Frovex *

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 14 July 2021

File name

Frovex SPC Clean Approved June 21_1626273310.pdf

Reasons for 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
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • 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

Section 4.4 - Excipient warnings updated

Section 4.8 - HPRA reporting details updated

Section 6.3 - Details on bottle pack deleted

Section 6.4 - Details on bottle pack deleted

Section 6.5 - Bottle pack deleted and blister pack details updated 

Section 10 - Date or revision updated 

Updated on 14 July 2021

File name

Frovex PIL Clean Approved June 21_1626273051.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
  • Change to other sources of information section

Free text change information supplied by the pharmaceutical company

Section 2 - Sodium excipient warning added

Section 4 - HPRA reporting details updated

Section 5 - How to store - details on bottle pack deleted 

Section 6 - details on blister packs updated 

Section 6 - Date of revision updated 

Changes to other information - product names in other member states updated

 

Updated on 01 August 2019

File name

PIL_7922_985.pdf

Reasons for updating

  • XPIL Created

Updated on 01 August 2019

File name

ie-spc Frovex approved 14-8-17 clean_1564671289.pdf

Reasons for updating

  • File format updated to PDF

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

File format updated to pdf

Updated on 02 May 2019

File name

PIL_7922_985.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 24 August 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 24 August 2017

File name

PIL_7922_985.pdf

Reasons for updating

  • New PIL for new product

Updated on 24 August 2017

Reasons for 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 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
  • Improved presentation of SPC

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The SmPC has been updated to align to the latest QRD template.

Updated on 24 August 2017

Reasons for updating

  • Improved presentation of PIL

Updated on 18 December 2014

Reasons for updating

  • Change of contraindications
  • Change to storage instructions
  • Addition of information on reporting a side effect.

Updated on 04 December 2014

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • 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 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 8 - MA number
  • 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



Administrative amendments (to align to the current QRD template)

Sections 2, 3, 4.1, 4.2, 4.3, 4.5, 4.6, 5.2, 6.1, 6.4, 6.6, 8.

 

Section 4.4 Special warnings and precautions for use

Warning on hypersensitivity added.

 

Section 4.8 Undesirable effects

Adverse reactions collected in the post-marketing experience - hypersensitivity reactions (including cutaneous disorders, angioedema and anaphylaxis); myocardial infarction and arteriospasm coronary added under ‘not known’ category.

 

Reporting of side-effects details added.

 

Section 10 Date of revision of the text

Updated to November 2014

Updated on 04 December 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 17 December 2013

Reasons for updating

  • Change to date of revision

Updated on 17 September 2009

Reasons for updating

  • Addition of manufacturer

Updated on 18 November 2008

Reasons for updating

  • Change to side-effects

Updated on 19 August 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


Update to section 4.8 - adverse event table

Updated on 08 November 2007

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.9 - Overdose
  • Change to section 6.1 - List of excipients
  • 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

Section 2 – Include excipient details for lactose

Sections 4.4 - Update warning on prolonged use of painkillers for headaches, add reference to lactose.

Section 4.9 – Update information on overdose

Section 6.1 – Update details for the film coat (Macrogel 3000)

Sections 9 and 10 – Update date of renewal and revision of the text

Updated on 08 November 2007

Reasons for updating

  • Change due to user-testing of patient information
  • Change due to harmonisation of patient information leaflet

Updated on 20 March 2007

Reasons for updating

  • Change to name of manufacturer

Updated on 09 May 2006

Reasons for updating

  • Change of manufacturer

Updated on 29 March 2005

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 10 August 2004

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 05 August 2004

Reasons for updating

  • New PIL for new product