Otrivine Congestion Relief Menthol, 0.1% w/v Nasal Spray, Solution
*Company:
Haleon Ireland LimitedStatus:
No Recent UpdateLegal Category:
Supply through pharmacy onlyActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
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