Nurofen for Children Cold & Flu & Pain Orange 100mg/5ml Oral Suspension

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Ibuprofen

Dostupné s:

Reckitt Benckiser Ireland Ltd

ATC kód:

M01AE; M01AE01

INN (Mezinárodní Name):

Ibuprofen

Dávkování:

100 mg/5ml

Léková forma:

Oral suspension

Druh předpisu:

Product not subject to medical prescription

Terapeutické oblasti:

Propionic acid derivatives; ibuprofen

Stav Autorizace:

Not marketed

Datum autorizace:

2014-10-24

Informace pro uživatele

NUROFEN FOR CHILDREN COLD & FLU & PAIN ORANGE
100MG/5ML ORAL SUSPENSION
ibuprofen
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU USE THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR
YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told you.
Keep this leaflet. You may need to read it again
Ask your pharmacist if you need more information or advice.
If your child gets any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4
You must talk to a doctor if your child does not feel better or if
your child feels worse after 3 days.
WHAT IS IN THIS LEAFLET
1.
What Nurofen for Children Cold & Flu & Pain is and what it is used for
2.
Before giving Nurofen for Children Cold & Flu & Pain to your child
3.
How to use Nurofen for Children Cold & Flu & Pain
4.
Possible side effects
5.
How to store Nurofen for Children Cold & Flu & Pain
6.
Further information
1.
WHAT NUROFEN FOR CHILDREN COLD & FLU & PAIN IS AND WHAT IT IS USED FOR
The active ingredient (which makes this medicine work) is ibuprofen
which is an 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 Cold & Flu & Pain also reduces a high temperature
(fever).
2.
WHAT YOU NEED TO KNOW BEFORE GIVING NUROFEN FOR CHILDREN COLD & FLU &
PAIN
This medicine is suitable for the majority of people but certain
people should not use it. Talk to your pharmacist
or doctor if you are at all unsure.
DO NOT GIVE THIS MEDICINE TO YOUR CHILD IF:
They suffer from hypersensitivity to any of the ingredients in this
medicine (See section 6).
They have EVER HAD A REACTION (e.g. asthma, runny nose, rash, swelling
of the face, tongue, lips or throat
or stomach bleeding) AFTER TAKING IBUPROFEN, ASPIRIN OR OTHER
NON-STEROIDAL ANTI-INFLAMMATORY (NSAID)
ME

Charakteristika produktu

Health Products Regulatory Authority
13 January 2023
CRN00D5XN
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nurofen for Children Cold & Flu & Pain Orange 100mg/5ml Oral
Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen 100 mg/5 ml (equivalent to 2.0% w/v)
Excipients with known effects:
Maltitol liquid 2226 mg per 5 ml
Sodium 9.08 mg (0.39 mmol) per 5 ml
Wheat starch 11 mg, containing no more than 0.225 µg gluten per 5 ml
For 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 Cold & Flu & Pain is
30mg 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 10mg/kg body
weight as single dosage.
This can be achieved as follows:
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 dose more frequently than at 6 hourly intervals. The
re