Nurofen Sinus & Pain Film Coated Tablets
*Company:
Reckitt Benckiser 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 26 September 2024
File name
IE PIL Nurofen S&P Tabs PRAC 10 CRN00F0DT and PRAC 11 CRN00F8F5 Jul 2024.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 26 September 2024
File name
IE Nurofen Sinus and Pain SmPC CRN00F8F5 PRAC 11 and CRN00F0DT App July 2024 PRAC 10.pdf
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Supply through pharmacy only
Updated on 23 October 2021
File name
Nurofen Sinus and Pain Tabs SmPC Apr21.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Supply through pharmacy only
Updated on 23 October 2021
File name
Nurofen Sinus and Pain Tabs PIL Apr21.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 09 February 2021
File name
SPC Nurofen Sinus and Pain.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Supply through pharmacy only
Updated on 09 February 2021
File name
Sinus and Pain PIL.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 15 January 2020
File name
Nurofen Sinus & Pain Film Coated Tablets.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 03 October 2017
File name
PIL_16084_383.pdf
Reasons for updating
- New PIL for new product
Updated on 03 October 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 07 November 2016
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Updated on 07 November 2016
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Addition to Section 4.4:
Exceptionally, varicella can be at the origin of serious cutaneous and soft tissue infections complications. To date, the contributing role of NSAIDs in the worsening of these infections can not be ruled out. Thus, it is advisable to avoid use of Nurofen Sinus and Pain in case of varicella.
Addition to Section 4.8:
SYSTEM ORGAN CLASS: Infections and Infestations
FREQUENCY : Very rare
ADVERSE EVENT : Exacerbation of infections related inflammation (e.g. development of necrotising fasciitis), in exceptional cases, severe skin infections and soft tissue complications may occur during a varicella infection
Exceptionally, varicella can be at the origin of serious cutaneous and soft tissue infections complications. To date, the contributing role of NSAIDs in the worsening of these infections can not be ruled out. Thus, it is advisable to avoid use of Nurofen Sinus and Pain in case of varicella.
Addition to Section 4.8:
SYSTEM ORGAN CLASS: Infections and Infestations
FREQUENCY : Very rare
ADVERSE EVENT : Exacerbation of infections related inflammation (e.g. development of necrotising fasciitis), in exceptional cases, severe skin infections and soft tissue complications may occur during a varicella infection
Updated on 07 June 2016
Reasons for updating
- 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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
CCDS update sections highlighed updated
Updated on 11 March 2016
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
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Article 31 (ibuprofen) update
Updated on 10 March 2016
Reasons for updating
- Change to side-effects
- Change to drug interactions
- Change of special precautions for disposal
Updated on 08 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
None provided
Updated on 01 September 2014
Reasons for updating
- New PIL for new product