Nurofen for Children 100mg/5ml oral suspension strawberry

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Ibuprofen

Tilgængelig fra:

Reckitt Benckiser Healthcare (UK) Ltd

ATC-kode:

M01AE01

INN (International Name):

Ibuprofen

Dosering:

20mg/1ml

Lægemiddelform:

Oral suspension

Indgivelsesvej:

Oral

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 10010100; GTIN: 5000158100589 5000158100695

Indlægsseddel

Package Leaflet: Information for the user
Contains Ibuprofen
This leaflet is valid for Nurofen for Children
3 months to 9 years Orange or for Nurofen for
Children 3 months to 9 years Strawberry.
The only difference between both products is
the flavour. To know the flavour of the medicine
you are using, please refer to the carton or label.
Read all of this leaflet carefully before you
use this medicine, because it contains
important information for you.
Keep this leaflet: you might need it again.
Ask your doctor or pharmacist if you need more
information or advice.
• This medicine is designed to help bring down a
high temperature (fever and post-immunisation
fever), relieve the symptoms of cold and flu and
relieve pain from headaches, sore throats, minor
aches and sprains, teething and toothache.
• This medicine is suitable for most babies over
3 months of age, children and adults.
• Follow the dose instructions carefully.
Section 3 shows the different amount 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 aspirin at a dose above 75 mg a
day. See Section 2
is taking other medicines. See Section 2.
is not getting better, or feeling worse, or you
feel at all concerned. See Section 3
develops a rash, breathing problems or
diarrhoea and gets very tired. See Section 3.
gets any side effects. See Section 4. This includes
any possible side effects not listed in this leaflet.
• 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. What you need to know 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 pack and other information
1. What Nurofen for Children is and
what it is used for
The active ingredient (which makes this medicine
work

Produktets egenskaber

OBJECT 1
NUROFEN FOR CHILDREN STRAWBERRY BABY
Summary of Product Characteristics Updated 07-Jun-2018 | Reckitt
Benckiser Healthcare (UK) Ltd
1. Name of the medicinal product
Nurofen for Children Strawberry Baby
Nurofen for Children 3 months to 9 years Strawberry
Nurofen for Children Cold, Pain and Fever Strawberry Flavour 100mg/5mL
Oral Suspension
2. Qualitative and quantitative composition
Ibuprofen 100 mg/5ml (equivalent to 2.0% w/v).
Excipients with known effect:
Maltitol Liquid
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral suspension.
An off-white, strawberry-flavoured, syrupy suspension.
4. Clinical particulars
4.1 Therapeutic indications
Prescription and OTC: For the fast and effective reduction of fever,
including post immunisation pyrexia
and the fast and effective relief of the symptoms of colds and
influenza and mild to moderate pain, such
as a sore throat, teething pain, toothache, headache, minor aches and
sprains.
4.2 Posology and method of administration
POSOLOGY
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration
necessary to control symptoms (see section 4.4).
For short term use only.
The recommended daily dose of the product is 20 – 30 mg per kg of
body weight, divided into equal
doses, with dosing intervals of 6 to 8 hours. Leave at least 4 hours
between doses and do not take more
than the recommended dose in 24 hours. The recommended dose should not
be exceeded. Using the
spoon or syringe dosing device provided this can be achieved as
follows:
Age
Body weight
Recommended Dosage
(kg)
Infants 3-6 months weighing
more than 5 kg
5-7.6
one 2.5ml dose may be taken 3 times
in 24 hours
Infants 6-12 months
7.7-9
one 2.5ml dose may be taken 3 to 4
times in 24 hours
Children 1-3 years
10-16
one 5ml dose may be taken 3 times
in 24 hours
Children 4-6 years
17-20
7.5ml (5ml +2.5ml spoonful) may be
taken 3 times in 24 hours
Children 7-9 years
21-30
two 5ml doses may be taken 3 times
in 24 hours
Not suitable for children under 3 mo