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Reckitt Benckiser Ireland Limited

7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 1 468 9200
Fax: +353 1 468 9299
Summary of Product Characteristics last updated on medicines.ie: 13/07/2017
SPC Nurofen Plus

When a pharmaceutical company changes an SPC or PIL, 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 13/07/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   11-Jul-2016
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company

Chicken Pox Warning
Updated on 13/07/2017 and displayed until 13/07/2017
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   11-Jul-2016
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company

Addition of chicken pox warning
Updated on 15/03/2016 and displayed until 13/07/2017
Reasons for adding or 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
Date of revision of text on the SPC:   29-Feb-2016
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company

Article 31 (ibuprofen) update
Updated on 07/10/2015 and displayed until 15/03/2016
Reasons for adding or 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 4.7 - Effects on ability to drive and use machines
  • 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
Date of revision of text on the SPC:   28-Sep-2015
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company

CCDS update
Updated on 18/09/2015 and displayed until 07/10/2015
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   14-Sep-2015
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company

4.2 and 4.3- updated with Article 31 text (codeine)
4.8- updated with adverse event reporting
Updated on 08/09/2014 and displayed until 18/09/2015
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
Date of revision of text on the SPC:   30-Nov-2013
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company

PRAC recommendations included
Updated on 03/03/2014 and displayed until 08/09/2014
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • 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 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   28-Nov-2013
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company



Section 4.1 - Added:

This product is indicated in patients older than 12 years of age for the treatment of acute moderate pain which is not considered to be relieved by other analgesics such as paracetamol or ibuprofen alone.

 
Section 4.2 - updated posology and risk to opioid toxcity

Section 4.3- Added:

In all paediatric patients (0-18 years of age) who undergo tonsillectomy and/or adenoidectomy for obstructive sleep apnoea syndrome due to an increased risk of developing serious and life-threatening adverse reactions (see section 4.4).

 

In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers.



Section 4.4 - Added:

CYP2D6 metabolism: Codeine is metabolised by the liver enzyme CYP2D6 into morphine, its active metabolite. If a patient has a deficiency or is completely lacking this enzyme an adequate analgesic effect will not be obtained. Estimates indicate that up to 7% of the Caucasian population may have this deficiency. However, if the patient is an extensive or ultra-rapid metaboliser there is an increased risk of developing side effects of opioid toxicity even at commonly prescribed doses. These patients convert codeine into morphine rapidly resulting in higher than expected serum morphine levels.

General symptoms of opioid toxicity include confusion, somnolence, shallow breathing, small pupils, nausea, vomiting, constipation, and lack of appetite. In severe cases this may include symptoms of circulatory and respiratory depression, which may be life-threatening and very rarely fatal. Estimates of prevalence of ultra-rapid metabolisers in different populations are summarized below:

Population                                                     

Prevalence %

African/Ethiopian                                                

29%

African American                                         

3.4% to 6.5%

Asian                                                           

1.2% to 2%

Caucasian                                                   

3.6% to 6.5%

Greek                                                                 

6.0%

Hungarian                                                          

1.9%

Northern European                                           

1 to 2%

 

Post-operative use in children: There have been reports in the published literature that codeine given post-operatively in children after tonsillectomy and/or adenoidectomy for obstructive sleep apnoea, led to rare, but life-threatening adverse events including death (see also section 4.3). All children received doses of codeine that were within the appropriate dose range; however there was evidence that these children were either ultra-rapid or extensive metabolisers in their ability to metabolise codeine to morphine.

 

Children with compromised respiratory function: Codeine is not recommended for use in children in whom respiratory function might be compromised including neuromuscular disorders, severe cardiac or respiratory conditions, upper respiratory or lung infections, multiple trauma or extensive surgical procedures. These factors may worsen symptoms of morphine toxicity.

 


Section 4.6 -

added: This product should not be used during breastfeeding (see section 4.3).

At normal therapeutic doses codeine and its active metabolite may be present in breast milk at very low doses and is unlikely to adversely affect the breast fed infant. However, if the patient is an ultra-rapid metaboliser of CYP2D6, higher levels of the active metabolite, morphine, may be present in breast milk and on very rare occasions may result in symptoms of opioid toxicity in the infant, which may be fatal.

Section 5.1 - added

Codeine is a centrally acting weak analgesic. Codeine exerts its effect through μ opioid receptors, although codeine has low affinity for these receptors, and its analgesic effect is due to its conversion to morphine. Codeine, particularly in combination with other analgesics such as paracetamol, has been shown to be effective in acute nociceptive pain.

Section 10 - Updated revision of the text to November 2013

Section 4.4 - Added: Section 4.6 -
Updated on 26/09/2011 and displayed until 03/03/2014
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
Date of revision of text on the SPC:   25-Aug-2011
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company



Section 4.4 - inclusion of:
Codeine is partially metabolised by CYP2D6.  if a patient has a deficiency or is completely lacking this enzyme they will not obtain adequate analgesic effects.  Estimated indicate that up to 7% of the caucasian population may have this deficiency.  However, if the patient is an ultra rapid metaboliser there is an increased risk of developing side effects of opioid toxicity even at low doses.  General symptoms of opioid toxicity include nausea, vomiting, constipation, lack of appetite and somnolence.  In severe cases this may include symptoms of circulatory and respiratory depression.  Estimates indicate that up to 1 to 2% of the caucasian may be ultra metabolisers.

Section 4.6 - inclusion of 

At normal therapeutic doses codeine and its active metabolites may be present in breast milk at very low doses and are unlikely to adversely affect the breast fed infant.

 

However, if the patient is an ultra-rapid metaboliser of CYP2D6, higher levels of the active metabolites may be present in breast milk and on very rare occasions may result in symptoms of opioid toxicity in the infant.

 

If symptoms of opioid toxicity develop in either the mother or the infant, then all codeine containing medicines should be stopped and alternative non-opioid analgesics prescribed.  In severe cases consideration should be given to prescribing naloxone to reverse these effects.

Updated on 17/01/2011 and displayed until 26/09/2011
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   01-Apr-2009
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company

General amendments of typographical errors
Updated on 11/06/2009 and displayed until 17/01/2011
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   20-Oct-2008
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 22/08/2008 and displayed until 11/06/2009
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   02/2008
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company

Changes to all sections requested by the IMB during license renewal
Updated on 10/12/2007 and displayed until 22/08/2008
Reasons for adding or 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
Date of revision of text on the SPC:   08/2007
Legal Category:   retail sale 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 27/08/2007 and displayed until 10/12/2007
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01/2007
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company

Transfer of MA to Reckitt Benckiser Ireland Ltd. and channge of PA number
Updated on 23/05/2006 and displayed until 27/08/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
Updated on 17/09/2004 and displayed until 23/05/2006
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
Updated on 22/09/2003 and displayed until 17/09/2004
Reasons for adding or updating:
  • Change to section 9 - Date of renewal of authorisation
Updated on 26/08/2003 and displayed until 22/09/2003
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Updated on 27/06/2003 and displayed until 26/08/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Ibuprofen
   Codeine Phosphate Hemihydrate