Nurofen for Children 60mg Suppositories age 3 months to 2 years

  • Name:

    Nurofen for Children 60mg Suppositories age 3 months to 2 years

  • Company:
    info
  • Active Ingredients:

    Ibuprofen

  • Legal Category:

    Supply through pharmacy only

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 21/02/17

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Summary of Product Characteristics last updated on medicines.ie: 2/2/2017
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Reckitt Benckiser Ireland Limited

Reckitt Benckiser Ireland Limited

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1 - 0 of 64 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 21 February 2017 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 21 February 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 2 February 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 2 February 2017 SmPC

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

update to section 4.4 and 4.8

Updated on 11 August 2015 SmPC

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 7 August 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to drug interactions
  • Change to warnings or special precautions for use

Updated on 10 October 2014 SmPC

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 in relation to Article 45

Updated on 7 October 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to dosage and administration

Updated on 24 March 2014 SmPC

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 2 " For the full list of excipients, see section 6.1"
Section 3 Suppostories changed to suppository

Updated on 30 November 2011 SmPC

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 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 10 June 2009 SmPC

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 PIL

Reasons for updating

  • Change to drug interactions

Updated on 18 December 2008 PIL

Reasons for updating

  • New PIL for new product

Updated on 8 October 2008 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Supply through pharmacy only