Summary of Product Characteristics
last updated on the eMC:
11/07/2011
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
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 10 date of revision of the text
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| 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
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| 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
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Updated on 17/08/2010 and displayed until 11/07/2011
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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| 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
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Section 4.4. - addition of warning about glaucoma and/or cataracts
Section 4.8 - addition of bronchitis, dyspepsia, epistaxis, cough and tooth disorders
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Updated on 23/03/2009 and displayed until 17/08/2010
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Reasons for adding or updating:
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| Date of revision of text on the SPC: |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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