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Pfizer Consumer Healthcare
9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 (0)1 467 6500
Fax: +353 (0)1 467 6501
Medical Information Direct Line: +353 (0)1 467 6627
Summary of Product Characteristics last updated on medicines.ie: 14/05/2015
SPC Caltrate 600mg/400IU Film-coated Tablets

When a pharmaceutical company changes an SPC or PIL, 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 14/05/2015 and displayed until Current
Reasons for adding or updating:
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
Date of revision of text on the SPC:   30-Apr-2015
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company


4.8        Undesirable effects

 



 

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 16/04/2015 and displayed until 14/05/2015
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   09-Apr-2015
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
Added Silicon dioxide & 'hydrolysed' after bovine gelatin 
Updated on 14/07/2014 and displayed until 16/04/2015
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Jul-2014
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
In section 6.5, the additional pack size of '20' was added

In section 10, the date of revision has changed to 'July 2014'
Updated on 13/02/2013 and displayed until 14/07/2014
Reasons for adding or updating:
  • Change to marketing authorisation holder
Date of revision of text on the SPC:   08-Feb-2013
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company


7.       MARKETING AUTHORISATION HOLDER

 

Pfizer Healthcare Ireland,

9 Riverwalk,

National Digital Park,

Citywest Business Campus,

Dublin 24,

Ireland.

 

8.         MARKETING AUTHORISATION NUMBER(S)

 

P.A.822/173/001

Updated on 05/10/2012 and displayed until 13/02/2013
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   28-Sep-2012
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
Section 4.8 Undesirable Effects. 

Nephrolithiasis added as a effect, frequency unknown.  
Updated on 14/03/2011 and displayed until 05/10/2012
Reasons for adding or updating:
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   28-Feb-2011
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
Burnett's syndrome added as possible side effect of overdose.
Updated on 29/06/2010 and displayed until 14/03/2011
Reasons for adding or updating:
  • Change to marketing authorisation holder
Date of revision of text on the SPC:   17-Jun-2010
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company


7.       MARKETING AUTHORISATION HOLDER

 

Pfizer Consumer Healthcare Ltd,

Ramsgate Road,

Sandwich,

Kent,

CT13 9NJ, UK.

 
Updated on 19/01/2010 and displayed until 29/06/2010
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
None provided

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Active Ingredients

 
  Calcium Carbonate
  Vitamin D3