Nasonex 50 micrograms/actuation Nasal Spray, Suspension
- Name:
Nasonex 50 micrograms/actuation Nasal Spray, Suspension
- Company:
MSD Ireland (Human Health) Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 07/04/20
(Click to Download)Click on this link to Download PDF directly
MSD Ireland (Human Health) Limited
Company Products
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 2020 PIL
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 7 April 2020 SmPC
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
- Update warning to the excipient benzalkonium chloride in line with latest guideline and updated HPRA AE reporting address.
Updated on 25 June 2019 SmPC
Reasons for updating
- Improved presentation of SmPC
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 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 20 December 2017 SmPC
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
Updated on 19 December 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 19 December 2017 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
Updated on 31 May 2017 SmPC
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
Updated on 30 May 2017 PIL
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 SmPC
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
Updated on 23 June 2016 PIL
Reasons for updating
- Change to storage instructions
Updated on 23 July 2015 SmPC
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 PIL
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 SmPC
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
Updated on 10 September 2012 SmPC
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
Updated on 5 March 2012 SmPC
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 2 March 2012 PIL
Reasons for updating
- Change to side-effects
Updated on 15 November 2011 SmPC
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
Updated on 15 November 2011 PIL
Reasons for updating
- Change to side-effects
Updated on 22 September 2011 PIL
Reasons for updating
- Change to dosage and administration
Updated on 27 January 2011 SmPC
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
Updated on 26 January 2011 PIL
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder
Updated on 25 January 2010 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 16 September 2008 SmPC
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
Updated on 8 April 2008 SmPC
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
"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 SmPC
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 SmPC
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
Updated on 10 May 2007 SmPC
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
Updated on 29 June 2006 SmPC
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
Updated on 21 February 2005 SmPC
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 SmPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may not be renewed (A)