Nurofen for Children Sachets 100 mg/5 ml Oral Suspension

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Ibuprofen

Beschikbaar vanaf:

Reckitt Benckiser Ireland Ltd

ATC-code:

M01AE; M01AE01

INN (Algemene Internationale Benaming):

Ibuprofen

Dosering:

100 mg/5ml

farmaceutische vorm:

Oral suspension

Prescription-type:

Product not subject to medical prescription

Therapeutisch gebied:

Propionic acid derivatives; ibuprofen

Autorisatie-status:

Not marketed

Autorisatie datum:

2010-07-22

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
NUROFEN FOR CHILDREN SACHETS
100 MG / 5 ML ORAL SUSPENSION
IBUPROFEN
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION
FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist or nurse has told you
Keep this leaflet. You may need to read it again
Ask your pharmacist if you need more information or advice
If you or your child get any side effects, talk to your doctor or
pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
You must talk to a doctor if your child does not feel better or feels
worse after 24 hours for infants aged 3 –
5 months. You must talk to a doctor if your child does not feel better
or feels worse after 3 days for
children over 6 months.
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.
WHAT IS IN THIS LEAFLET
1.
WHAT NUROFEN FOR CHILDREN IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU GIVE 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.
CONTENTS OF THE PACK AND OTHER 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 an 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.
WHAT YOU NEED TO KNOW BEFORE YOU GIVE NUROFEN FOR CHILDREN
This medicine is suitable for the majority of people but certain
people should not use it. Talk to your

Productkenmerken

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 Sachets 100 mg/5 ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen 100 mg per 5 ml sachet
Excipients with known effects:
Maltitol liquid 2226 mg per 5 ml
Sodium 9.08 mg (0.39 mmol) per 5 ml
Wheat starch 11 mg, containing no more than 0.225 µg gluten per 5 ml
For a full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Oral suspension
An off-white orange flavoured syrup-like 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, toothache, 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 Sachets 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 weighing over 5kg
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
5ml, 3 times a day
4 to 6 years
17-20
7.5ml (5ml + 2.5ml spoonful) 3 times a day
7 to 9 years
21-30
10ml (two 5ml spoonfuls) 3 times a day
10 to 12 years
31-40
15ml (three 5ml spoonfuls) 3 times a day
Do not dose more frequently than at 6 hourly intervals. The
recommended dose should not be exceeded.
Not suitable for children under 3 months of age unless advised by your
doctor.
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