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Bayer plc
Bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA
Telephone: +44 (0)1635 563 000
Fax: +44 (0)1635 563 393
WWW: http://www.bayer.co.uk

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: 31/08/2011
SPC Bonefos 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 31/08/2011 and displayed until Current
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 10 date of revision of the text
Date of revision of text on the SPC:   01-Aug-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 (Special warnings) - Addition of text concerning  "Atypical fractures of the femur"
Section 4.8 (Undesirable effects) - The table  has been updated to present "Atypical subtrochanteric and diaphyseal femoral fractures" as a potentially rare adverse reaction.
Section 10 (Revision date) this is now August 2011.
Updated on 13/05/2011 and displayed until 31/08/2011
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   09-May-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.1 (Pharmaceutical particulars) - change to the coating of the pill.
Section 10 - revision date is now 9 May 2011
Updated on 25/11/2010 and displayed until 13/05/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   09-Nov-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The key changes to the SmPC are:

  • Section 4.2 - update the information on the standard adult dosage and administration of Bonefos relating to timing of administration in relation to food intake
  • Add more information on use in patients with renal insufficiency (which lead to consequential changes in sections 4.3, 4.4 and 5.2)
Updated on 28/06/2010 and displayed until 25/11/2010
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   18-Jun-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 5.3 ( Preclinical safety data): of the SmPC has been significantly updated to provide additional information where previously it was stated that no further relevant information was available, including sub-sections on systemic tolerance, reproduction toxicity and carcinogenicity.
Section 4.6 ( Pregnancy and lactation): was updated to refer to reproductive toxicity studies in section 5.3.
Section 10 ( Revision date) : This is now 18 June 2010
Updated on 24/03/2010 and displayed until 28/06/2010
Reasons for adding or updating:
  • Change to section 5.2 - Pharmacokinetic Properties
Date of revision of text on the SPC:   03-Jun-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 5.2 - Pharmacokinetic properties - under the heading  Distribution and Elimination:  we have removed the text "Clodronate is effectively removed from plasma by haemodialysis." - this is currently under assessment.

The revision date remains the same is June 2009.
Updated on 26/06/2009 and displayed until 24/03/2010
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   03-Jun-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.3 Contraindications

Removal of the contraindications in children, pregnant and lactating women and modify the wording of the hypersensitivity contraindication.

This leads to a consequential update of Section 4.6 Pregnancy and lactation:

This section has been updated in line with available data and recent guidelines. Bonefos is not recommended during pregnancy and in women of childbearing potential not using effective contraception; breast-feeding should be discontinued during treatment with Bonefos.

Section 4.5 Interactions

Inclusion of additional warning surrounding concomitant use of estramustine phosphate with clodronate; consequent removal of the sentence that states there is no evidence that sodium clodronate interacts with other medication such as steroids, diuretics, analgesics or chemotherapeutic agents.

Section 4.8 Undesirable effects

This section has been reformatted from text only into a table and converted into MedDRA terminology. The side effects are distinguished as 'Common' 'Rare' and 'Frequency unknown'. Additionally, information on severe renal damage has been added, acknowledging that there have been isolated reports of fatal outcomes, especially with concomitant use of NSAIDS, most often diclofenac. A statement to describe reports of severe bone, joint and/or muscle pain is also added.

Section 4.9 Overdose

The text has been updated based on real observations, rather than being based on a theoretical scenario. The section is now split into 2 parts: Symptoms and Treatment.

Section 10 - revision date - this is now 3 June 2009
Updated on 03/06/2009 and displayed until 26/06/2009
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 4.1 - Therapeutic indications
  • 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:   29-May-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1- Product is now officially called "Bonefos Tablets" as opposed to Bonefos.
Section 4.1 - has been updated to remove the specific reference to Bonefos concentrate and replaces it with a general reference to intravenous bisphosphonate treatment as we have now discontinued and are in the process of cancelling the Bonefos Concentrate licence.
Section 6.5 - editorial update to aid clarity and phrase "Not all pack sizes may be marketed" has been added.
Section 10 - Revision date is now 29 May 2009
Updated on 08/05/2009 and displayed until 03/06/2009
Reasons for adding or updating:
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   13-Mar-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 5.2 (Pharmcokinetic properties) - information has been updated in line iwht company sponsered study reports.

Section 10 - revision date is now 29 March 2009.
Updated on 12/06/2008 and displayed until 08/05/2009
Reasons for adding or updating:
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 10 date of revision of the text
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   01-May-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


All updates are due to change of ownership, from Schering Healthcare Ltd to Bayer Plc effective from 1 May 2008

Section 7: MAH now Bayer plc
Section 8: Licence number is now PL 00010/ 0522
Section 9: Date of first authorisation is now 1 May 2008
Section 10: Revision date is now 1 May 2008 
Updated on 17/01/2007 and displayed until 12/06/2008
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 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:   11/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.4 – the following text has been added:

 

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 oral bisphosphonates.

 

A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g. cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene).

 

While on treatment, these patients should avoid 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 the 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.

 

Section 4.8 – following text has been added:

 

Isolated cases of osteonecrosis of the jaw have been reported, primarily in patients who were previously treated with amino-bisphosphonates like zoledronate and pamidronate (see also section “Special warnings and special precautions for use”).
 

Section 6.5       Tablets – removal of  10 tablet pack size

           

 

Section 10 – Revision date amended from 10 July 2006 to 16 November 2006.

 
Updated on 05/01/2006 and displayed until 17/01/2007
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 01/08/2001 and displayed until 05/01/2006
Reasons for adding or updating:
  • Transferred from eMC version 1
  • Change of Marketing Authorisation Holder.
Updated on 10/10/2000 and displayed until 01/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 10/10/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  disodium clodronate tetrahydrate