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Nurofen for Children Six Plus Orange 200mg/5ml Oral Suspension

  • Name:

    Nurofen for Children Six Plus Orange 200mg/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: 07/03/16

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Summary of Product Characteristics last updated on medicines.ie: 21/10/2019

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Reckitt Benckiser Ireland Limited

Reckitt Benckiser Ireland Limited

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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 21 October 2019 SmPC

Reasons for updating

  • Improved presentation of SmPC

Legal category: Supply through pharmacy only

Updated on 5 June 2018 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 5.1 - Pharmacodynamic properties

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.2:  Amendment of text regarding dosing spoon

Section 4.3:  Addition of "in patients with severe heart failure (NYHA IV)

Section 4.4:  Addition of text in relation to cardiovascular and cerebrovascular effects

Section 4.5:  Addition of data in relation to Acetylsalicylic acid

Section 5.1: Addition of text in relation to pharmacodynamic studies

Updated on 7 March 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 7 March 2016 PIL

Reasons for updating

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

Updated on 4 March 2016 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Updated in line with CCDS

Updated on 4 March 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 21 August 2014 PIL

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 31 July 2014 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 4.8 - adverse reporting text added

Updated on 4 February 2014 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

Addition of 200ml pack size

Updated on 29 January 2014 PIL

Reasons for updating

  • Introduction of new pack/pack size

Updated on 12 June 2012 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Updated the dosage table section 4.2 to clarify posology.

Dosage table in Section 4.2 now states the following:

4.2                   Posology and method of administration

For pain and fever: The daily dosage of Nurofen For Children is 20-30 mg/kg bodyweight in divided doses. Using the measuring device provided this can be achieved as follows:

 

 

 

Child’s age (Weight)

Quantity and method of administration

Frequency

(in a 24 hour period)

6-9 years (20-30kg)

1 x 200mg/5ml

(one 5ml spoonful (large end))

3 times

9-12 years (30-40kg)

1 x 300mg/7.5ml

(one 5ml spoonful (large end) and one 2.5ml spoonful (small end))

3 times

 

 

Doses should be given approximately every 6 to 8 hours.

 

For patients with sensitive stomachs it is recommended that Nurofen for Children is taken during a meal

 

 

Not  intended for children under 6 years of age or under 20kg.

 

For oral use.

Updated on 10 April 2012 PIL

Reasons for updating

  • Change to dosage and administration

Updated on 16 May 2011 PIL

Reasons for updating

  • New PIL for new product

Updated on 16 May 2011 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

None provided