Nurofen for Children Strawberry 100mg/5ml Oral Suspension
*Company:
Reckitt Benckiser Ireland LimitedStatus:
No Recent UpdateLegal Category:
Supply through pharmacy onlyActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 05 June 2024
File name
NfC Strawberry 100mg_5ml PIL (May24).pdf
Reasons for updating
- New PIL for new product
Updated on 05 June 2024
File name
NfC Strawberry 100mg_5ml SmPC (May24).pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Supply through pharmacy only
Updated on 28 January 2021
File name
NFC Sberry 100mg_5ml Oral Suspension SmPC Dec20.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 28 February 2020
File name
Nurofen for Children Strawberry 100mg_5ml Oral Suspension PIL.pdf
Reasons for updating
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Addition of DRESS text
Updated on 28 February 2020
File name
Nurofen for Children Strawberry 100mg_5ml Oral Suspension - Oct19.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
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 Strawberry 100mg-5ml Oral Suspension.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 21 February 2017
File name
PIL_14465_451.pdf
Reasons for updating
- New PIL for new product
Updated on 21 February 2017
Reasons for updating
- Change to section 4 - possible side effects
Updated on 07 November 2016
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Updated on 07 November 2016
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
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to drug interactions
Updated on 22 April 2016
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
Updated on 10 October 2014
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 on 07 October 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to dosage and administration
Updated on 07 July 2014
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 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 03 July 2014
Reasons for updating
- Introduction of new pack/pack size
Updated on 20 December 2013
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
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 10, updated the date of revision of text to December 2012
Updated on 18 November 2011
Reasons for updating
- Change due to user-testing of patient information
Updated on 27 October 2009
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 27 October 2009
Reasons for updating
- New PIL for new product