Brupro for Children 100 mg/5 ml oral suspension

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Ibuprofen

Tersedia dari:

Rowa Pharmaceuticals Limited

Kode ATC:

M01AE01

INN (Nama Internasional):

Ibuprofen

Bentuk farmasi:

Oral suspension

Area terapi:

ibuprofen

Status otorisasi:

Marketed

Tanggal Otorisasi:

2022-03-11

Selebaran informasi

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BRUPRO FOR CHILDREN 100 MG/5 ML 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, 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 you or your child get 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 YOU OR YOUR CHILD DO NOT FEEL BETTER OR
IF YOU OR YOUR CHILD FEEL
WORSE AFTER 3 DAYS (NOT LATER THAN 24 HOURS IN CASE OF INFANTS 3 TO 5
MONTHS OF AGE).
WHAT IS IN THIS LEAFLET
1.
What Brupro for Children is and what it is used for
2.
What you need to know before you use Brupro for Children
3.
How to use Brupro for Children
4.
Possible side effects
5.
How to store Brupro for Children
6.
Contents of the pack and other information
1.
WHAT BRUPRO FOR CHILDREN IS AND WHAT IT IS 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. Brupro for Children also reduces a high
temperature (fever).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BRUPRO FOR CHILDREN
DO NOT GIVE BRUPRO FOR CHILDREN TO CHILDREN WHO:
•
ARE LESS THAN 3 MONTHS OLD OR WEIGH LESS THAN 5 KG.
•
are
ALLERGIC TO IBUPROFEN OR OTHER SIMILAR PAINKILLERS (NSAIDS)
or to any of the other
ingredients of this medicine (listed in section 6)
•
have ever suffered from shortness of breath, asthma, a runny nose,
swelling on their face
and/or hands or hives after
using acetylsalicylic acid (ASPIRIN)
or
OTHER SIMILAR PAINKILLERS
(NSAIDS)
•
have ever had
GASTROIN

Karakteristik produk

Health Products Regulatory Authority
26 February 2024
CRN00DZC8
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Brupro for Children 100 mg/5 ml oral suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml oral suspension contains 100 mg ibuprofen.
Excipients with known effect
Each 5 ml oral suspension contains 140 mg sorbitol, 50 mg propylene
glycol, 10 mg sodium benzoate and 5.25 mg ethanol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension
White or almost white 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 Brupro for Children is 30 mg 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 10 mg/kg body weight as single
dosage.
This can be achieved as follows:
Age and/or bodyweight can be used as a guide to select the correct
dose.
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.
Do not dose more frequently than at 6 hourly intervals. The
recommended dose should not be exceeded.
For short term use only.
For infants aged 3-5 months medical advice should be sought if
symptoms worsen or not later than 24 hours if symptoms
persist.
Health Products Regulatory Authority
26 February 2024
CRN00DZC8
Page 2 of 12
If in children a