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Nurofen 200mg Coated Tablets

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Pharmacy Only: Non-prescription

Updated on 10 April 2024

File name

IE PIL NUROFEN 200mg Tablets Clean CRN00DDJT PRAC 7.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility

Updated on 10 April 2024

File name

SPC Nurofen 200mg Tablets Clean CRN00DDJT PRAC 7.pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation

Legal category:Supply through pharmacy only

Updated on 23 October 2021

File name

Nurofen 200mg Tabs PIL Apr21.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 23 October 2021

File name

Nurofen 200mg Tablets SmPC Apr21.pdf

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 02 April 2020

File name

IE SPC Nurofen 200mg Tablets Mar 2020.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Supply through pharmacy only

Updated on 02 April 2020

File name

200mg Coated Tablets.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 15 January 2020

File name

Nurofen 200 mg Coated Tablets.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 16 August 2017

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 16 August 2017

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

File name

PIL_12698_910.pdf

Reasons for updating

  • New PIL for new product

Updated on 15 August 2017

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

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 07 October 2014

Reasons for updating

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

Updated on 04 March 2014

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 03 March 2014

Reasons for updating

  • Change due to harmonisation of PIL

Updated on 15 March 2012

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

Reasons for updating

  • Change due to user-testing of patient information

Updated on 13 October 2011

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

Reasons for updating

  • Change to improve clarity and readability

Updated on 21 May 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
  • 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 21 May 2009

Reasons for updating

  • Change to drug interactions

Updated on 10 December 2007

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

Reasons for updating

  • Change of inactive ingredient

Updated on 04 December 2007

Reasons for updating

  • New PIL for medicines.ie

Updated on 27 August 2007

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through pharmacy only