Calcichew 500mg 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 21 May 2020
File name
m1-3-1-leaflet-500mg-ire-mah-address-may20-proposed-clean_1590066579.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 21 May 2020
File name
m1-3-1-spc-500mg-ire-proposed clean_1590064501.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 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.
In section 10, the date of revision has been updated to 4th May 2020.
Updated on 15 August 2018
File name
Calcichew 500mg Chewable IRE 02.08.2018_1534354296.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The changes were to correct typos in sections 4.8 and 5.1 of the SmPC and to delete wording in section 4.4. No updates were needed to the leaflet-label on the bottle
Updated on 11 June 2018
File name
m1-3-1-spc-500mg-IRE-proposed clean.docx
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)
Free text change information supplied by the pharmaceutical company
Updated to transfer MA holder to Takeda Products Ireland Ltd. Date of revision updated to 25 May 2018.
Updated on 11 June 2018
File name
m1-3-1-leaflet-500mg-IRE-proposed clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 07 July 2016
File name
PIL_15949_550.pdf
Reasons for updating
- New PIL for new product
Updated on 07 July 2016
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to instructions about missed dose
- Change to storage instructions
- Change to side-effects
- Change to drug interactions
- Change to information about drinking alcohol
- Change to information about driving or using machinery
- Change to date of revision
Updated on 23 September 2015
Reasons for updating
- Change to further information section
Updated on 18 June 2015
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 18 June 2015
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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
Key change is to the HPRA website link for reporting AE's:
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.
Updated on 22 May 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
The updated Calcichew 500mg Chewable Tablets contain changes 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 25 February 2014
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)