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Nasacort Nasal Spray

  • Name:

    Nasacort Nasal Spray

  • Company:
    info
  • Active Ingredients:

    Triamcinolone Acetonide

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 04/11/20

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Summary of Product Characteristics last updated on medicines.ie: 6/5/2020

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1 - 0 of 174 items.Total: Infinity pages

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 4 November 2020 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 3 August 2020 PIL

Reasons for updating

  • XPIL Removed

Updated on 6 May 2020 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - use in children and adolescents
  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 6 May 2020

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
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Sections 4.1, 4.2, 4.4, 4.8, 5.1, 5.2 &10 of the SPC have been updated

Updated on 12 May 2018

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

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

Updated on 11 December 2017

Reasons for updating

  • New SmPC for new product

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

Updated on 11 December 2017 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4 added:-

Visual disturbance

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

 

Section 4.8 added:

Eye disorders

blurred vision

Updated on 8 December 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 8 December 2017 PIL

Reasons for updating

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

Updated on 2 August 2016 SPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

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

Free text change information supplied by the pharmaceutical company

Word changes- 'dust' replaced with cap

Updated on 1 August 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 15 May 2014 SPC

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 4.6 - 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • 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 4.2 - note of reference added (see sections 4.4 & 5.1)
Section 4.4 - the warning on 'reduction of growth velocity' has been modified
Section 4.8 - adverse event on 'reduction of growth velocity' and adverse event reporting included
Section 5.1 - inclusion of new study data

All other sections updated in line with the Quality Review Document with minor editoral changes.

Updated on 12 May 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects

Updated on 11 September 2012 SPC

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

Section 7 updated to include 'Sanofi' as a trading style

Updated on 7 September 2012 PIL

Reasons for updating

  • Change of licence holder

Updated on 16 August 2010 SPC

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 Special Warning and precautions for use - addition of warning on the long term effects in growth velocity associated with nasal corticosteroids.
Addition of warning of reports of glaucoma and/or cataracts in patients receiving nasal corticosteroids
 
Section 4.8: Undesirable effects - post-marketing adverse events added

Updated on 28 May 2008 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 23 August 2007 SPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • 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: Added excipient detail re benzalkonium chloride
Section 4.2: Insructions for use and cleaning instructions moved from Section 6.6
Section 6.1: Excipients listed as bullet points rather than sentence format
Section 6.2: Incompatabilities changed from 'none known' to 'not applicable'
Section 6.3: Editorial change to summarise shelf life under sub-headings 'Unopened' and 'After first opening'
Section 6.6: Moved instructions for use and cleaning instructions to section 4.2, inserted 'No special requirements'
Section 7: Changed MA holder from Aventis Pharma Ltd to sanofi-aventis Ireland Ltd
Section 9: Added subheadings 'date of first authorisation' and 'date of last renewal', added date of last renewal as 19 January 2007
Section 10: Changed to July 2007

Updated on 19 December 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 6 December 2005 SPC

Reasons for updating

  • Change to section 6.6 - Special precautions for disposal and other handling

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

Updated on 16 August 2005 SPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 2 March 2005 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 28 February 2005 SPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

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

Updated on 19 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 10 June 2003 SPC

Reasons for updating

  • New SPC for medicines.ie

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