Nurofen for Children 60mg Suppositories age 3 months to 2 years
*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 05 May 2021
File name
NFC Suppositories PIL (Dec20).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 28 January 2021
File name
NfC 60mg Suppositories SmPC Dec20.
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 28 February 2020
File name
Nurofen for Children 60mg Suppositories PIL.pdf
Reasons for updating
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Addition of DRESS text
Updated on 28 February 2020
File name
Nurofen for Children 60mg Suppositories SmPC - Oct19.pdf
Reasons for updating
- 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
Addition of DRESS text
Updated on 21 February 2017
File name
PIL_13955_817.pdf
Reasons for updating
- New PIL for new product
Updated on 21 February 2017
Reasons for updating
- Change to section 4 - possible side effects
Updated on 02 February 2017
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Updated on 02 February 2017
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 11 August 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
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Sections updated in line with CCDS
Updated on 07 August 2015
Reasons for updating
- Change to side-effects
- Change to drug interactions
- Change to warnings or special precautions for use
Updated on 10 October 2014
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 07 October 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to dosage and administration
Updated on 24 March 2014
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Section 3 Suppostories changed to suppository
Updated on 30 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 23 November 2011
Reasons for updating
- Change due to user-testing of patient information
Updated on 10 June 2009
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- 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
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 May 2009
Reasons for updating
- Change to drug interactions
Updated on 18 December 2008
Reasons for updating
- New PIL for new product
Updated on 08 October 2008
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only