Nurofen for Children Orange 100mg/5ml Oral Suspension

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Ibuprofen

Disponible desde:

Imbat Limited

Código ATC:

M01AE; M01AE01

Designación común internacional (DCI):

Ibuprofen

Dosis:

100 mg/5ml

formulario farmacéutico:

Oral suspension

tipo de receta:

Product not subject to medical prescription

Área terapéutica:

Propionic acid derivatives; ibuprofen

Estado de Autorización:

Authorised

Fecha de autorización:

2013-10-11

Información para el usuario

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
NUROFEN
® FOR CHILDREN ORANGE
100MG/5ML ORAL SUSPENSION (ibuprofen)
Your medicine is available using the above name but will be referred
to as Nurofen for Children
throughout this leaflet.
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
different 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.
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 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 tempera

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nurofen for Children Orange 100mg/5ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of suspension contains 100 mg Ibuprofen (equivalent to 2%
w/v).
Also contains maltitol syrup and sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension.
_Product imported from Spain:_
An off-white orange flavoured syrupy suspension.
4 CLINICAL PARTICULARS
As per PA0979/032/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0979/032/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Maltitol syrup
Citric acid
Sodium citrate
Sodium chloride
Sodium saccharin
Domiphen bromide
Polysorbate 80
Xanthan gum
Orange flavour
Glycerol (E422)
Purified water
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6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the blister strips and outer carton of the product as
marketed in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage
conditions.
6.5 NATURE AND CONTENTS OF CONTAINER
Amber-coloured 150 ml bottle with a 5 ml oral dosing syringe in an
cardboard outer carton.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM
SUCH MEDICIN