Nurofen for children 100 mg chewable capsules, Soft

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Ibuprofen; Ibuprofen

Prieinama:

Reckitt Benckiser Ireland Ltd

ATC kodas:

M01AE; M01AE01

INN (Tarptautinis Pavadinimas):

Ibuprofen; Ibuprofen

Dozė:

100 milligram(s)

Vaisto forma:

Capsule, soft

Recepto tipas:

Product not subject to medical prescription

Gydymo sritis:

Propionic acid derivatives; ibuprofen

Autorizacija statusas:

Marketed

Leidimo data:

2014-02-14

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE USER
Nurofen for Children
100mg Chewable Capsules, Soft
Ibuprofen
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 advise.
•
If your child gets any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet.
•
You must talk to a doctor if you do not feel better or if you feel
worse after 3 days.
WHAT IS IN THE LEAFLET
1.
What Nurofen for Children 100mg chewable capsules are and what they
are used for
2.
What you need to know before you give Nurofen for Children 100mg
chewable capsules
3.
How to take Nurofen for Children 100mg chewable capsules
4.
Possible side effects
5.
How to store Nurofen for Children 100mg chewable capsules
6.
Contents of the pack and other information
1.
WHAT NUROFEN FOR CHILDREN 100MG CHEWABLE CAPSULES ARE AND WHAT THEY
ARE USED FOR?
The active ingredient (which makes this medicine work) is ibuprofen
which is a non-steroidal anti-
inflammatory (NSAID) painkiller.
Nurofen for Children 100mg chewable are used in
CHILDREN FROM 7 TO 12 YEARS
for the relief of mild to
moderate pain such as a sore throat, dental pain, ear ache, headache,
minor aches and sprains, and symptoms
of cold and flu.
Ibuprofen also brings down a high temperature (fever).
YOU MUST TALK TO A DOCTOR IF YOUR CHILD DOES NOT FEEL BETTER OR IF
YOUR CHILD FEELS WORSE AFTER 3 DAYS.
2.
WHAT YOU NEED TO KNOW BEFORE YOU GIVE NUROFEN FOR CHILDREN 100MG
CHEWABLE CAPSULES
DO NOT GIVE THIS MEDICINE TO YOUR CHILD IF THEY:
•
Are
ALLERGIC
to ibuprofen or any of the other ingredients of this medicine (listed
in section 6)
•
Have ever had a
REACTION
(e.g. asthma, runny nose, rash, swelling of the face, tongue, lips or
throat)
after taking
IBUPROFEN, LOW DO

Prekės savybės

Health Products Regulatory Authority
17 August 2023
CRN00D7K7
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nurofen for children 100 mg chewable capsules, Soft
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable capsule, soft contains 100 mg Ibuprofen.
Excipients with known effect:
Glucose, 358.1 mg per chewable capsule
Sucrose, 251.6 mg per chewable capsule
Soya Lecithin, 0.01 mg per chewable capsule
Sodium, 0.027 mg per chewable capsule
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable capsule, soft.
A orange, square shaped chewable soft gelatin capsule with “N100”
print in white ink. Typical dimensions of the soft gelatin
capsule are approximately 5 to 8 mm in width and approximately 15 to
17 mm in length.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Children from 7 to 12 years
For the reduction of fever and the relief of the symptoms of colds and
influenza and mild to moderate pain, such as a sore
throat, dental pain, earache, headache, minor aches and sprains.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
For short term use only.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration necessary to control
symptoms (see section 4.4).
For pain, fever and symptoms of cold and influenza: The recommended
daily dosage of Nurofen for Children is 20-30 mg/kg
bodyweight in divided doses. This can be achieved as follows:
Children 7 - 9 years: Two capsules may be taken 3 times in 24 hours.
Children 10 – 12 years: Three capsules may be taken 3 times in 24
hours.
Doses should be given approximately every 6 to 8 hours, (or with a
minimum of 6 hours between each dose if required).
Not suitable for children under 7 years of age.
If in children this medicinal product is required for more than 3
days, or if symptoms worsen, a doctor should be consulted.
METHOD OF ADMINISTRATION
For oral administration.
The product should be chewed before swallowing
4.3 CONTRAINDICATIONS
Hypersensitivity to the active