 07 February 2013

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4 updated as warning relating to Sorbitol incomplete as statement 'be fatal' was omitted during last Company Core Data Sheet update.

Updated on 04 February 2013

File name

PIL_9167_552.pdf

Reasons for updating

  • New PIL for new product

Updated on 04 February 2013

Reasons for updating

  • Change of manufacturer
  • Change to warnings or special precautions for use

Updated on 04 May 2011

Reasons for updating

  • Improved electronic presentation

Updated on 06 August 2010

Reasons for updating

  • 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 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company


Change to Section 4.4 - Special warnings and special precautions for use.  Changes made to bring in line with company core data sheet 
Change to Section 4.5 - Interactions with other medicinal productions and other forms of interaction.  Changes made to bring in line with company core data sheet.
Change to Section 4.8 - Undesirable effects.  Changes made to bring in line with company core data sheet.

Updated on 05 August 2010

Reasons for updating

  • Change to side-effects
  • Change to improve clarity and readability

Updated on 04 December 2009

Reasons for updating

  • Change due to user-testing of patient information

Updated on 15 December 2008

Reasons for updating

  • Correction of spelling/typing errors

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 05 September 2008

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update section 7, 8 and 10.

Updated on 05 September 2008

Reasons for updating

  • Change to marketing authorisation holder

Updated on 25 July 2008

Reasons for updating

  • Improved electronic presentation

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 27 August 2007

Reasons for updating

  • Improved electronic presentation

Updated on 09 August 2007

Reasons for updating

  • Improved electronic presentation

Updated on 18 December 2006

Reasons for updating

  • Improved electronic presentation

Updated on 28 July 2005

Reasons for updating

  • Improved electronic presentation

Updated on 26 April 2005

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 21 October 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 01 July 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 26 June 2003

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)