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Nasonex 50 micrograms/actuation Nasal Spray, Suspension

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Pharmacy Only: Prescription

Updated on 30 March 2023

File name

QRD-Nasonex PIL IE MT Heist nov 22 CRT.pdf

Reasons for updating

  • Change to name of manufacturer

Updated on 31 January 2023

File name

Nasonex-SE-H-1821-01-MAT Oct21 SPC IE-en-CRT.pdf

Reasons for updating

  • Document format updated

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

Updated on 14 October 2021

File name

Nasonex-SE-H-1821-01-MAT Oct21 SPC IE-en-CRT.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 14 October 2021

File name

Nasonex MAT PIL IE MT CRT.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 07 April 2020

File name

Nasonex IB-77 QRD PIL CRT (002).pdf.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 07 April 2020

File name

Nasonex IB-77 SmPC CRT (002).pdf.pdf

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

  1. Update warning to the excipient benzalkonium chloride in line with latest guideline and updated HPRA AE reporting address.

Updated on 25 June 2019

File name

NASONEX-UK-H-0196-001-IB-072G-SPC-IE-en-CRT.pdf

Reasons for updating

  • Improved presentation of SPC

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

Free text change information supplied by the pharmaceutical company

 Converted the SPC from word format to pdf file format 

 

Updated on 20 December 2017

Reasons for updating

  • New SPC for new product

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

Updated on 20 December 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.4 & 4.8 Visual disturbances as a side effect of unknown frequency

Updated on 19 December 2017

File name

PIL_14543_17.pdf

Reasons for updating

  • New PIL for new product

Updated on 19 December 2017

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

Updated on 31 May 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Co-treatment with CYP3A inhibitors including cobicistat

Updated on 30 May 2017

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 24 June 2016

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

Shelf life increased to 3 years

Updated on 23 June 2016

Reasons for updating

  • Change to storage instructions

Updated on 23 July 2015

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Free text change information supplied by the pharmaceutical company

SPC sections have changed: Change to Section 2 - Qualitative and quantitative composition, 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 4.6 - Pregnancy and lactation, Change to Section 4.8 - Undesirable effects, Change to Section 5.1 - Pharmacodynamic properties, Change to Section 5.2 - Pharmacokinetic properties, Change to Section 5.3 - Preclinical safety data, Change to Section 6.1 - List of excipients, Change to Section 6.6 - Special precautions for disposal and other handling

Detailed SPC change information: Brief outline of changes to SPC sections listed above

Updated on 22 July 2015

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to dosage and administration

Updated on 21 March 2013

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

Change to Section 7: Marketing authorisation holder - Change to address of MAH Ireland 

Updated on 10 September 2012

Reasons for updating

  • Change to section 4.9 - Overdose
  • 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 4.9
Update to bioavailability data
 
Section 5.2
Update to pharmacokinetic information generated by the completed study P05002

Updated on 05 March 2012

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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

Free text change information supplied by the pharmaceutical company

Change to Section 4.4 - Special warnings and precautions for use.
Addition of warnings and precautions concerning the risk of psychiatric adverse drug reactions to inhaled and intranasal corticosteroids and risk of non-psychiatric systemic adverse drug reactions to intranasal corticosteroids

Updated on 02 March 2012

Reasons for updating

  • Change to side-effects

Updated on 15 November 2011

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

Section 4.8: Addition of side effects - nasal septum perforation and glaucoma and cataracts    

Updated on 15 November 2011

Reasons for updating

  • Change to side-effects

Updated on 22 September 2011

Reasons for updating

  • Change to dosage and administration

Updated on 27 January 2011

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Due to a company merger the licence is now held by Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK. The SmPC now reflects this.

Updated on 26 January 2011

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 25 January 2010

Reasons for updating

  • New PIL for medicines.ie

Updated on 16 September 2008

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 4.2 - changes to priming instructions in first and last paragraphs
 
Section 10 - updated date of revision of text.

Updated on 08 April 2008

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 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

 Section 2 - the following has been added

"This medicinal product contains 0.2mg of benzylkonium chloride per gram."

The following sentence changed from:

"For excipients, see 6.1"

to:

"For full list of excipients, see section 6.1"

Section 4.2 - Nasal Polyposis

The following sentence has been removed from this section:

"the dose should be reduced following control of symptoms"

and replaced with the following:

"The dose should be titrated to the lowest dose at which effective control of symptoms is maintained."

Section 6.1

"Sodium citrate dihydrate" has been changed to "sodium citrate"

Section 9 - Date of renewal of authorisation has been updated

Section 10 - date of revision of text has been updated

Updated on 13 November 2007

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic 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 4.8


After Table 2, the following paragraph has been added:

 

In patients treated for acute rhinosinusitis,  the incidence of epistaxis for NASONEX was 3.3% vs. 2.6% for placebo and similar to that observed for patients treated with allergic rhinitis.

Section 5.1

 

The following paragraph has been added to this section:

 

In two trials with  1954 patients, Nasonex Nasal Spray 200 mcg administered twice daily demonstrated significant improvement in symptoms associated with acute rhinosinusitis compared to placebo as evaluated by the Major Symptom Score (MSS) composite of symptoms (facial pain/pressure/tenderness, sinus headache, rhinorrhea, post nasal drip, and nasal congestion/stuffiness) during the 15 day treatment period (P02683 p < 0.001; P02692 p = 0.038). A 500 mg three times a day amoxicillin arm was not significantly different from placebo in reducing these symptoms of acute rhinosinusitis as evaluated by the MSS.  The SNOT-20 HRQL showed a significant level of benefit at the 200 mcg twice daily dose of mometasone furoate vs. placebo (p=0.047).  Treatment duration beyond 15 days was not evaluated in acute rhinosinusitis.

Section 10

 

The date of revision of text has been revised

Updated on 14 May 2007

Reasons for updating

  • Change to section 6.1 - List of excipients
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 6.1
 
Phenylethyl alcohol removed from formulation
 
Section 6.4
 
From: Do not store above 30°C.  Do not freeze.
To: Do not store above 25°C.  Do not freeze.
 
Section 10 - date of revision of text updated

Updated on 10 May 2007

Reasons for updating

  • Change to section 6.1 - List of excipients
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 6.1
 
Phenylethyl alcohol removed from formulation
 
Section 6.4
 
From: Do not store above 30°C.  Do not freeze.
To: Do not store above 25°C.  Do not freeze.
 
Section 10 - date of revision of text updated

Updated on 29 June 2006

Reasons for updating

  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 6.5: addition pack sizes added
 
Section 9 - Date of revision of text

Updated on 21 February 2005

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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

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

Updated on 28 May 2003

Reasons for updating

  • New SPC for medicines.ie

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