Singulair Paediatric 4mg Oral Granules
*Company:
Organon Pharma (Ireland) LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 05 July 2023
File name
QRD-IE-Singulair Paediatric-4mg-Granules-PIL-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 4MGPG-FI-H-0104-WS-112-SPC-IE_en-CRT.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 31 January 2023
File name
Singulair 4mg paediatric granules -FI-H-0104-WS-086-MAT SPC-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 4mg paediatric granules -FI-H-0104-WS-086-MAT SPC-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 Paediatric-4mg-Granules-PIL-WS MAT CRT.pdf
Reasons for updating
- Change to section 6 - marketing authorisation number
Updated on 07 September 2021
File name
SINGULAIR 4mg Granules-FI-H-0104-MAT-SPC-en-ie-CRT- July 2021.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 26 May 2020
File name
QRD-IE-Singulair Paediatric-4mg-Granules-WS060-SPC (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 Paediatric-4mg-Granules-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
QRD-IE-SINGULAIR-4mgGranules-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
- 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 15 January 2020
File name
SINGULAIR-4mgGranules-EN-SPC-WS049-CRT (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
- 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 18 June 2019
File name
SINGULAIR-FI-H-0104-004-WS-021-Granules4mg-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 4mgOG_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-0104-004-WS-021-Granules4mg-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-OG.16.UK.4899.WS-021 clean (2).pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 04 October 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 04 October 2016
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 6.1 - List of excipients
- 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 03 October 2016
File name
PIL_9221_480.pdf
Reasons for updating
- New PIL for new product
Updated on 03 October 2016
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 14 March 2016
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
SPC change details: The SPC has been revised to reflect the change in MAH name, MAH address and MA number
Updated on 14 March 2016
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder
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
- 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 01 April 2015
Reasons for updating
- Change to section 6.4 - Special precautions for storage
- 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 6.4 and section 10
Section 6.4 – following sentence has been added at the beginning of the section “Do not store above 25°C.”
Section 10 – last revision date change to March 2015
Updated on 31 March 2015
Reasons for updating
- Change to storage instructions
Updated on 13 November 2014
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
- 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 9 – date of last renewal is changed to 25 August 2012
Section 10 – last revision date change to October 2014
Updated on 21 October 2014
Reasons for updating
- Change to side-effects
Updated on 21 August 2014
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
- Change to section 4.2 - Posology and method of administration
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
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 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
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 17 November 2010
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
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 27 August 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 on 21 July 2010
Reasons for updating
- Change to side-effects
Updated on 17 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)
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 29 October 2008
Reasons for 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
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
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 19 September 2008
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The change is to section 6.3. reducing the shelf-life from 3 to 2 years.
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
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 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 01 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
Updated on 24 July 2006
Reasons for updating
- Change to section 6.3 - Shelf life
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
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 10 July 2006
Reasons for updating
- Change to drug interactions
Updated on 02 May 2006
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 02 May 2006
Reasons for updating
- Change to, or new use for medicine
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 16 November 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 09 August 2004
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 28 July 2004
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)