Nurofen for Children Cold, Pain and Fever Orange Flavour 100mg/5ml oral suspension

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)

العنصر النشط:

Ibuprofen

متاح من:

Reckitt Benckiser Healthcare (UK) Ltd

ATC رمز:

M01AE01

INN (الاسم الدولي):

Ibuprofen

جرعة:

20mg/1ml

الشكل الصيدلاني:

Oral suspension

طريقة التعاطي:

Oral

الفئة:

No Controlled Drug Status

نوع الوصفة الطبية :

Valid as a prescribable product

ملخص المنتج:

BNF: 10010100; GTIN: 5000158069770

نشرة المعلومات

Package Leaflet: Information for the user
Contains Ibuprofen
This leaflet is valid for Nurofen for Children Cold,
Pain and Fever Orange flavour or for Nurofen for
Children Cold, Pain and Fever Strawberry flavour.
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

خصائص المنتج

OBJECT 1
NUROFEN FOR CHILDREN COLD, PAIN AND FEVER
ORANGE FLAVOUR 100MG/5ML ORAL SUSPENSION
Summary of Product Characteristics Updated 07-Jun-2018 | Reckitt
Benckiser Healthcare (UK) Ltd
1. Name of the medicinal product
Nurofen for Children Orange
Nurofen for Children Orange Baby
Nurofen for Children 3 months to 9 years Orange
Nurofen for Children Cold, Pain and Fever Orange 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, orange-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
(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 take