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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: 15/11/2011
SPC Actonel 5mg Film Coated 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 15/11/2011 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:   23-Aug-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Updates to Section 4.4, 4.2 and 4.8
Updated on 07/10/2010 and displayed until 15/11/2011
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Correction of spelling/typing errors
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   10-May-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Bold text has been inluded in the SPC

Section 4.2 

Children: Safety and efficacy of Actonel Combi has not been established in children and adolescents.

Paediatric population: Risedronate sodium is not recommended for use in children below age 18 due to insufficient data on safety and efficacy (also see section 5.1).


Section 4.8

Skin and subcutaneous tissue disorders:
hypersensitivity and skin reactions, including angioedema, generalised rash, urticaria and bullous skin reactions, some severe including isolated reports of Stevens-Johnson syndrome, and toxic epidermal necrolysis and and leukocytoclastic vasculitis.

hair loss.

Section 5.1

Paediatric population: The safety and efficacy of risedronate sodium is being investigated in an on-going study of paediatric patients aged 4 to less than 16 years with osteogenesis imperfecta. After completion of its one-year randomized, double-blind, placebo controlled phase, a statistically significant increase in lumbar spine BMD in the risedronate group versus placebo group was demonstrated; however an increased number of at least 1 new morphometric (identified by x-ray) vertebral fracture was found in the risedronate group compared to placebo. Overall, results do not support the use of risedronate sodium in paediatric patients with osteogenesis imperfecta.

 
Updated on 20/05/2010 and displayed until 07/10/2010
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 10947/0004

10                    Date of Revision of the Text

2010-05-01
Updated on 22/03/2010 and displayed until 20/05/2010
Reasons for adding or updating:
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   30-Oct-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


 

Section 5.1

 

The following spelling change has occurred (red)

 

“In osteoepenic postmenopausal women, risedronate sodium has shown superiority to placebo in increasing lumbar spine BMD at 12 and 24 months”

 

 

“In osteopenic postmenopausal women, risedronate sodium has shown superiority to placebo in increasing lumbar spine BMD at 12 and 24 months”

             

9

9

                   Date of First Authorisation/Renewal of the Authorisation

1999-10-07/2009-08-13

10                    Date of Revision of the Text

2009-10-30
Updated on 16/01/2009 and displayed until 22/03/2010
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:   19-Sep-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 4.8 (undesirable effects) hair loss has been added. The following text has also been added:

"Hepatobiliary disorders:

serious hepatic disorders. In most of the reported cases the patients were also treated with other products known to cause hepatic disorders."

Section 10 Date of Revision of Text has been updated to the following:

2008-09-19
Updated on 18/05/2007 and displayed until 16/01/2009
Reasons for adding or 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
Date of revision of text on the SPC:   03/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.4  Special warnings and special precautions for use
Information on osteonecrosis of the jaw has been added
 
4.8  Undesirable effects
Information on osteonecrosis of the jaw, iritis and uveitis has been added
 
5.1 Pharmacodynamic properties
Efficacy in preventing bone loss paragraph added
 
 
Updated on 16/02/2005 and displayed until 18/05/2007
Reasons for adding or updating:
  • Change to section 9 - Date of Renewal of Authorisation
Updated on 07/02/2005 and displayed until 16/02/2005
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 10/12/2004 and displayed until 07/02/2005
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Updated on 10/12/2004 and displayed until 10/12/2004
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Updated on 10/12/2004 and displayed until 10/12/2004
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Updated on 10/12/2004 and displayed until 10/12/2004
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Updated on 05/08/2004 and displayed until 10/12/2004
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
Updated on 19/07/2004 and displayed until 05/08/2004
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 16/07/2004 and displayed until 19/07/2004
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text
Updated on 20/12/2002 and displayed until 16/07/2004
Reasons for adding or updating:
  • Removal of Black Triangle
Updated on 01/10/2002 and displayed until 20/12/2002
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Improved Electronic Presentation
Updated on 30/09/2002 and displayed until 01/10/2002
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 31/07/2001 and displayed until 30/09/2002
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic Indications
  • 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
  • Change to section 10 (date of (partial) revision of the text
Updated on 21/03/2001 and displayed until 31/07/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 23/08/2000 and displayed until 21/03/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  risedronate sodium