Kalcipos-D forte 500mg/800 IU chewable tablets
- Name:
Kalcipos-D forte 500mg/800 IU chewable tablets
- Company:
Mylan IRE Healthcare Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 20/10/20
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Mylan IRE Healthcare Limited
Company Products
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 20 October 2020 SPC
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 PIL
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 PIL
Reasons for updating
- Change to product name
Updated on 8 November 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 7 November 2018 SPC
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 SPC
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 SPC
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 SPC
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 PIL
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 1 December 2015 SPC
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 1 December 2015 PIL
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 PIL
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 10 October 2013 SPC
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 27 November 2012 PIL
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 27 November 2012 SPC
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 13 November 2012 PIL
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 13 November 2012 SPC
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 7 November 2012 PIL
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 7 November 2012 SPC
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 21 September 2012 SPC
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 PIL
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 SPC
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 PIL
Reasons for updating
- New SPC for medicines.ie