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E. R. Squibb & Sons Limited
Uxbridge Business Park , Sanderson Road, Uxbridge, Middlesex, UB8 1DH , UK
Telephone: +44 (0)1895 523 000
Fax: +44 (0)1895 523 010
Medical Information Direct Line: +44 (0)1895 523 740
Medical Information e-mail: Medical.information@bms.com
Medical Information Fax: +44 (0)1895 523 677

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: 17/11/2011
SPC Hydrea 500 mg Hard Capsules

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 17/11/2011 and displayed until Current
Reasons for adding or updating:
  • Addition of Legal Category
Date of revision of text on the SPC:   03-Oct-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Added the Legal Category section to the SPC. Legal Category is POM.
Updated on 16/11/2011 and displayed until 17/11/2011
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   03-Oct-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


 

In section 4.5 the following paragraph has been added as the 2nd paragraph of this section:

 

Studies have shown that there is an analytical interference of hydroxycarbamide with the enzymes (urease, uricase, and lactic dehydrogenase) used in the determination of urea, uric acid and lactic acid, rendering falsely elevated results of these in patients treated with hydroxycarbamide.

Section 10 has been amended from 02 July 2010 to 03 October 2011

 
Updated on 12/07/2010 and displayed until 16/11/2011
Reasons for adding or updating:
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   02-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.4:  Changed storage conditions to
 'Do not store above 25°C.  Keep in the outer container in order to protect from moisture

Section 10: 02 July 2010
Updated on 18/06/2010 and displayed until 12/07/2010
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 3 - Shelf Life
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   02-Jun-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
SPC revised in line with SPC QRD Template.
Section 1.  - Product name change to include strength and full pharmaceutical form.
Section 2. - Includes lactose quantity and reference to refer to Section 6.1 for full list of excipients.
Section 3. - Description of capsule included
Section 5.1 - ATC Code included
Section 6.1 - Excipients defined further and on separate lines for clarity
Section 6.2 - None Known changed to Not applicable.
Section 6.3 - Shelf life expressed in years
Updated on 21/04/2010 and displayed until 18/06/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   31-Mar-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 - Addition of the Lactose warning statement.
Updated on 26/01/2010 and displayed until 21/04/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   15-Jan-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.8 revised as per MEDRA terminology
Updated on 31/10/2006 and displayed until 26/01/2010
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

 
  hydroxycarbamide