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

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Pharmacy Only: Prescription

Updated on 06 December 2023

File name

ie-pl-se0805-fct-MAHt-clean 06 dec 2023.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 06 December 2023

File name

ie-pl-se0805-chew-maht-clean_Kalcipos.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 06 December 2023

File name

ie-spc-se0805-fct-maht-clean_Kalcipos.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 15 June 2021

File name

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

Reasons for updating

  • Change to name of medicinal product

Updated on 08 November 2018

File name

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

Reasons for updating

  • New PIL for new product

Updated on 07 November 2018

File name

ie-spc-se0805-fct-mahtransfer-clean.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

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 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 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