Kalcipos-D forte 500mg/800 IU chewable tablets *
Pharmacy Only: Prescription

Updated on 15 June 2021

File name

ie-spc-se0805-chew-v034-clean_1623777890.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-chew-v034-clean_1623777864.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-chew-v031g-clean_1603198163.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 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

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

Updated on 20 October 2020

File name

ie-pl-se0805-chew-v031g-clean_1603197972.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 13 August 2019

File name

ie-pl-se0805-chewable-clean-mahtransfer_1541611750.pdf

Reasons for updating

  • Change to product name

Updated on 08 November 2018

File name

ie-pl-se0805-chewable-clean-mahtransfer_1541611750.pdf

Reasons for updating

  • New PIL for new product

Updated on 07 November 2018

File name

ie-spc-se0805-chewable-mahtransfer-clean_1541611802.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_Chewable_Tablets_SmPC_July_2018.docx

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • 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 2: Indication – adults over 18 years

In section 4.3: Severe renal impairment added, Hypercalciuria and hypercalcaemia and diseases and/or conditions resulting in which lead to hypercalcaemia or hypercalciuria added

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 11 January 2016

Reasons for updating

  • New SPC for new product

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

Updated on 11 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 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: Reference to use in children has been removed from this section

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

Updated on 11 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 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: Reference to use in children has been removed from this section

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

Updated on 01 December 2015

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to section 9 - Date of renewal of authorisation
  • 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 3: A slight amendment has been made to the description of the pharmaceutical form

In section 4.4: Very minor typo correct

In section 4.8: adverse reaction reporting statement has been added

In section 5.2: slight correction made to two sub-headings

In section 6.4: Reference to in-use has been added

In section 9: date of last renewal has been added

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

Updated on 01 December 2015

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 3: A slight amendment has been made to the description of the pharmaceutical form

In section 4.4: Very minor typo correct

In section 4.8: adverse reaction reporting statement has been added

In section 5.2: slight correction made to two sub-headings

In section 6.4: Reference to in-use has been added

In section 9: date of last renewal has been added

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 27 November 2012

Reasons for updating

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

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; A correction has been made regarding the content of sucrose

Updated on 27 November 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; A correction has been made regarding the content of sucrose

Updated on 13 November 2012

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients

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: a correction has been made to the sucrose content. it was incorrectly stated to be 3.8mg and this has now been corrected to 1.8mg
In section 6.1: the list of excipients has been amended

Updated on 13 November 2012

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients

Free text change information supplied by the pharmaceutical company

In section 4.4: a correction has been made to the sucrose content. it was incorrectly stated to be 3.8mg and this has now been corrected to 1.8mg
In section 6.1: the list of excipients has been amended

Updated on 07 November 2012

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • 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: text regarding the excipients has been changed

In section 3: additional information regarding the descriptions of the tablet has changed

In section 4.3: text has changed regarding the contraindications

In section 4.5: Additional warning regarding the administration of strontium and calcium has been added.

In section 4.6: additional information regarding fertility has been added

In section 4.8: small correction made to the frequencies

In section 6.3: additional information regarding the in-shelf life use has been added

In section 6.5; the word chewable has been added

In section 10: the revision date has changed

Updated on 07 November 2012

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 2: text regarding the excipients has been changed

In section 3: additional information regarding the descriptions of the tablet has changed

In section 4.3: text has changed regarding the contraindications

In section 4.5: Additional warning regarding the administration of strontium and calcium has been added.

In section 4.6: additional information regarding fertility has been added

In section 4.8: small correction made to the frequencies

In section 6.3: additional information regarding the in-shelf life use has been added

In section 6.5; the word chewable has been added

In section 10: the revision date has changed

Updated on 21 September 2012

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • 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: information regarding the excipients has been removed

In section 4.3: Information regarding hydrogenated soya oil has been removed

In section 4.4: a correction has been made to the quantitative composition of sucrose

In section 6.1: the excipient list has changed

In section 10: the revision date has changed

Updated on 21 September 2012

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 2: information regarding the excipients has been removed

In section 4.3: Information regarding hydrogenated soya oil has been removed

In section 4.4: a correction has been made to the quantitative composition of sucrose

In section 6.1: the excipient list has changed

In section 10: the revision date has changed

Updated on 29 February 2012

Reasons for updating

  • New SPC for medicines.ie

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 29 February 2012

Reasons for updating

  • New SPC for medicines.ie

Free text change information supplied by the pharmaceutical company

None provided