Nurofen for Children Singles 100mg/5ml oral suspension 5ml sachets strawberry

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ibuprofen

Available from:

Reckitt Benckiser Healthcare (UK) Ltd

ATC code:

M01AE01

INN (International Name):

Ibuprofen

Dosage:

20mg/1ml

Pharmaceutical form:

Oral suspension

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010100; GTIN: 5000167070095 5000167070101

Patient Information leaflet

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WARNING:
Do not take more medicine than the
label or leaflet tells you to
Contains Ibuprofen
This leaflet is valid for Nurofen for Children
Orange Singles or for Nurofen for Children
Strawberry Singles. 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) and relieves 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 Singles is and
what it is used for
2. What you need to know before giving
Nurofen for Children Singles to your child
3. How to use Nurofen for Children Singles
4. Possible side effects
5. How to store Nurofen
for Children Singles
6. Contents of pack and
other information
1. What Nurofen for
Children Singles
is and what it is
used for
The active ingredie

Summary of Product characteristics

OBJECT 1
NUROFEN FOR CHILDREN STRAWBERRY SINGLES
Summary of Product Characteristics Updated 07-Jun-2018 | Reckitt
Benckiser Healthcare (UK) Ltd
1. Name of the medicinal product
Nurofen for Children Strawberry Singles
2. Qualitative and quantitative composition
Ibuprofen 100mg/ 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
For the treatment of rheumatic or muscular pain, headache, dental
pain, feverishness, or symptoms of
colds and influenza.
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
(KG)
RECOMMENDED DOSAGE
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
Children 10-12 years
31-40
three 5ml doses may be taken 3
times in 24 hours
Not suitable for children under 3 months of age.
Do not use this product in children weighing less than 5 kg.
For infants aged 3-6 months medical advice should be sought if
symptoms worsen or not later than 24
hours if symptoms persist.
If in children aged fro