FOSAVANCE
*Company:
Organon Pharma (Ireland) LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 14 February 2024
File name
QRD-IE-Fosamax-WS 2467-LFT-CRT.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
Updated on 14 February 2024
File name
QRD-IE-Fosamax-WS 2467-LFT-CRT.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
Updated on 14 February 2024
File name
FOSAVANCE-H-C-0619-WS-2467-SmPC-en-CRT -IE-Jan 24.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 31 January 2023
File name
FOSAVANCE-H-C-0619-T-0050-SmPC-en-CRT April 2021.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 24 November 2021
File name
FOSAVANCE-H-C-0619-N-052-LFT-en-CRT.pdf
Reasons for updating
- Change to other sources of information section
Updated on 16 November 2021
File name
FOSAVANCE-H-C-0619-N-052-PIL-en-CRT.pdf
Reasons for updating
- Change to other sources of information section
Updated on 10 May 2021
File name
QRD-IE-MT-FOSAVANCE-4 TAB-LFT-WRM_.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 10 May 2021
File name
FOSAVANCE-H-C-0619-T-0050-SmPC-en-CRT.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 24 September 2020
File name
QRD PIL IE-MT WS1857 (002).pdf.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Updated on 24 September 2020
File name
SPC WS-1857 (002).pdf.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
SPC updated to include a statement on sodium content
Updated on 03 August 2018
File name
Fosavance PIL Transfer July 2018.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 03 August 2018
File name
Fosavance SPC Transfer July 18.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
MAH holder transferred
Updated on 10 March 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 10 March 2017
Reasons for updating
- Change from individual to joint SPC
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 09 March 2017
File name
PIL_10423_956.pdf
Reasons for updating
- New PIL for new product
Updated on 09 March 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Individual PILs superseded by joint PIL
Updated on 13 May 2016
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Change to Section 4.4 - Special warnings and precautions for use, Change to Section 9 - Date of renewal of authorisation, Change to Section 4.8 - Undesirable effects
Change to Section 10 - Date of revision of the text
SPC Change Details: osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction)
Updated on 12 May 2016
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 06 November 2015
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Changes to sections: 4.4 , 10
Reason for submission: update to section 4.4 Warnings and precautions for use
Updated on 06 November 2015
Reasons for updating
- Change to warnings or special precautions for use
Updated on 14 August 2015
Reasons for updating
- Change to improve clarity and readability
Updated on 03 June 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to drug interactions
- Change to improve clarity and readability
- Addition of information on reporting a side effect.
Updated on 02 June 2015
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 14 October 2013
Reasons for updating
- Change to further information section
Updated on 24 August 2012
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 15 May 2012
Reasons for updating
- Change to section 4.7 - Effects on ability to drive and use machines
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 17 January 2012
Reasons for updating
- Change to further information section
Updated on 07 October 2011
Reasons for updating
- Change to side-effects
Updated on 25 July 2011
Reasons for 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
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 30 June 2011
Reasons for updating
- Change to side-effects
Updated on 08 June 2011
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
SPC sections changed: 6.5 Nature and contents of container - to remove wallet from pack.
Updated on 11 May 2011
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 17 February 2011
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 10 January 2011
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.4 & 4.8 - WS0038 variation relating to Osteonecrosis of the jaw
Section 4.4. Special warnings and precautions for use
Osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection (including osteomyelitis), has been reported in patients with cancer who are 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.
The following risk factors should be considered when evaluating an individual’s risk of developing osteonecrosis of the jaw:
potency of the bisphosphonate (highest for zoledronic acid), route of administration (see above) and cumulative dose
cancer, chemotherapy, radiotherapy, corticosteroids, smoking
a history of dental disease, poor oral hygiene, periodontal disease. invasive dental procedures and poorly fitting dentures.
A dental examination with appropriate preventive dentistry should be considered prior to treatment with oral bisphosphonates in patients with poor dental status.
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.
During bisphosphonate treatment, all patients should be encouraged to maintain good oral hygiene, receive routine dental check-ups, and report any oral symptoms such as dental mobility, pain, or swelling
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, periodontal disease, smoking).
Section 4.8. Undesirable effects
During post-marketing experience the following reactions have been reported (frequency not known):
|
Musculoskeletal, connective tissue and bone disorders: |
Osteonecrosis of the jaw |
Updated on 05 October 2010
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change to side-effects
- Change to drug interactions
- Change to information about driving or using machinery
- Change to how the medicine works
- Change to date of revision
Updated on 16 September 2010
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updates to Sections: 4.1, 4.2, 4.4 ,4.5, 4.6, 4.8, 5.1, 6.1, & 10
Updated on 09 June 2010
Reasons for updating
- Change of manufacturer
Updated on 18 January 2010
Reasons for updating
- Change to warnings or special precautions for use
Updated on 26 November 2009
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Addition of following text to section 4.4
4.4 Special warnings and precautions for use
In patients with known Barrett's oesophagus, prescribers should consider the benefits and potential risks of alendronate on an individual patient basis.
Updated on 27 August 2009
Reasons for updating
- Change to dosage and administration
- Change to side-effects
- Change to information about driving or using machinery
Updated on 10 August 2009
Reasons for 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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The main changes relate to the following:
Section 4.2
Patients should only swallow FOSAVANCE whole. Patients should not crush or chew the tablet or allow the tablet to dissolve in their mouths because of a potential for oropharyngeal ulceration.
Section 4.4
Due to the positive effects of alendronate in increasing bone mineral, decreases in serum calcium and phosphate may occur especially in patients taking glucocorticoids in whom calcium absorption may be decreased.
Section 4.5
Since NSAID use is associated with gastrointestinal irritation, caution should be used during concomitant use with alendronate.
Section 4.7
However, certain adverse reactions that have been reported with FOSAVANCE may affect some patients' ability to drive or operate machinery. Individual responses to FOSAVANCE may vary (see section 4.8). However, there is no information to indicate that FOSAVANCE affects a patient’s ability to drive or operate machines.
Section 4.8:
Nervous system disorders: dizziness, dysgeusia
Updated on 21 May 2009
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.4: Addition of new paragraph in relation to stress fractures.
Section 4.8:
Inclusion of stress fractures to side effects as follows: Musculoskeletal, connective tissue and bone disorders: stress fractures of the proximal femoral shaft
Updated on 18 December 2008
Reasons for updating
- Improved electronic presentation
Updated on 28 October 2008
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 05 September 2008
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The changes relate to addition of alopecia in section 4.8
Updated on 05 September 2008
Reasons for updating
- Change to side-effects
Updated on 31 July 2008
Reasons for updating
- Change to marketing authorisation holder address
Updated on 03 January 2008
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Also update section 4.4 (add reference to periodontal disease).
Updated on 03 January 2008
Reasons for updating
- Change of trade or active ingredient name
- Change to warnings or special precautions for use
Updated on 02 November 2007
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Update section 4.4 to reflect periodontal reference.
Updated on 17 May 2007
Reasons for updating
- Change to improve clarity and readability
- Change to side-effects
- Change to drug interactions
Updated on 21 December 2006
Reasons for 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
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 31 October 2005
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 30 September 2005
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 30 September 2005
Reasons for updating
- New PIL for new product