Nurofen for Children Orange 100mg/5ml Oral suspension

  • Name:

    Nurofen for Children Orange 100mg/5ml Oral suspension

  • Company:
    info
  • Active Ingredients:

    Ibuprofen

  • Legal Category:

    Supply through pharmacy only

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 04/09/17

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Summary of Product Characteristics last updated on medicines.ie: 7/11/2016
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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 4 September 2017 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 4 September 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 21 February 2017 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 7 November 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 7 November 2016 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 to Section 4.4:
Exceptionally, varicella can be at the origin of serious cutaneous and soft tissue infections complications. To date, the contributing role of NSAIDs in the worsening of these infections can not be ruled out. Thus, it is advisable to avoid use of Nurofen for Children Orange 100mg/5ml Oral Suspension in case of varicella.


Addition to Section 4.8:
SYSTEM ORGAN CLASS: Infections and Infestations
FREQUENCY : Very rare
ADVERSE EVENT : Exacerbation of infections related inflammation (e.g. development of necrotising fasciitis), in exceptional cases, severe skin infections and soft tissue complications may occur during a varicella infection.

Updated on 29 April 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects

Updated on 22 April 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 4.6 - Pregnancy and lactation
  • 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

SPC updated in line with CCDS

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 1 September 2014 PIL

Reasons for updating

  • Introduction of new pack/pack size

Updated on 20 December 2013 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

6.5 Nature and Contents of Containers

 

Amber-coloured polyethylene terephthalate (PET) bottle with a child-resistant polypropylene or polyethylene closure fitted with a low density polyethylene liner.  The bottle contains 50 ml, 100 ml , 150 ml or 200ml of product.

 

Amber-coloured 30ml glass bottle with a child-resistant polypropylene closure fitted with a low density polyethylene liner.

 

The product is supplied with one of the following dosing devices:

 

·        A double-ended spoon, with a 2.5 ml bowl at one end and a 5 ml bowl at the other end

 

OR

 

·        A 5ml dosing syringe, comprising of an orange PE piston and a clear PP barrel

 

Not all pack sizes may be marketed.

Updated on 18 November 2011 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 3 September 2009 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
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • 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

Section 1 - "Orange" has been included in product name.

Section 4.2 - Clarification of dosage in children ages 3- 6 months and those weighing less than 5kg. Also clarification of frequency of dosage.

Section 4.3 - 4.9 and Section 5 of the SPC have been updated in line with the SPC for Nurofen for Children 60mg suppositories age 3 months -2 years PA 979/32/7

Updated on 25 August 2009 PIL

Reasons for updating

  • Change to date of revision
  • Change of trade or active ingredient name
  • Change to dosage and administration

Updated on 25 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 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 18 June 2009 PIL

Reasons for updating

  • Change to drug interactions

Updated on 18 December 2008 PIL

Reasons for updating

  • Change to dosage and administration

Updated on 18 December 2008 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

6.5: addition of a dosing syringe as an administration device

Updated on 19 November 2007 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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

IMB Class Wording - Addition of NSAID warnings

Updated on 19 November 2007 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 2 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 PA from Crookes Healthcare to Reckitt Benckiser Ireland Ltd

Updated on 22 May 2006 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • 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

Updated on 20 August 2003 SmPC

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation

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