Singulair 10mg Film-coated Tablets
- Name:
Singulair 10mg Film-coated Tablets
- Company:
MSD Ireland (Human Health) Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 26/05/20
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MSD Ireland (Human Health) Limited
Company Products
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 26 May 2020
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Updated on 26 May 2020 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 15 January 2020
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
- Section 2 addition of the following sentence: ‘Excipient with known effect: This medicine contains less than 1 mmol sodium (23 mg) per sachet, that is to say essentially ‘sodium-free’.
- Section 4.8: Addition of the following sentence: ‘obsessive-compulsive symptoms’.
- Section 10: ‘Date of revision of text updated to ‘December 2019’.
Updated on 15 January 2020 PIL
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
- Change to section 2 : ‘Singulair contains sodium’. This medicine contains less than 1 mmol sodium (23 mg) per sachet, that is to say essentially ‘sodium-free’.
- Change to section 4 - possible side effects: Very rare: behaviour and mood related changes: obsessive-compulsive symptoms
- Change to section 6 – other: Authorization of medicinal product: 1 country removed
- Change to section 6 - date of revision: New Date of Revision
Updated on 18 June 2019
Reasons for updating
- Improved presentation of SmPC
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
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
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 SPC
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 SPC
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 20 April 2015 PIL
Reasons for updating
- Change to MA holder contact details
Updated on 21 October 2014 PIL
Reasons for updating
- Change to side-effects
Updated on 21 August 2014 SPC
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
Updated on 1 November 2013 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 8 July 2013 SPC
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 SPC
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 SPC
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 SPC
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
Updated on 25 July 2011 SPC
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 SPC
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 SPC
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 SPC
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 SPC
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 SPC
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 on 3 July 2008 PIL
Reasons for updating
- Change to side-effects
Updated on 21 February 2008 SPC
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 SPC
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 SPC
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
Updated on 10 July 2006 PIL
Reasons for updating
- Change to drug interactions
Updated on 10 July 2006 SPC
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
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 2 May 2006 SPC
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 SPC
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 SPC
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 SPC
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 16 August 2005 PIL
Reasons for updating
- Change to drug interactions
- Change to side-effects
Updated on 1 March 2005 SPC
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 SPC
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 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)