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Warner Chilcott UK Limited
1 The Heights, Brooklands, Weybridge, KT12 0NY
Telephone: +44 (0)1932 82 9600
Fax: +44 (0)1932 82 1644
WWW: http://www.wcrx.com
Medical Information Direct Line: +44 (0)800 0328 701
Medical Information e-mail: medcomukir@wcrx.com
Medical Information Fax: +44 (0)1932 824 775

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: 31/10/2011
SPC Didronel PMO

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 31/10/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   15-Sep-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Updates to Section 4.2, 4.4 and 4.8
Updated on 27/07/2010 and displayed until 31/10/2011
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-May-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


 

7. MARKETING AUTHORISATION HOLDER

Warner Chilcott UK Limited

Old Belfast Road,

Millbrook Road,

Larne,

County Antrim,

BT40 2SH

 

8. MARKETING AUTHORISATION NUMBER(S)

PL 10947/0019

 

 

 

10 DATE OF REVISION OF THE TEXT

01/05/2010
Updated on 20/05/2010 and displayed until 27/07/2010
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   24-Feb-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


10.     DATE OF (PARTIAL) REVISION OF THE TEXT

 

          June 2006



Has changed to:

10. DATE OF REVISION OF THE TEXT

24/02/2009
Updated on 25/10/2006 and displayed until 20/05/2010
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 25/10/2006 and displayed until 25/10/2006
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 25/10/2006 and displayed until 25/10/2006
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   06/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Addition of the following to Section 4.4:

Osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection (including osteomyelitis) has been reported in patients with cancer receiving treatment regimens including primarily intravenously administered bisphosphonates. Many of these patients were also receiving chemotherapy and corticosteroids. Osteonecrosis of the jaw has also been reported in patients with osteoporosis receiving bisphosphonates. 
 
A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patient with concominant risk factors (e.g. cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene).
 
While on treatment, these patients should avod invasive dental procedures if possible. For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces risk of osteonecrosis of the jaw.
 
Clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.    
 
Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Updated on 07/07/2003 and displayed until 25/10/2006
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 25/07/2001 and displayed until 07/07/2003
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
Updated on 29/06/2000 and displayed until 25/07/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 29/06/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  calcium carbonate
  etidronate disodium