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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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 4.1 - Therapeutic indications
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Change to section 4.2 - Posology and method of administration
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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: 02-Mar-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.1
Addition of age groups in the indications section.
Section 4.2
Recommendation to evaluate response after 2-4 weeks and that the granules formulation is not recommended below 6 months of age.
Addition of information on the use of Singulair as prophylaxis of asthma for 2 to 5 year old patients in whom the predominant component is exercise-induced bronchoconstriction.
Section 4.4
The sentence "The diagnosis of persistent asthma in very young children (6 months – 2 years) should be established by a paediatrician or pulmonologist." has been added.
Section 4.8
Addition of anxiety as a side effect.
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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 19/09/2007 and displayed until 07/12/2007
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Correction of spelling/typing errors
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Updated on 22/11/2006 and displayed until 19/09/2007
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 6. 3 - Shelf Life
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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. The shelf life for Singulair Granules has also been updated to 3 years.
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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 04/05/2006 and displayed until 07/07/2006
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 02/05/2006 and displayed until 04/05/2006
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic Indications
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Change to section 4.2 - Posology and Method of Administration
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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: 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 the new 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 added from new studies relevant to the new indication.
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Updated on 30/01/2006 and displayed until 02/05/2006
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 27/01/2006 and displayed until 30/01/2006
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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 4.8 - Undesirable Effects
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Updated on 19/04/2004 and displayed until 27/01/2006
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 18/03/2004 and displayed until 19/04/2004
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Reasons for adding or updating:
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Correction of spelling/typing errors
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New SPC for new product
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Updated on 01/03/2004 and displayed until 18/03/2004
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