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Singulair 10mg Film-coated Tablets

*
Pharmacy Only: Prescription

  • Company:

    Organon Pharma (Ireland) Limited

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Montelukast Sodium

    *Additional information is available within the SPC or upon request to the company

Updated on 05 July 2023

File name

QRD-IE-SINGULAIR-10mg-LFT-WS-112-CRT.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 05 July 2023

File name

SINGULAIR-10mg tabs-FI-H-0104-WS-0112-SPC- IE-en-CRT.pdf

Reasons for updating

  • New SPC for new product

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

Updated on 05 July 2023

File name

SINGULAIR-10mg tabs-FI-H-0104-WS-0112-SPC- IE-en-CRT.pdf

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

change to section 4.8

Updated on 29 March 2023

File name

QRD-IE-SINGULAIR-10mg-LFT-Heist Nov CRT.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to date of revision

Updated on 31 January 2023

File name

Singulair 10mg tabs-FI-H-0104-WS-086-SPC-MAT IE-CRT.pdf

Reasons for updating

  • Document format updated

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

Updated on 08 September 2021

File name

Singulair 10mg tabs-FI-H-0104-WS-086-SPC-MAT IE-CRT.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 08 September 2021

File name

QRD-IE-SINGULAIR-10mg-LFT-WS JULY2021 MAT CRT.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 08 September 2021

File name

QRD-IE-SINGULAIR-10mg-LFT-WS JULY2021 MAT CRT.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 07 September 2021

File name

SINGULAIR 10mg Tabs-FI-H-0104-MAT-SPC-en-ie-CRT- July2021.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 15 December 2020

File name

QRD-IE-SINGULAIR-10mg-LFT-IA645G-Oct 2020 (002).pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 26 May 2020

File name

QRD-IE-Singulair-10mg-Tablets-SPC-WS060 (002).pdf.pdf

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

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

Updated on 26 May 2020

File name

QRD-IE-Singulair-10mg-Tablets-PIL-WS060 (002).pdf.pdf

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

File name

SINGULAIR-FI-H-0104-WS-049-G-10mgFCT-SPC-IE-en-CRT.doc_ (002).pdf

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

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

Free text change information supplied by the pharmaceutical company

  1. 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’.
  2. Section 4.8: Addition of the following sentence: ‘obsessive-compulsive symptoms’.
  3. Section 10: ‘Date of revision of text updated to ‘December 2019’.

Updated on 15 January 2020

File name

QRD-IE-SINGULAIR-10mgFCT-EN-PIL-WS049-CRT (002).pdf

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

  1. 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’.
  2. Change to section 4 - possible side effects: Very rare: behaviour and mood related changes: obsessive-compulsive symptoms
  3. Change to section 6 – other: Authorization of medicinal product: 1 country removed
  4. Change to section 6 - date of revision: New Date of Revision

Updated on 18 June 2019

File name

SINGULAIR-FI-H-0104-001-WS-021-Tablet10mg-SPC-IE-en-CRT June 2018.pdf

Reasons for updating

  • Improved presentation of SPC

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

File name

QRD_PIL_Singulair 10mg_deletion of UK details_CRT (2).pdf

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

File name

SINGULAIR-FI-H-0104-001-WS-021-Tablet10mg-SPC-IE-en-CRT.docx

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

File name

008 PIL.SGA-10mg.16.UK.4893.WS-021 clean (2).pdf

Reasons for updating

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

Updated on 07 March 2016

File name

PIL_9220_369.pdf

Reasons for updating

  • New PIL for new product

Updated on 07 March 2016

Reasons for updating

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

Updated on 04 March 2016

Reasons for updating

  • New SPC for new product

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

Updated on 04 March 2016

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

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

Reasons for updating

  • Change to MA holder contact details

Updated on 21 October 2014

Reasons for updating

  • Change to side-effects

Updated on 21 August 2014

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 01 November 2013

Reasons for updating

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

Updated on 08 July 2013

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 07 January 2013

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 06 December 2012

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

Reasons for updating

  • Change to side-effects

Updated on 24 April 2012

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

Reasons for updating

  • Change to side-effects

Updated on 26 August 2011

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

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 01 September 2010

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

Reasons for updating

  • Change to side-effects

Updated on 13 November 2009

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

Reasons for updating

  • Change to side-effects

Updated on 27 August 2009

Reasons for updating

  • Change to side-effects

Updated on 01 December 2008

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 01 December 2008

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 03 July 2008

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 03 July 2008

Reasons for updating

  • Change to side-effects

Updated on 21 February 2008

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 09 January 2008

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

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

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

Reasons for updating

  • Change to drug interactions

Updated on 02 May 2006

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

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 02 November 2005

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

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

Reasons for updating

  • Change to drug interactions
  • Change to side-effects

Updated on 01 March 2005

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 01 March 2005

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

Reasons for updating

  • New PIL for medicines.ie

Updated on 21 January 2004

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

Reasons for updating

  • New SPC for medicines.ie

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