Summary of Product Characteristics
last updated on the eMC:
22/08/2011
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 22/08/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 11-Aug-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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The change was to re-structure section 4.8 of the SmPC by placing the post-marketing adverse reactions in a table and providing a frequency category for each. There were no additional Adverse reactions added.
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Updated on 06/12/2010 and displayed until 22/08/2011
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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 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 11-Nov-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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To section 4.8. "Undesirable Effects", the following has been added:
"Montelukast has been evaluated in a clinical study in patients with intermittent asthma as follows:
4 mg granules and chewable tablets in 1038 paediatric patients 6 months to 5 years of age "
In section 5.1 "pharmacodynamics" the following has been added:
"In a placebo-controlled study in paediatric patients 6 months to 5 years of age who had intermittent asthma but did not have persistent asthma, treatment with montelukast was administered over a 12-month period, either as a once-daily 4 mg regimen or as a series of 12-day courses that each were started when an episode of intermittent symptoms began. No significant difference was observed between patients treated with montelukast 4 mg or placebo in the number of asthma episodes culminating in an asthma attack, defined as an asthma episode requiring utilization of health-care resources such as an unscheduled visit to a doctor's office, emergency room, or hospital; or treatment with oral, intravenous, or intramuscular corticosteroid."
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Updated on 02/07/2010 and displayed until 06/12/2010
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 03-Jun-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.8: Addition of adverse reactions (hostility, somnambulism, upper respiratory infection).
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Updated on 07/09/2009 and displayed until 02/07/2010
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 14-Aug-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Addition of adverse reactions (epistaxis and pyrexia) in section 4.8 of the SmPC
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Updated on 23/03/2009 and displayed until 07/09/2009
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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):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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