Kalcipos-D forte 500mg/800 IU chewable tablets
*Company:
Mylan IRE Healthcare LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
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-chew-maht-clean.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 30 January 2023
File name
ie-pl-se0805-chew-v041-clean.pdf
Reasons for updating
- Change to name of medicinal product
Updated on 15 June 2021
File name
ie-spc-se0805-chew-v034-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-chew-v034-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-chew-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 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.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.pdf
Reasons for updating
- Change to product name
Updated on 08 November 2018
File name
ie-pl-se0805-chewable-clean-mahtransfer.pdf
Reasons for updating
- New PIL for new product
Updated on 07 November 2018
File name
ie-spc-se0805-chewable-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_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
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
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 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 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
Updated on 29 February 2012
Reasons for updating
- New SPC for medicines.ie