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Quofenix 450 mg tablets

  • Name:

    Quofenix 450 mg tablets

  • Company:
    info
  • Active Ingredients:

    Delafloxacin Meglumine

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 07/04/21

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Summary of Product Characteristics last updated on medicines.ie: 7/4/2021
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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A. Menarini Pharmaceuticals Ireland Ltd

A

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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 7 April 2021 SPC

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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.1 - Addition of new indication - community-acquired pneumonia (CAP)

Section 4.2 - New information added for CAP

Section 4.4 - Limitations of the clinical data section updated to include information on CAP

Section 4.8 - New information added for CAP and frequencies updated

Section 5.1 - Section updated with new info on CAP

Section 5.2 - New information added for distribution 

Section 10 - Date of revision updated

Updated on 7 April 2021 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Change to section 1 - Addition of new Indication - Pneumonia

Change to section 3 - How to use Quofenix - new details added for Pneumonia

Change to section 4 - Section updated with new and updated information around frequencies 

Change to section 4 - Date of revision updated

Updated on 3 December 2020 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

PIL

The changes relate to the requested actions following the PRAC recommendation concerning the signal of “heart valve regurgitation, cervical artery dissection and aortic aneurysm and dissection” associated with Fluoroquinolones intake.

 

The following sections are updated:

2.         What you need to know before you take Quofenix

Warnings and precautions

…Talk to your doctor or pharmacist or nurse before taking Quofenix if:

 

4.         Possible side effects

 

Updated on 3 December 2020 SPC

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

The changes relate to the requested actions following the PRAC recommendation concerning the signal of “heart valve regurgitation, cervical artery dissection and aortic aneurysm and dissection” associated with Fluoroquinolones intake.

 The following sections are updated:

Section 4.4     Special warnings and precautions for use

 [..] 

Aortic dissection and aneurysm, and heart valve regurgitation/incompetence

Further information added.

 

Section 4.8     Undesirable effects

Cardiac disorders** 

Vascular disorders**   

 

** Cases of aortic aneurysm and dissection, sometimes complicated by rupture (including fatal ones), and of regurgitation/incompetence of any of the heart valves have been reported in patients receiving fluoroquinolones (see section 4.4).

Updated on 28 May 2020 SPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 28 May 2020 PIL

Reasons for updating

  • New PIL for new product