Nurofen for Children Strawberry 100mg/5ml Oral Suspension

  • Name:

    Nurofen for Children Strawberry 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: 21/02/17

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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 21 February 2017 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 21 February 2017 PIL

Reasons for updating

  • New PIL for new product

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 Strawberry 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 drug interactions

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 - how to report a side effect
  • 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 7 July 2014 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 6.5 - Nature and contents of container

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 2, excipient of known effect Maltitol liquid 1.625/5ml and sodium 1.2mmol (or 27.75mg) per dose (15ml)

In section 4.4 - sodium warning added

In section 4.5 - text in relatio nto ibuprofen inhobotin low dose aspirin agged

In section 6.5 - Gradution of 2.5ml and 5ml added

Updated on 3 July 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 200 ml of product.

 

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

 

A plastic double-ended spoon with measures of 2.5 ml and 5 ml will be provided.

OR

A 5ml oral dosage syringe, comprised of an orange PE piston and clear PP barrel. Bottles supplied with the dosing syringe have a PE insert included in the bottle neck to facilitate the use of the syringe.

 

Not all pack sizes may be marketed.

Updated on 18 January 2013 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

Free text change information supplied by the pharmaceutical company

Section 4.4, added warning regarding the level of sodium.

Section 10, updated the date of revision of text to December 2012

Updated on 18 November 2011 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 27 October 2009 PIL

Reasons for updating

  • New PIL for new product

Updated on 27 October 2009 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