Nurofen for Children Meltlets 100mg Orodispersible Tablets

Pajjiż: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Ibuprofen

Disponibbli minn:

Reckitt Benckiser Ireland Ltd

Kodiċi ATC:

M01AE; M01AE01

INN (Isem Internazzjonali):

Ibuprofen

Dożaġġ:

100 milligram(s)

Għamla farmaċewtika:

Orodispersible tablet

Tip ta 'preskrizzjoni:

Product not subject to medical prescription

Żona terapewtika:

Propionic acid derivatives; ibuprofen

L-istatus ta 'awtorizzazzjoni:

Not marketed

Data ta 'l-awtorizzazzjoni:

2004-07-30

Fuljett ta 'informazzjoni

Nurofen for Children
Meltlets 100mg Orodispersible Tablets
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,
PHARMACIST OR NURSE 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, pharmacist
or nurse. 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 Meltlets are and what are they used for
2.
What you need to know before giving Nurofen for Children Meltlets to
your child
3.
How to use Nurofen for Children Meltlets
4.
Possible side-effects
5.
How to store Nurofen for Children Meltlets
6.
Contents of the pack and other information
1.
WHAT NUROFEN FOR CHILDREN MELTLETS ARE AND WHAT ARE THEY USED FOR?
The active ingredient (which makes this medicine work) is ibuprofen
which is a 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 Meltlets also reduces a high
temperature (fever).
2.
WHAT YOU NEED TO KNOW BEFORE GIVING NUROFEN FOR CHILDREN MELTLETS TO
YOUR CHILD
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)

Karatteristiċi tal-prodott

Health Products Regulatory Authority
13 January 2023
CRN00D5XN
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nurofen for Children Meltlets 100mg Orodispersible Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible table contains ibuprofen 100 mg
Excipients with known effects:
Sodium 1.98 mg (0.09 mmol) per tablet
Aspartame 12 mg per tablet
Sorbitol less than 6 mg per tablet
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Orodispersible tablets
White to off-white round tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Reduction of fever and relief of mild to moderate pain, such as cold
and flu symptoms, toothache, 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.
For pain and fever: The daily dosage of Nurofen for Children Meltlets
is 20 to 30 mg of Ibuprofen/kg bodyweight in divided
doses.
The recommended dose should not be exceeded.
Not suitable for children weighing less than 20kg.
This can be achieved as follows:
BODY WEIGHT
APPROXIMATE AGE
RECOMMENDED DOSAGE
20-30 kg
6 – 9 years
Initial dose 2 tablets, then if necessary 2 tablets every 4 – 6
hours. Do not exceed 6
tablets in a 24 hour period.
31-40 kg
10 -12 years
Initial dose 3 tablets, then if necessary 3 tablets every 4-6 hours.
Do not exceed 9 tablets
in a 24 hour period.
If in children aged from 6 years and in adolescents this medicinal
product is required for more than 3 days, or if symptoms
worsen a doctor should be consulted.
The lowest effective dose should be used for the shortest duration
necessary to relieve symptoms (see Section 4.4).
METHOD OF ADMINISTRATION
For oral administration. Place a tablet on the tongue, allow it to
dissolve and then swallow; no water is required.
4.3 CONTRAINDICATIONS
Health Products Regulatory Authority
13 January 2023
CRN00D5XN
Page 2 of 8
Hypersensitivity to ibuprofen or to any of the excipients listed in
section 6.1.
Patients wh