Nurofen for Children Strawberry 100 mg/5 ml oral suspension

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Ibuprofen

Beszerezhető a:

Reckitt Benckiser Ireland Ltd

ATC-kód:

M01AE; M01AE01

INN (nemzetközi neve):

Ibuprofen

Adagolás:

100 mg/5ml

Gyógyszerészeti forma:

Oral suspension

Recept típusa:

Product not subject to medical prescription

Terápiás terület:

Propionic acid derivatives; ibuprofen

Engedélyezési státusz:

Marketed

Engedély dátuma:

2008-09-26

Betegtájékoztató

PACKAGE LEAFLET: INFORMATION FOR THE USER
Nurofen for Children Strawberry
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

Termékjellemzők

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 Strawberry 100 mg/5 ml oral suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen 100 mg/5 ml (equivalent to 2.0% w/v)
Excipient of known effect:
Maltitol liquid 1.625 mg/5ml.
Sodium 1.2mmol (or 27.75 mg) per dose (15ml)
For excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral Suspension
An off-white strawberry 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 Strawberry 100mg/5ml
Oral Suspension 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 10mg/kg body weight as a 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