Kalcipos-D forte 500 mg/ 800 IU film-coated tablets *

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 15 June 2021

File name

ie-spc-se0805-fct-v035-clean_1623777821.pdf

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

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

Updated on 15 June 2021

File name

ie-pl-se0805-fct-v035-clean_1623777787.pdf

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 20 October 2020

File name

ie-spc-se0805-fct-v031g-clean_1603198290.pdf

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 4.8 - 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
  • Change to section 12 - Instructions for preparation of radiopharmaceuticals

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

Updated on 20 October 2020

File name

ie-spc-se0805-fct-v031g-clean_1603197862.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

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

Updated on 20 October 2020

File name

ie-pl-se0805-fct-v031g-clean_1603197793.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 12 April 2020

File name

ie-pl-se0805-chewable-v029-clean_1586679049.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 17 January 2020

File name

ie-pl-se0805-fct-v028g-clean_1579272914.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 22 August 2019

File name

ie-pl-se0805-fct-v026-clean_1566405409.pdf

Reasons for updating

  • Change to name of medicinal product

Updated on 08 November 2018

File name

ie-pl-se0805-fct-clean-mahtransfer_1541611999.pdf

Reasons for updating

  • New PIL for new product

Updated on 07 November 2018

File name

ie-spc-se0805-fct-mahtransfer-clean_1541612062.pdf

Reasons for updating

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

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

Updated on 16 July 2018

File name

Kalcipos_FCT_SmPC_July_2018.docx

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • 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

In section 4.4: Information regarding milk-alkali syndrome added

In section 4.6: Information regarding pregnancy added

In section 4.8: Full adverse reaction definitions added

In section 5.1: Information regarding pharmacotherapeutic group added

In section 5.2: Information regarding absorption, distribution added

In section 10: Date of revision changed.

Updated on 27 July 2017

Reasons for updating

  • New SPC for new product

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

Updated on 27 July 2017

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 5.2 - Pharmacokinetic properties
  • 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

In section 4.1: Information regarding indication for adults and children over 18 years has been added

In section 5.2: Pharmacokinetic properties information has been added

In section 10: Date of revision changed.

 

Updated on 27 July 2017

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 4.1: Information regarding indication for adults and children over 18 years has been added

In section 5.2: Pharmacokinetic properties information has been added

In section 10: Date of revision changed.

 

Updated on 12 January 2016

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 2: there is a slight text change

In section 4,2: Restructuring to this section has been undertaken

In section 4.3: Slight amendment to information added

In section 4.5: Information regarding calcium salts has been added. Information regarding orlistat has been added.

In section 4.7: Warning in relation to driving and use of machinery has been added

In section 4.8: Information regarding patients with renal impairment has been added

In section 5.2: Minor text added

In In section 10: The date of revision has been changed.

Updated on 12 January 2016

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • 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

In section 2: there is a slight text change

In section 4,2: Restructuring to this section has been undertaken

In section 4.3: Slight amendment to information added

In section 4.5: Information regarding calcium salts has been added. Information regarding orlistat has been added.

In section 4.7: Warning in relation to driving and use of machinery has been added

In section 4.8: Information regarding patients with renal impairment has been added

In section 5.2: Minor text added

In In section 10: The date of revision has been changed.

Updated on 10 October 2013

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • 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

In section 5.1: Additional information has been added to this section outlining the results of a clinical study

In section 10: The date of revision has been changed.

Updated on 10 October 2013

Reasons for updating

  • 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

In section 5.1: Additional information has been added to this section outlining the results of a clinical study

In section 10: The date of revision has been changed.

Updated on 30 November 2012

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 30 November 2012

Reasons for updating

  • New SPC for new product

Free text change information supplied by the pharmaceutical company

None provided