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Schering-Plough Ltd
Schering-Plough House, Shire Park, Welwyn Garden City, Herts, AL7 1TW
Telephone: +44 (0)1707 363 636
Medical Information e-mail: medical.info@spcorp.com
Medical Information Fax: +44 (0)1707 363 763
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Summary of Product Characteristics last updated on the eMC: 16/09/2008
SPC Nasonex 50 micrograms/actuation Nasal Spray, Suspension

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 16/09/2008 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   23-Aug-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2, first and last paragraphs - changes to priming instructions

Section 10 - date of revision of text updated
Updated on 28/03/2008 and displayed until 16/09/2008
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   03/2008
Legal Category:   POM
Black Triangle (CHM):   NO

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 19/11/2007 and displayed until 28/03/2008
Reasons for adding or 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
Date of revision of text on the SPC:   07/2007
Legal Category:   POM
Black Triangle (CHM):   NO

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 10/05/2007 and displayed until 19/11/2007
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Change to section 10 date of revision of the text
  • Change to section 6. 4 - Special Precautions for Storage
Date of revision of text on the SPC:   04/2007
Legal Category:   POM
Black Triangle (CHM):   NO

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 29/06/2006 and displayed until 10/05/2007
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   10/2005
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.5 - additional pack sizes.  Not all pack sizes may be marketed
Updated on 15/02/2005 and displayed until 29/06/2006
Reasons for adding or 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 (partial) revision of the text
Updated on 29/09/2004 and displayed until 15/02/2005
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Updated on 26/07/2002 and displayed until 29/09/2004
Reasons for adding or updating:
  • Change to section 1 - trade name
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 3 - pharmaceutical form
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instruction for Use/Handling
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text

Active Ingredients/Generics

 
  mometasone furoate


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