Nurofen for Children Orange 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 Orange 100mg_5ml PIL (May24).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 05 June 2024
File name
NfC Orange 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
Legal category:Supply through pharmacy only
Updated on 28 January 2021
File name
NfC Orange 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 Orange 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 Orange 100mg_5ml Oral Supension SmPC - 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 data
Updated on 15 January 2020
File name
Nurofen for Children Orange 100mg-5ml Oral suspension.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 04 September 2017
File name
PIL_12658_925.pdf
Reasons for updating
- New PIL for new product
Updated on 04 September 2017
Reasons for updating
- Change to section 6 - manufacturer
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
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
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
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
- 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 01 September 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 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
Reasons for updating
- Change due to user-testing of patient information
Updated on 03 September 2009
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 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
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
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
Reasons for updating
- Change to drug interactions
Updated on 18 December 2008
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
Updated on 18 December 2008
Reasons for updating
- Change to dosage and administration
Updated on 19 November 2007
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
Updated on 19 November 2007
Reasons for updating
- New PIL for medicines.ie
Updated on 02 August 2007
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
Updated on 22 May 2006
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
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
Legal category:Supply through pharmacy only
Updated on 27 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through pharmacy only