Nurofen Sinus & Pain Film Coated Tablets *
Pharmacy Only: Non-prescription

Updated on 23 October 2021

File name

Nurofen Sinus and Pain Tabs SmPC Apr21_1634995079.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_1634995058.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_1612887870.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_1612887760.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 15 January 2020

File name

Nurofen Sinus & Pain Film Coated Tablets_1579102422.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

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