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 09/09/2009 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 09/09/2009
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Reasons for adding or updating:
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Joint SPC superseded by SPCs for individual presentations
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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
Previous joint SPC for 4 and 5 mg tablets split into seperate ones
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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 6.1 - List of Excipients
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Change to section 6. 4 - Special Precautions for Storage
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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.
Section 6.1 List of excipients: Hydroxypropylcellulose has been changed to the EU name of hyprolose and the E number for Aspartame has been added.
Section 6.4 Special precautions for storage: The statement on storage has been amended to include "…in order to protect from light and moisture."
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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 23/11/2006 and displayed until 07/12/2007
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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 23/11/2006
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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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Section 4.1: Includes a new indication: ‘Singulair’ may also be an alternative treatment option to low-dose inhaled corticosteroids for patients with mild persistant asthma who do not have a recent history of serious asthma attacks that required oral corticosteroid use, and who have demonstrated that they are not capable of using inhaled corticosteroids (See section 4.2).
Section 4.2: A sub-section added under the heading: 'Singulair as an alternative treatment option to low-dose inhaled corticosteroids for mild persistent asthma ' , with further guidance on use in this population.
Revised text under the sub-section headed: 'Therapy with Singulair in relation to other treatments for asthma.'
Section 4.4 : A minor modification in line with text in section 4.2, to read: 'Montelukast should not be abruptly substituted for inhaler corticosteroids.'
Section 4.8: Information updated for paediatric studies and patient numbers.
Section 5.1: Results from new studies have been added relevant to the new indication.
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