Nurofen for Children 100mg/5ml Oral Suspension

Land: Malta

Sprache: Englisch

Quelle: Medicines Authority

Wirkstoff:

IBUPROFEN

Verfügbar ab:

NeoFarma Pharmaceuticals Limited 42-46, Mill Street, Qormi, QRM 3105, Malta

ATC-Code:

M01AE01

INN (Internationale Bezeichnung):

IBUPROFEN 100 mg/5ml

Darreichungsform:

ORAL SUSPENSION

Zusammensetzung:

IBUPROFEN 100 mg/5ml

Verschreibungstyp:

OTC

Therapiebereich:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Produktbesonderheiten:

Licence number in the source country: Greece - 46452/18-07-2012

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2014-01-08

Gebrauchsinformation

PACKAGE LEAFLET: INFORMATION FOR THE USER
NUROFEN FOR CHILDREN 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 d

Fachinformation

Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nurofen for Children 100 mg/5 ml oral suspension
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of oral suspension contains 20 mg ibuprofen. Excipients with
known effect:
Liquid maltitol: 445.2 mg/mL
Sodium: 1.82 mg/mL equivalent to 0.08 mmol/mL.
Wheat starch (component of orange flavor, contains gluten ): 2.2 mg of
wheat starch containing no more than 0.045
micrograms/ml of gluten.
For the 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