Login

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

*
Pharmacy Only: Non-prescription

  • Company:

    Reckitt Benckiser Ireland Limited

  • Status:

    No Recent Update

  • Legal Category:

    Supply through pharmacy only

  • Active Ingredient(s):

    Ibuprofen

    *Additional information is available within the SPC or upon request to the company

Updated on 15 October 2021

File name

NFC Six Plus Strawberry SmPC Aug21.pdf

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

Updated on 15 October 2021

File name

NfC Six Plus Strawberry PIL.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 03 April 2020

File name

Nurofen for Children Six Plus Strawberry PIL Oct19.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 28 February 2020

File name

Nurofen for Children Six Plus Strawberry SmPC Oct19.pdf

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

Addition of DRESS text

Updated on 15 January 2020

File name

Nurofen for Children Six Plus Strawberry 200mg-5ml Oral Suspension.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 21 October 2019

File name

Nurofen for Children Six Plus Strawberry 200mg_5ml Oral Suspension SmPC Mar18.pdf

Reasons for updating

  • Improved presentation of SPC

Legal category:Supply through pharmacy only

Updated on 05 June 2018

File name

Nurofen for Children Six Plus Strawberry 200mg_5ml Oral Suspension SmPC Mar18.docx

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 cererovascular 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 07 March 2016

File name

PIL_14990_659.pdf

Reasons for updating

  • New PIL for new product

Updated on 07 March 2016

Reasons for updating

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

Updated on 04 March 2016

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 04 March 2016

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

CCDS update

Updated on 19 August 2014

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 05 August 2014

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

addition of ADR reporting

Updated on 06 February 2014

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 pack size 200ml

Updated on 29 January 2014

Reasons for updating

  • Introduction of new pack/pack size

Updated on 12 June 2012

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

Dosage table in section 4.2 has been revised and now states the following:

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

Updated on 10 April 2012

Reasons for updating

  • Change to dosage and administration

Updated on 17 May 2011

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

Updated on 16 May 2011

Reasons for updating

  • New PIL for new product