Singulair 10mg Film-coated Tablets

  • Name:

    Singulair 10mg Film-coated Tablets

  • Company:
    info
  • Active Ingredients:

    Montelukast Sodium

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 10/08/18

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Summary of Product Characteristics last updated on medicines.ie: 18/6/2019

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MSD Ireland (Human Health) Limited

MSD Ireland (Human Health) Limited

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1 - 0 of 84 items.Total: Infinity pages

When a pharmaceutical company changes any document, 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 18 June 2019 SmPC

Reasons for updating

  • Improved presentation of SmPC

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Converted the SPC from word document to pdf file format 

 

Updated on 10 August 2018 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 14 June 2018 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to section 4.8 ( addition of the following adverse events: enuresis in children; thrombocytopenia; uncontrolled muscle movement)

Updated on 14 June 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 7 March 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 7 March 2016 PIL

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability

Updated on 4 March 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 4 March 2016 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Sections that have changed:  Change to Section 4.4 - Special warnings and precautions for use, Change to Section 10 - Date of revision of the text

SPC change details:   The SPC has been revised to:  1)  to update the current wording regarding the Churg-Strauss Syndrome (CSS) in section 4.4;  2)  reflect the current QRD version

Updated on 20 April 2015 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 20 April 2015 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 7 – Merck Sharp & Dohme Ireland (Human Health) Ltd., Red Oak North, South County Business Park, Leopardstown, Dublin 18

Section 8 – PA 1286/046/004

Section 10 – last revision date change to March 2015 

Updated on 21 October 2014 PIL

Reasons for updating

  • Change to side-effects

Updated on 21 August 2014 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Sections 4.2, 4.4, 4.8, 10

Updated on 1 November 2013 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 8 July 2013 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Updates to Sections: 4.8, 10

Updated on 7 January 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 6 December 2012 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Detailed SPC change information: Update regarding interactions with CYP 2C8 inhibitors

Updated on 23 July 2012 PIL

Reasons for updating

  • Change to side-effects

Updated on 24 April 2012 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Updates to Sections 4.8 and 10.
Added side effects: disorientation and erythema multiforme (very rare)

 

Updated on 12 October 2011 PIL

Reasons for updating

  • Change to side-effects

Updated on 26 August 2011 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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 July 2011 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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 1 September 2010 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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 21 July 2010 PIL

Reasons for updating

  • Change to side-effects

Updated on 13 November 2009 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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)
4.8 Addition of side effects: epistaxis/pyrexia

 

Updated on 10 November 2009 PIL

Reasons for updating

  • Change to side-effects

Updated on 27 August 2009 PIL

Reasons for updating

  • Change to side-effects

Updated on 1 December 2008 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.8 has been updated to include anxiety.

Updated on 1 December 2008 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.8 has been updated to include anxiety.

Updated on 3 July 2008 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Amend section 4.8 Undesirable effects

Updated on 3 July 2008 PIL

Reasons for updating

  • Change to side-effects

Updated on 21 February 2008 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

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 9 January 2008 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.8 has been updated.

Updated on 13 February 2007 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Chnage to section 4.6 Pregnancy and Lactation

Updated on 10 July 2006 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.9 - Overdose

Legal category: Product subject to medical prescription which may be renewed (B)

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 10 July 2006 PIL

Reasons for updating

  • Change to drug interactions

Updated on 2 May 2006 SmPC

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 25 November 2005 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 2 November 2005 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 16 August 2005 PIL

Reasons for updating

  • Change to drug interactions
  • Change to side-effects

Updated on 16 August 2005 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 1 March 2005 SmPC

Reasons for updating

  • 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 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 1 March 2005 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to side-effects
  • Change to warnings or special precautions for use

Updated on 16 November 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 21 January 2004 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.4 - Special precautions for storage

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 19 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)