Dymista Nasal Spray *
Pharmacy Only: Prescription

Updated on 07 April 2022

File name

ie-pl-de3355-v040-clean_1649317211.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 07 December 2020

File name

ie-spc-de3355-v035v038-clean_1607358601.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)

Updated on 07 December 2020

File name

ie-pl-de3355-v038-clean-rtq_1607358559.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 14 August 2020

File name

ie-spc-de3355-v035-clean_1597418833.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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 be renewed (B)

Updated on 28 May 2019

File name

ie-pl-de3355-art613andmahtransfer-clean_1559038560.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 05 March 2019

File name

PIL_15793_521.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 05 March 2019

File name

ie-spc-de3355-mahtransfer-clean_1551803637.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

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

Updated on 29 May 2018

File name

Dymista_Nasal_Spray_SmPC_May_2018.docx

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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

In section 6.3: change in shelf-life

In section 10: date of revision changed

Updated on 09 November 2017

Reasons for updating

  • New SPC for new product

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

Updated on 09 November 2017

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • 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

In section 6.4: The shelf-life of 6.4g presentation has been extended to 1 year
In section 10: The date of revision has changed

Updated on 21 July 2017

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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

In section 4.5: Information added  regarding co-treatment with other CYP 3A4 inhibitors, and expectancy to increase the risk of systemic side-effects.

In section 10: Date of revision changed.

Updated on 27 June 2017

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

In section 4.4: Information regarding visual disturbance has been added.

In section 4.8: Blurred vision has been added to undesirable effects with frequency of not known

In section 10: The date of revision has been changed.

Updated on 18 August 2015

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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

In section 6.3: reduction of shelf-life for the 23g pack size
In section 10: date of revision has changed

Updated on 27 January 2015

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

In section 4.8: Adverse reaction reporting statement has been added

In section 10: date of revision has changed

 

Updated on 24 October 2014

Reasons for updating

  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

Section 4.1: the spelling for glucocorticoid was wrong and this is now corrected

Updated on 11 July 2013

File name

PIL_15793_521.pdf

Reasons for updating

  • New PIL for new product

Updated on 17 April 2013

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided