Nurofen 200mg Coated Tablets

  • Name:

    Nurofen 200mg Coated Tablets

  • Company:
    info
  • Active Ingredients:

    Ibuprofen

  • Legal Category:

    Supply through pharmacy only

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 15/08/17

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Summary of Product Characteristics last updated on medicines.ie: 16/8/2017
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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 16 August 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 16 August 2017 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 4.2, 4.3, 4.4, 4.5, 4.8, 5.1 - Article 31 text
Section 4.4 and 4.8- chicken Pox warning
Section 10 - revision of text update

Updated on 15 August 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 15 August 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects

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 4 March 2014 SmPC

Reasons for updating

  • Change due to harmonisation of SPC

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Change to SPC to update in line with CCDS

Updated on 3 March 2014 PIL

Reasons for updating

  • Change due to harmonisation of PIL

Updated on 15 March 2012 SmPC

Reasons for updating

  • Change to section 6.1 - List of excipients

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In Section 6.1 - included the following:

Black Printing Ink

(iron oxide black (E172), propylene glycol (E1520), shellac)

Updated on 14 March 2012 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 13 October 2011 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 2 - to include statement "

For a full list of excipients, see section 6.1.

Section 6.1 - to divide the list of excipients into tablet core and tablet coat

Updated on 12 October 2011 PIL

Reasons for updating

  • Change to improve clarity and readability

Updated on 21 May 2009 PIL

Reasons for updating

  • Change to drug interactions

Updated on 21 May 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
  • 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 4.5 new information added -

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 new information added

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 10 December 2007 SmPC

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 4.8 - Undesirable effects

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Addition of NSAID warnings to sections 4.3, 4.4, 4.5 and 4.8 of the SPC

Updated on 10 December 2007 PIL

Reasons for updating

  • Change of inactive ingredient

Updated on 4 December 2007 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 27 August 2007 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through pharmacy only