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Merck Sharp & Dohme Ireland (Human Health) Limited
Pelham House, South County Business Park, Leopardstown, Dublin 18, Ireland
Telephone: +353 1 299 8700
Fax: +353 1 299 8701
Medical Information e-mail: medinfo_ireland@merck.com
Summary of Product Characteristics last updated on medicines.ie: 26/08/2011
SPC Singulair Paediatric 4 mg Chewable Tablets

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 26/08/2011 and displayed until Current
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   13-Jul-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Correction of minor typos
Updated on 25/07/2011 and displayed until 26/08/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   01-Jul-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


Updated side effects
Updated on 16/11/2010 and displayed until 25/07/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   01-Nov-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


Sections 4.8, 5.1 - Updated side effects

 
Updated on 01/09/2010 and displayed until 16/11/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   02-Aug-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


Updated side effects - Section 4.8

 
Updated on 17/11/2009 and displayed until 01/09/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   30-Sep-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


Approval of II/49 (update to 4.8 of SPC)
Addition of side effects: epistaxis/pyrexia

 
Updated on 01/12/2008 and displayed until 17/11/2009
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   10/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 4.8 has been updated to include anxiety.
Updated on 29/10/2008 and displayed until 01/12/2008
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   10/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
The changes are as a result of a variation to implement a commission decision on an article 30 referral.
Changes have been made to the following sections: 3, 4.1, 4.2, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1, 6.6.
Updated on 03/07/2008 and displayed until 29/10/2008
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   04/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Amend section 4.8 Undesirable effects
Updated on 21/02/2008 and displayed until 03/07/2008
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   02/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

The changes to the SPC are to Section 4.8 Undesirable Effects which has been amended to include tremor and depression .
Updated on 21/02/2008 and displayed until 21/02/2008
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   02/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

The changes to the SPC are to Section 4.8 Undesirable Effects which has been amended to include tremor and depression .
Updated on 09/01/2008 and displayed until 21/02/2008
Reasons for adding or updating:
  • New individual SPC (was previously included in combined SPC)
Date of revision of text on the SPC:   12/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 4.8 has been updated.
Updated on 12/02/2007 and displayed until 09/01/2008
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and lactation
Date of revision of text on the SPC:   11/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Change to upsate section 4.6 Preganancy  and lactation
Updated on 10/07/2006 and displayed until 12/02/2007
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   06/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
 
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.
Updated on 02/05/2006 and displayed until 10/07/2006
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Montelukast Sodium