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sanofi-aventis

1 Onslow Street, Guildford, Surrey, GU1 4YS, UK
Telephone: +44 (0)1483 505 515
Fax: +44 (0)1483 535 432
Medical Information e-mail: uk-medicalinformation@sanofi-aventis.com

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Summary of Product Characteristics last updated on the eMC: 11/07/2011
SPC Nasacort Allergy Nasal Spray

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 11/07/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   23-Jun-2011
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



Following paragraph added under section 4.4:

 

Systemic effects of nasal corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids and may vary in individual patients and between different corticosteroid preparations. Potential systemic effects may include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).


section 10- date changed
Updated on 17/08/2010 and displayed until 11/07/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   23-Jul-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.4. - addition of warning about glaucoma and/or cataracts
Section  4.8 - addition of bronchitis, dyspepsia, epistaxis, cough and tooth disorders
Updated on 23/03/2009 and displayed until 17/08/2010
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

None provided

Active Ingredients/Generics

 
   triamcinolone acetonide