Nurofen for Children Orange 100 mg/5 ml oral suspension

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Ibuprofen

Disponible desde:

PCO Manufacturing Ltd.

Código ATC:

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:

ibuprofen

Estado de Autorización:

Authorised

Fecha de autorización:

2014-08-15

Información para el usuario

_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
NUROFEN
®
FOR CHILDREN ORANGE
100 MG/5 ML 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
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. 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. lbuprofen 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

Ficha técnica

Health Products Regulatory Authority
08 March 2021
CRN00C00D
Page 1 of 2
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)
Excipients with known effect
Maltitol syrup
Sodium
Wheat starch
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension
_Product imported from Greece_
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 (contains wheat starch)
Glycerin
Purified Water
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
Health Products Regulatory Authority
08 March 2021
CRN00C00D
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25 °C.
6.5 NATURE AND CONTENTS OF CONTAINER
Amber-coloured bottle with a child-resistant closure fitted with a
liner. The bottle contains 150 ml of product. The bottle has an
insert included in the bottleneck to facilitate the use of the
syringe.
The product is supplied with the following dosing device:
O A 5 ml oral dosing syringe, comprised of an orange piston and a
clear barrel.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
Shake the bottle before use.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/337/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 15
th
August 2014
10 DATE OF REVISION OF THE TEXT
March 2021