FOSAVANCE *

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 10 May 2021

File name

QRD-IE-MT-FOSAVANCE-4 TAB-LFT-WRM__1620635226.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_1620635082.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_1600954912.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_1600954704.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_1533294367.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_1533294266.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

The two SPC strengths have been combined into one SPC. Editorial changes have also been made.

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

Renewal - Changes to sections: 2, 4.2 4.6, 4.7, 4.8, 5.1 6.6 and 10 Also editorial /formatting changes to sections 4.2, 4.3, 4.4, 4.5, 4.9, 5.2, 6.1, & 9

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

4.7 Effects on ability to drive and use machines - Type II variation to amend section 4.7

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

Articles 20 & 31 referrals regarding  Bisphosphonates

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

Type II variation to amend section 4.8 undesirable effects

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 has been reported in patients treated by bisphosphonates. The majority of the reports refer to cancer patients, but such cases have also been reported in patients treated for osteoporosis Osteonecrosis of the jaw is generally associated with tooth extraction and / or local infection (including osteomyelitis). Diagnosis of cancer, chemotherapy, radiotherapy, corticosteroids, and poor oral hygiene and smoking are also deemed as risk factors (see section 4.4); joint swelling; stress fractures of the proximal femoral shaft (see section 4.4)

 

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 side-effects

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 31 July 2008

Reasons for updating

  • Change to marketing authorisation holder address

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 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

Changes relate to section 1 (change in name (add units)).
 Also update section 4.4 (add reference to periodontal disease).

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

Sections 4.4 and 4.8 updated to include the findings of PhVWP class review on bisphosphonates and osteonecrosis.
Section 4.8 updated to include additional AEs.

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