Summary of Product Characteristics
last updated on the eMC:
08/05/2012
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 08/05/2012 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 4.8 - Undesirable Effects
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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: 18-Apr-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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A request from the MHRA regarding a decision taken by the Pharmacovigilance Working Party (PhVWP) relating to risk of psychiatric adverse drug reactions to inhaled and intranasal corticosteroids and risk of non-psychiatric systemic adverse drug reactions to intranasal corticosteroids has resulted in changes suggested by the PhVWP to our SmPC and PIL where relevant. sections affected include:
4.4 Special warnings and precautions for use
Systemic effects of inhaled 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. Possible systemic effects may include Cushing’s syndrome. Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataracts, and glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children). Therefore, it is important that the dose of inhaled corticosteroid is titrated to the lowest dose at which effective control of asthma is maintained.
4.8 Undesirable effects
"Psychiatric disorders: Psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression" has been added to table 1 Treatment-related undesirable effects seen in clinical trials and post-marketing reporting with a frequency of 'not known'
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Updated on 06/06/2011 and displayed until 08/05/2012
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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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: 14-May-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 4.8 changes:
Removal of the following sentence: There was no suggestion of an increased risk of undesirable effects in adolescents or patients 65 years of age or older.
Also the adverse event dysphonia has been relocated in the table and can now be found under the heading -
Respiratory, thoracic and mediastinal disorders
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Updated on 22/03/2011 and displayed until 06/06/2011
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Reasons for adding or updating:
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New individual SPC (was previously included in combined SPC)
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| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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