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Pharmacosmos UK Limited
Chiltern House, Unit P, Howland Road, Thame, Oxfordshire, OX9 3GQ
Telephone: +44 (0)1844 269007
Fax: +44 (0)1844 269005
Medical Information Direct Line: +44 (0)1844 269 007
Medical Information e-mail: info@pharmacosmos.co.uk
Medical Information Fax: +44 (0)1844 269005

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 05/04/2012
SPC Phosex 1000mg Tablets

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 05/04/2012 and displayed until Current
Reasons for adding or 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
Date of revision of text on the SPC:   01-Oct-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 7 marketing authorisation holder has changed to Pharmacosmos A/S.
In section 8 MA number has changed to PL 18380/0003.
In section 10 last revision date has changed to October 2011.
Updated on 25/10/2010 and displayed until 05/04/2012
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-May-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 3 the tablet description has changed to 'Oval yellow tablet embossed "PHOS-EX" on one side with a score-line on the reverse'.

In section 4.2 the wording 'Where the patient cannot swallow the tablets whole they may be broken and taken with food. Tablets, whether whole or broken, should not be chewed due to their bitter taste'.

In section 10 the Date of Revision of the Text has changed to May 2010.
Updated on 24/06/2009 and displayed until 25/10/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Mar-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 2: term a full list of excipients added.

In section 4.4 the following statement has been added: Patients suffering with progressive renal failure may exhibit signs of, and should be warned of the symptoms of, hypercalcaemia, ectopic or vascular calcification, or adynamic bone disease. Regular monitoring is required since caution is needed in administering Phosex®  under these circumstances.

In section 9: 22 December 2007 added.

In section 10: date changed to March 2009.
Updated on 27/06/2007 and displayed until 24/06/2009
Reasons for adding or updating:
  • Change to MA holder contact details
Date of revision of text on the SPC:   05/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 

Black Triangle removed as no longer applicable.

Section 4.1  Minor change to wording.

Section 4.2  Repositioning of text to highlight Test dose.

                    (Dosage)  Warning concerning not administering Cosmofer

                     concomitantly with oral iron.

Section 4.4  Repositioning of text to highlight allergic reactions in patients with

                     immune or inflammatory conditions.

Section 4.6  Expansion of the use of Cosmofer in pregnancy.

Section 4.8  Repositioning of text to highlight anaphylactoid reactions. Expansion of

                    undesirable effect table to include sections on the following organ

                    classes: Blood and lymphatic system, Immune system, Psychiatric

                    disorders, Vascular system.

Section 5.3  Change in units, update to in vitro/vivo genotoxicity.

Section 6.6  Addition of intravenous dilution solutions to this section.

Section 10.  Date of revision changed to June 6, 2007.
Updated on 25/06/2007 and displayed until 27/06/2007
Reasons for adding or updating:
  • Change to MA holder contact details
Date of revision of text on the SPC:   05/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 7. Change of address for MA holder
Section 10 Date of revision of text May 2007
Updated on 09/03/2004 and displayed until 25/06/2007
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  calcium acetate