Otrivine Congestion Relief Menthol, 0.1% w/v Nasal Spray, Solution
*Company:
Haleon Ireland LimitedStatus:
UpdatedLegal Category:
Supply through pharmacy onlyActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 12 March 2026
File name
ie-spc-congestion relief menthol-120-5-Freepod+Khone.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 6.5 - Nature and contents of container
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Combined document of Freepod and Khone (to be launched in Q3 2026)
Updated on 12 March 2026
File name
working-ie-Freepod-pl-text-otrivine-congestion-120-5-Freepod+Khone.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Combined document of Freepod and Khone (to be launched in Q3 2026)
Updated on 30 May 2025
File name
working-ie-SPC-678-120-5-otrivine-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 30 May 2025
File name
working-ie-PIL-678-120-5-otrivine-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 12 December 2024
File name
working-ie-pl-678-120-5-otrivine-GSK Munich Deletion-clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 23 February 2024
File name
Otrivine Congestion Relief Menthol 0.1% wv Nasal Spray, Solution PA 0678-120-005.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 29 November 2023
File name
ie-working-spc-678-120-5-otrivine-GDSv3 Xyloh-230707SL-clean_HPRA comments_amended.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Addition of detailed warnings about the interactions of tri- and tetra-cyclic antidepressants, monoamine oxidase inhibitors, anti-hypertensives and Xylometazoline
Updated on 29 November 2023
File name
ie-pl-678-120-5-otrivine-spray-proposed-clean_31Oct2023_230707SL.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Free text change information supplied by the pharmaceutical company
Addition of "Other Medicines and Otrivine" detailing warnings about the interactions of tri- and tetra-cyclic antidepressants, monoamine oxidase inhibitors, high blood pressure medications and Xylometazoline
Updated on 29 June 2023
File name
ie-working-spc-678-120-5-otrivine-congestion-relief-menthol-F6-IAIN-separation_230622RE.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 29 June 2023
File name
ie-pil-mockup-005-Haleon_230622RE.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 28 October 2022
File name
ie-approved-leaflet-Congestion Relief Menthol-F6.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 14 October 2022
File name
ie-working-spc-otrivine-menthol-005-congestionrelief-newname-final-220311EM-clean.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 14 October 2022
File name
ie-working-text-leaflet-otrivin-menthol-120-5-name change-FINAL2-220311EM-clean.pdf
Reasons for updating
- Change to name of medicinal product
- Change to date of revision
Updated on 26 May 2021
File name
ie-spc-otrivine-005-mucus-relief-clean-rfi4-gds-prac-mar2021.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- 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 4.8 – Undesirable effects - how to report a side effect
Legal category:Supply through pharmacy only
Updated on 26 May 2021
File name
ie-mockup-leaflet-adultmucus-120-5-rfi4-gds-prac.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 01 December 2020
File name
ie-spc-otrivineadultmucus-120-5-renewal-APPROVED 27Nov2020.pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Legal category:Supply through pharmacy only
Updated on 08 August 2019
File name
Otrivine Mucus IE - HPRA Leaflet.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 14 February 2019
File name
PIL_16974_362.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 02 November 2016
File name
PIL_16974_362.pdf
Reasons for updating
- New PIL for new product
Updated on 04 October 2016
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Updated on 04 October 2016
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:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 15 September 2014
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Haleon Ireland Limited
Address:
12 Riverwalk, Citywest Business Campus, Dublin 24, IrelandMedical Information Direct Line:
1800 441 442