Calcichew-D3 Forte Chewable Tablets
Product Information *
Company:
Takeda Products Ireland LtdStatus:
No Recent UpdateActive Ingredients :
*Additional information is available upon request
Legal Category:
Product subject to medical prescription which may be renewed (B)
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 22 May 2020
File name
ie-pl-clean_1590165504.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
In section 6, the MAH (Takeda Products Ireland Ltd) address has been changed to 6th Floor, South Bank House, Barrow Street, Dublin 4, Ireland
This is the new legally registered office.
The date of revision of the PIL is February 2020.
Updated on 22 May 2020
File name
ie-spc-clean_1590165408.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- 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 7, the MAH (Takeda Products Ireland Ltd) address has been changed to 6th Floor, South Bank House, Barrow Street, Dublin 4, Ireland
This is the new legally registered office.
The date of revision of the SmPC is 4th May 2020.
Updated on 22 August 2019
File name
m1-3-1-SmPC-D3 Forte-IRE-proposed clean_1566486408.pdf
Reasons for updating
- File format updated to PDF
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 11 June 2018
File name
m1-3-1-SmPC-D3 Forte-IRE-proposed clean.docx
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- 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
MA holder has been updated to Takeda Pharmaceutical Ireland Ltd. Date of revision updated to 25 May 2018.
Updated on 11 June 2018
File name
m1-3-1-PIL-D3 Forte-IRE-proposed clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 09 October 2017
File name
PIL_15950_229.pdf
Reasons for updating
- New PIL for new product
Updated on 09 October 2017
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 19 September 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 19 September 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - excipient warnings
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 19 September 2017
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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
|
Change to section |
Details of change |
|
2. QUALITATIVE AND QUANTITATIVE COMPOSITION |
Excipients with known effect For |
|
4.4 Special warnings and precautions for use |
Calcichew-D3 Forte Chewable Tablets contain |
|
6.1 List of excipients |
Xylitol (E967)
Povidone Isomalt (E953) Flavouring (lemon) Fatty acid mono- and diglycerides Sucralose (E955 Magnesium stearate Sucrose Modified maize starch Triglycerides, medium-chain Sodium ascorbate Silica, colloidal anhydrous Tocopherol |
|
10. DATE OF THE REVISION OF THE TEXT |
|
Updated on 26 August 2016
Reasons for updating
- Change to section 10 - Date of revision of the text
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 6.3 Shelf life of the SmPC has been updated to reduce the shelf-life of Calcichew D3 Forte Chewable Tablets from 3 years to 30 months.
Updated on 16 May 2016
Reasons for updating
- Change to section 1 - Name of medicinal product
- 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 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- 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
Updated on 13 May 2016
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change of contraindications
- Change to instructions about missed dose
- Change to instructions about overdose
- Change to storage instructions
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to information about driving or using machinery
- Change to how the medicine works
- Change to date of revision
Updated on 23 September 2015
Reasons for updating
- Change to further information section
Updated on 20 February 2015
Reasons for updating
- 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
Section 4.8- following text has been added:
Other special populations
Patients with renal impairment: potential risk of hyperphosphatemia, nephrolithiasis and nephrocalcinosis. See section 4.4.
Further wording added for reporting of suspected adverse reactions to HPRA
Date of revision amended to 5th of Feburary 2015
Updated on 16 February 2015
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 20 November 2014
Reasons for updating
- Change to further information section
Updated on 07 October 2014
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
- Change to MA holder contact details
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Changes are in the following sections:
SECTION 7. MARKETING AUTHORISATION HOLDER
Takeda UK Limited
Building 3
Glory Park
Glory Park Avenue
Wooburn Green
Bucks
HP10 0DF
SECTION 10. DATE OF REVISION OF THE TEXT
26/09/2014
Updated on 07 October 2014
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 25 February 2014
Reasons for updating
- New PIL for new product
Updated on 17 February 2014
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)