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Nurofen 5% Gel

  • Name:

    Nurofen 5% Gel

  • Company:
    info
  • Active Ingredients:

    Ibuprofen

  • Legal Category:

    Supply through pharmacy only

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 31/03/15

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Summary of Product Characteristics last updated on medicines.ie: 30/3/2015
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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 31 March 2015 PIL

Reasons for updating

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

Updated on 31 March 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 30 March 2015 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 30 March 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 - 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

All sections updated in line with CCDS

Updated on 31 July 2013 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

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Updated Section 4.2 to state the following:

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 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications

Updated on 5 March 2013 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 22 November 2012 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 17 February 2012 SmPC

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

Included the following text in section 5.1:

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 PIL

Reasons for updating

  • Change to improve clarity and readability

Updated on 29 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 5 August 2009 PIL

Reasons for updating

  • Change to drug interactions

Updated on 11 June 2009 SmPC

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 SmPC

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 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 27 August 2007 SmPC

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

Change to section 7 - Marketing Authorisation Holder, Change to section 8 - MA number, Change to section 10 (date of (partial) revision of the text

Updated on 23 May 2006 SmPC

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 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Updated on 27 June 2003 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Supply through pharmacy only

Updated on 26 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through pharmacy only