Nurofen 5% Gel
*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 16 February 2023
File name
Nurofen 5% Gel PIL.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Updated on 16 February 2023
File name
Nurofen 5% Gel SPC.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Supply through pharmacy only
Updated on 26 May 2020
File name
PIL RBL1913083 (2).pdf
Reasons for updating
- New PIL for medicines.ie
Updated on 15 January 2020
File name
Nurofen 5% Gel.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 31 March 2015
File name
PIL_12593_733.pdf
Reasons for updating
- New PIL for new product
Updated on 31 March 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to dosage and administration
- Change to name of manufacturer
Updated on 30 March 2015
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Updated on 30 March 2015
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 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 31 July 2013
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
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Adults, the elderly and children over 12 years: Unscrew and invert cap to pierce seal. Apply a thin layer of gel from the tube to the affected area and massage gently until absorbed. Repeat as necessary up to three times a day.
Wash hands after each application. Do not exceed the stated dose.
The product should be applied according to the pack instructions for up to a maximum of 7 days. Seek medical advice if symptoms persist for more than one week.
Children under 12 years: Do not use on children under 12 years of age except on the advice of a doctor.
Updated Section 4.3 to include:
Children under 12 years
Updated section 4.4 to include:
Not recommended for children under 12 years.
Patients should be advised against excessive exposure to sunlight of area treated in order to avoid possibility of photosensitivity.
Updated section 4.4 to include:Updated on 25 July 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
Updated on 05 March 2013
Reasons for updating
- Correction of spelling/typing errors
Updated on 22 November 2012
Reasons for updating
- Change due to user-testing of patient information
Updated on 17 February 2012
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
5.1 Pharmacodynamic Properties
Pharmacotherapeutic group: Anit-inflammatory preparations, non-steroids for topical use.
ATC code: M02A A13
Deleted Hyetellose from section 6.1
Updated on 16 February 2012
Reasons for updating
- Change to improve clarity and readability
Updated on 29 November 2011
Reasons for updating
- 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
Section 10 - change in the revision date
Updated on 05 August 2009
Reasons for updating
- Change to drug interactions
Updated on 11 June 2009
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Section 4.5 - Addition of following information -
Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelets aggregation when they are dosed concomitantly. However, the limitations of these data and the uncertainties regarding the extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional use (see section 5.1)
Section 5.1 - addition of the following text -
Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelets aggregation when they are dosed concomitantly. In one study, when a single dose of ibuprofen 400mg was taken within 8 h before or within 30 min after immediate release aspirin (81mg), a decreased effect of ASA on the formation of thromboxane or platelet aggregation occurred. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use.
Updated on 22 August 2008
Reasons for updating
- Change to section 8 - MA number
- Change to section 7 - Marketing authorisation holder
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Change MA holder from Crookes Healthacre to Reckitt Benckiser Ireland
Updated on 10 December 2007
Reasons for updating
- New PIL for medicines.ie
Updated on 27 August 2007
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
- Change to section 8 - MA number
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 23 May 2006
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 3 - Pharmaceutical form
Legal category:Supply through pharmacy only
Updated on 20 August 2003
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 27 June 2003
Reasons for updating
- Correction of spelling/typing errors
Legal category:Supply through pharmacy only
Updated on 26 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through pharmacy only