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 02/07/2010 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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| 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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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 02-Feb-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Addition of anxiety as a side effect in section 4.8
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Updated on 06/08/2008 and displayed until 23/03/2009
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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 6. 5 - Nature and Contents of Container
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| Date of revision of text on the SPC: 01-Jul-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.8 Undesirable Effects: under the sub-section " Psychiatric disorders" the following has been added:
suicidal thinking and behaviour (suicidality) in very rare cases
Also in section 4.8, but under the sub-section "Skin and subcutaneous tissue disorders" the following has been added :
erythema nodosum
Section 6.5 Nature and Contents of Container: The days of the week are no longer included on the blister foil and reference to this has been removed from the SPC.
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Updated on 07/12/2007 and displayed until 06/08/2008
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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: 11/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Two additional side effects 'tremor' and 'depression' have been added in section 4.8.
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Updated on 22/11/2006 and displayed until 07/12/2007
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Reasons for adding or updating:
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Change to section 4.6 - Pregnancy and Lactation
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| Date of revision of text on the SPC: 11/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.6 has been updated with worldwide post marketing experience. In summary, pregnancy and lactation information is now detailed under individual subheadings. Limited pregnancy data do not suggest causal relationship between ‘Singular’ and limb defect malformations that have been rarely reported. Studies in rats show montelukast is excreted in milk. Not known if excreted in human milk. ‘Singulair’ may be used during pregnancy and in nursing mothers only if considered clearly essential.
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Updated on 07/07/2006 and displayed until 22/11/2006
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Reasons for adding or updating:
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 4.9 - Overdose
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| Date of revision of text on the SPC: 06/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.5: Previously included a caution on inhibition of drugs metabolised by CYP 2C8 (eg. paclitaxel, rosiglitazone, and repaglinide) but that no in vivo interaction studies had been performed.
New information is now available from an interaction study and the statement has been revised to the following
However, data from a clinical drug-drug interaction study involving montelukast and rosiglitazone (a probe substrate representative of drugs primarily metabolised by CYP 2C8) demonstrated that montelukast does not inhibit CYP 2C8 in vivo. Therefore, montelukast is not anticipated to markedly alter the metabolism of drugs metabolised by this enzyme (eg., paclitaxel, rosiglitazone, and repaglinide)'.
Section 4.9:
Mainly editorial changes and updated in line with post-market reports and most frequently occurring AEs consistent with montelukast safety profile. Some AE terminology re-defined. Previously: thirst, somnolence, mydriasis, hyperkinesia, abdominal pain.
Now: abdominal pain, somnolence, thirst, headache, vomiting, and psychomotor hyperactivity.
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Updated on 02/05/2006 and displayed until 07/07/2006
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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: 09/03/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| This SPC was previously presented in combination with the 4 and 5 mg paediatric information. Now it is for the 10 mg tablets alone.
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