Calcichew 500mg Chewable Tablets

Product Information *

  • Company:

    Takeda Products Ireland Ltd
  • Status:

    No Recent Update
  • Active 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)

Free text change information supplied by the pharmaceutical company

None provided