Kalcipos-D forte 500 mg/ 800 IU film-coated tablets * Pharmacy Only: Prescription
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 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
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
Updated on 30 November 2012
Reasons for updating
- New SPC for new product