Nurofen Plus

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 22/08/18

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Summary of Product Characteristics last updated on medicines.ie: 23/3/2018
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Reckitt Benckiser Ireland Limited

Reckitt Benckiser Ireland Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Bonjela Oromucosal Gel Active Ingredients Cetalkonium Chloride, Choline Salicylate
Medicine Name Bonjela Teething Gel Oromucosal Gel Active Ingredients Cetalkonium Chloride, Choline Salicylate
Medicine Name Dettol Antiseptic Disinfectant 4.8 % w/v Concentrate for Cutaneous Solution Active Ingredients Chloroxylenol
Medicine Name Disprin Direct 300mg Orodispersible Tablets Active Ingredients Aspirin
Medicine Name Disprin Extra Strength 500mg Effervescent Tablets Active Ingredients Acetylsalicylic Acid
Medicine Name Disprin Original 300mg Dispersible Tablets Active Ingredients Acetylsalicylic acid (Aspirin)
Medicine Name E45 Cream Active Ingredients Anhydrous Lanolin, Light Liquid Paraffin, White Soft Paraffin
Medicine Name Fybogel Citrus Active Ingredients Ispaghula Husk
Medicine Name Fybogel Mebeverine Active Ingredients Ispaghula Husk, Mebeverine Hydochloride
Medicine Name Fybogel Orange 3.5g Granules Active Ingredients Ispaghula Husk
Medicine Name Gaviscon Advance Oral Suspension Active Ingredients Potassium hydrogen carbonate, Sodium Alginate
Medicine Name Gaviscon Advance Tablets Active Ingredients Potassium Bicarbonate, Sodium Alginate
Medicine Name Gaviscon Extra Chewable Tablets Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate
Medicine Name Gaviscon Extra Oral Suspension Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate
Medicine Name Gaviscon Extra Oral Suspension 300ml Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate
Medicine Name Gaviscon Infant Active Ingredients Magnesium Alginate, Sodium Alginate
Medicine Name Gaviscon Liquid - Peppermint Flavour Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate
Medicine Name Gaviscon Liquid Aniseed Flavour Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate
Medicine Name Gaviscon Peppermint Chewable Tablets Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Hydrogen Carbonate
Medicine Name Gaviscon Suspension Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate
Medicine Name Hc45 Hydrocortisone Acetate 1% w/w Cream Active Ingredients Hydrocortisone Acetate
Medicine Name Lemsip Chesty Cough 50 mg/5 ml Oral Solution Active Ingredients Guaifenesin
Medicine Name Lemsip Cold & Flu Capsules with Caffeine Active Ingredients Caffeine, Paracetamol
Medicine Name Lemsip Cold & Flu Headcold 500mg Powder for Oral Solution Active Ingredients Paracetamol
Medicine Name Lemsip Cold & Flu Hot Lemon 500mg Powder for Oral Solution Active Ingredients Paracetamol
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 22 August 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 23 March 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 23 March 2018 SmPC

Reasons for updating

  • 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

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.4 - asthma, decreased respiratory reserve, acute respiratory depression, obstructive airways disease, prostatic hyperplasia, head injuries, conditions on which intracranial pressure is raised, paralytic ileus and in acute alcoholism added.
Section 4.5- CYP2D6 inhibitors, other opioids and Abiraterone added/.

Updated on 13 July 2017 SmPC

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

Free text change information supplied by the pharmaceutical company

Addition of chicken pox warning

Updated on 13 July 2017 SmPC

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

Free text change information supplied by the pharmaceutical company

Chicken Pox Warning

Updated on 12 July 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 12 July 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 6 - date of revision

Updated on 15 March 2016 PIL

Reasons for updating

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

Updated on 15 March 2016 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

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Article 31 (ibuprofen) update

Updated on 8 October 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to information about pregnancy or lactation

Updated on 7 October 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 4.7 - 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

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

CCDS update

Updated on 18 September 2015 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable effects

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 8 September 2014 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

PRAC recommendations included

Updated on 4 March 2014 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Change to dosage and administration

Updated on 3 March 2014 SmPC

Reasons for 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

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 September 2011 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation

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 16 September 2011 PIL

Reasons for updating

  • Change to side-effects
  • Change to information about pregnancy or lactation

Updated on 17 January 2011 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

General amendments of typographical errors

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 May 2009 PIL

Reasons for updating

  • Change to drug interactions

Updated on 22 August 2008 SmPC

Reasons for 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

Legal category: Supply 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 15 July 2008 PIL

Reasons for updating

  • Change to warnings or special precautions for 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 27 August 2007 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • 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

Transfer of MA to Reckitt Benckiser Ireland Ltd. and channge of PA number

Updated on 23 May 2006 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Supply through pharmacy only

Updated on 17 September 2004 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Updated on 16 September 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 22 September 2003 SmPC

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation

Legal category: Supply through pharmacy only

Updated on 26 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

  • New SPC for medicines.ie

Legal category: Supply through pharmacy only