Nurofen for Children Orange 100 mg/5 ml oral suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ibuprofen

Available from:

Reckitt Benckiser Ireland Ltd

ATC code:

M01AE; M01AE01

INN (International Name):

Ibuprofen

Dosage:

100 mg/5ml

Pharmaceutical form:

Oral suspension

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Propionic acid derivatives; ibuprofen

Authorization status:

Marketed

Authorization date:

1998-12-21

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Nurofen for Children Orange
100mg/5ml Oral Suspension
ibuprofen
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU USE THIS MEDICINE. IT
CONTAINS IMPORTANT INFORMATION.
KEEP THIS LEAFLET: YOU MIGHT NEED IT AGAIN
If you have any further questions after you have read it ask your
doctor or pharmacist.
This medicine is designed to help bring down a high temperature and
relieves pain from headaches,
earache, sore throats, minor aches and sprains, cold and flu symptoms,
teething and toothache
This medicine is suitable for most babies over 3 months of age,
children and adults
Follow the dosage instructions carefully. Section 3 shows the
difference amounts that children need
SPEAK TO YOUR DOCTOR IF YOUR CHILD:
Suffers from any of the conditions listed in Section 2 of the leaflet
Is taking other medicines. See section 2
Is not getting better, or you feel at all concerned. See section 3
Develops a rash, breathing problems or diarrhoea and gets very tired.
See Section 3
Do not use this medicine and speak to your doctor if you are pregnant,
think you may be pregnant or trying
to get pregnant or are breast-feeding. See Section 2.
IN THIS LEAFLET:
1.
What Nurofen for Children is and what it is used for
2.
Before giving Nurofen for Children to your child
3.
How to use Nurofen for Children
4.
Possible side-effects
5.
How to store Nurofen for Children
6.
Further information
1.
WHAT NUROFEN FOR CHILDREN IS AND WHAT IT IS USED FOR?
The active ingredient (which makes this medicine work) is ibuprofen
which is a non-steroidal anti-
inflammatory (NSAID) painkiller. Ibuprofen is used as an analgesic
(painkiller) for the relief of teething and
toothache pain, earache, headache, muscular minor aches and sprains,
sore throats and cold and flu
symptoms. Nurofen for Children also reduces a high temperature
(fever).
2.
BEFORE GIVING NUROFEN FOR CHILDREN TO YOUR CHILD
This medicine is suitable for the majority of people, but certain
people should not use it. Talk to your
pharmacist or doctor if you are at a

Summary of Product characteristics

Health Products Regulatory Authority
13 January 2023
CRN00D5XN
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nurofen for Children Orange 100 mg/5 ml oral suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen 100 mg/5 ml (equivalent to 2.0% w/v)
Also contains maltitol syrup 1.6ml/5ml
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension.
An off-white orange flavoured syrupy suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Reduction of fever and relief of mild to moderate pain, such as cold
and flu symptoms, teething pain, headache, sprains and
strains and to ease the pain of sore throats and earache.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
For short term use only.
The maximum daily dosage of Nurofen For Children is 30 mg of
ibuprofen/kg bodyweight administered in divided doses. The
symptomatic treatment of mild to moderate pain, and/or fever in
children and adolescents depends on body weight and age
respectively – in general with 7 to 10 mg/kg body weight as single
dosage.
This can be achieved as follows:
Age and/or bodyweight can be used as a guide to select the correct
dose.
AGE
BODY WEIGHT (KG)
RECOMMENDED DOSAGE
3 to 6 months
5-7.6
2.5ml, 3 times a day
6 to 12 months
7.7-9
2.5ml, 3 times a day
1 to 3 years
10-16
5 ml, 3 times a day
4 to 6 years
17-20
7.5 ml, 3 times a day
7 to 9 years
21-30
10 ml, (two 5ml spoonfuls) 3 times a day
10 to 12 years
31-40
15 ml, (three 5ml spoonfuls) 3 times a day
This product should only be given to infants aged 3-6 months who weigh
more than 5kg. For infants aged 3-5 months medical
advice should be sought if symptoms worsen or not later than 24 hours
if symptoms persist. If in children aged from 6 months
and in adolescents this medicinal product is required for more than 3
days, or if symptoms worsen a doctor should be
consulted.
Do not dose more frequently than at 6 hourly intervals. The
recommended dose should not be exceeded.
The lowest effective dose should be used for the s