Nurofen for Children Six Plus Orange 200mg/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 16 September 2024
File name
NfC 6+ Orange PIL Aug23.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 16 September 2024
File name
NfC 6+ Orange PIL Aug23.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 16 September 2024
File name
NFC Six Plus Orange SmPC Aug23.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
Legal category:Supply through pharmacy only
Updated on 16 September 2024
File name
NfC 6+ Orange PIL Aug23.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
Updated on 15 October 2021
File name
NfC Six Plus Orange 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 15 October 2021
File name
NfC Six Plus Orange 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 28 February 2020
File name
Nurofen for Children Six Plus Orange PIL Oct19.pdf
Reasons for updating
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Addition od DRESS text
Updated on 28 February 2020
File name
Nurofen for Children Six Plus Orange 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 28 February 2020
File name
Nurofen for Children Six Plus Orange 200mg_5ml Oral Supsension 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 15 January 2020
File name
Nurofen for Children Six Plus Orange 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 Orange 200mg_5ml Oral Suspension SPC 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 Orange 200mg_5ml Oral Suspension SPC 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 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 07 March 2016
File name
PIL_14989_385.pdf
Reasons for updating
- New PIL for new product
Updated on 07 March 2016
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to information about pregnancy or lactation
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
Updated on 21 August 2014
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 31 July 2014
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
Updated on 04 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
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 now states the following:
4.2 Posology and method of administration
|
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
Reasons for updating
- Change to dosage and administration
Updated on 16 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
Updated on 16 May 2011
Reasons for updating
- New PIL for new product