Bonefos Tablets
Last Updated on eMC 23-Jun-2016 View document | Bayer plc Contact details
Versions
- 23-Jun-2016 to Current
- 11-Jan-2016 to 23-Jun-2016
- 08-Aug-2014 to 11-Jan-2016
- 15-Jul-2013 to 08-Aug-2014
- 31-Aug-2011 to 15-Jul-2013
- 13-May-2011 to 31-Aug-2011
- 25-Nov-2010 to 13-May-2011
- 28-Jun-2010 to 25-Nov-2010
- 24-Mar-2010 to 28-Jun-2010
- 26-Jun-2009 to 24-Mar-2010
- 03-Jun-2009 to 26-Jun-2009
- 08-May-2009 to 03-Jun-2009
- 12-Jun-2008 to 08-May-2009
- 17-Jan-2007 to 12-Jun-2008
- 05-Jan-2006 to 17-Jan-2007
- 01-Aug-2001 to 05-Jan-2006
- 10-Oct-2000 to 01-Aug-2001
- 06-Sep-1999 to 10-Oct-2000
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 23-Jun-2016 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 - how to report a side effect
Date of revision of text on the SPC: 16-Jun-2016
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
SmPC
· Under section 4.4 ‘Special warnings and precautions for use’ the following statement has been added:
‘Osteonecrosis of the external auditory canal
Osteonecrosis of the external auditory canal has been reported with bisphosphonates, mainly in association with long-term therapy. Possible risk factors for osteonecrosis of the external auditory canal include steroid use and chemotherapy and/or local risk factors such as infection or trauma. The possibility of osteonecrosis of the external auditory canal should be considered in patients receiving bisphosphonates who present with ear symptoms including chronic ear infections.’
· Under section section 4.8 the following statement has been added to the ADR table under frequency Very rare < 1/10,000
‘Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction).’
Updated on 11-Jan-2016 and displayed until 23-Jun-2016
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 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Fertility, pregnancy and lactation
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
Date of revision of text on the SPC: 30-Sep-2015
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Section 1. Name of Medicinal Product
· Changed from ‘Bonefos® Tablets’ to ‘Bonefos 800 mg tablets’.
Section 2. Qualitative and Quantative Composition
· A reference to the full list of excipients in section 6.1 has been added.
Section 4.2 Posology and method of administration
· This section has been rearranged into a ‘Posology’ and ‘Method of administration’ section and ‘Children’ has been changed to ‘ Paediatric population’
Section 4.4 Special warnings and precautions for use
· ‘Renal insufficiency’ has been changed to ‘renal impairement’.
Section 4.6 Fertility, pregnancy and lactation
· This section has been rearranged and ‘lactation’ has been changed to ‘Breast-feeding’.
Section 4.9 Overdose
· Treatment’ has been changed to ‘Management’
Section 5.1 Pharmacodynamic properrites
· The ‘Pharmacotherapeutic group’ and ‘ATC code’ have been added.
Section 6.3 Shelf life
· The shelf life statement has been simplified to just state ‘3 years’.
Section 6.4 Special precautions for storage
· The statement has been reworded to ‘Do not store above 25°C’
Updated on 08-Aug-2014 and displayed until 11-Jan-2016
Reasons for adding or updating:
- Change to section 4.2 - Posology and method of administration
- Change to section 4.9 - Overdose
- Change to section 10 - Date of revision of the text
Date of revision of text on the SPC: 23-Jul-2014
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Sections 4.2 and 4.9 - update of the recommendations on clodronate dosage for patients with renal insufficiency and to bring the SmPC into line with the agreed Core Safety Profile.
Updated on 15-Jul-2013 and displayed until 08-Aug-2014
Reasons for adding or updating:
- Change to section 4.6 - Fertility, pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC: 26-Jun-2013
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Summary of the changes made:
· Information regarding fertility has been added to section 4.6 of the SmPC
· Eye disorder side effects has been added to section 4.8 of the SmPC as well as section 4 of the leaflet
· The wording ‘Bayer Schering Pharma’ has been removed from the section 7 of the SmPC as well as on the carton labels.
Updated on 31-Aug-2011 and displayed until 15-Jul-2013
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-May-2011 and displayed until 31-Aug-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-Nov-2010 and displayed until 13-May-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-Jun-2010 and displayed until 25-Nov-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-Mar-2010 and displayed until 28-Jun-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-Jun-2009 and displayed until 24-Mar-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-Jun-2009 and displayed until 26-Jun-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-May-2009 and displayed until 03-Jun-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-Jun-2008 and displayed until 08-May-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-Jan-2007 and displayed until 12-Jun-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: 01-Nov-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
Section 4.8 – following text has been added:
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-Jan-2006 and displayed until 17-Jan-2007
Reasons for adding or updating:
- Change to section 7 - Marketing Authorisation Holder
Updated on 01-Aug-2001 and displayed until 05-Jan-2006
Reasons for adding or updating:
- Transferred from eMC version 1
- Change of Marketing Authorisation Holder.
Updated on 10-Oct-2000 and displayed until 01-Aug-2001
Reasons for adding or updating:
- No reasons supplied
Updated on 06-Sep-1999 and displayed until 10-Oct-2000
Reasons for adding or updating:
- No reasons supplied
Bayer plc
Bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA
+44 (0)1635 563 393
+44 (0)1635 563 000
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