Brufen Paediatric 100mg/5ml Oral Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ibuprofen

Available from:

Viatris Healthcare Limited

ATC code:

M01AE01

INN (International Name):

Ibuprofen

Pharmaceutical form:

Oral suspension

Therapeutic area:

ibuprofen

Authorization status:

Marketed

Authorization date:

1981-03-02

Patient Information leaflet

Package leaflet: Information for the user
BRUFEN
® PAEDIATRIC 100MG/5ML ORAL SUSPENSION
ibuprofen
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU
•
Keep this leaflet. You may need to read it again.
•
If you have further questions ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it to
others. It may
harm them even if their signs of illness are the same as yours.
•
If you get any side effects talk to your doctor, pharmacist or nurse.
This includes
any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1.
What Brufen is and what it is used for
2.
What you need to know before you take Brufen
3.
How to take Brufen
4.
Possible side effects
5.
How to store Brufen
6.
Contents of the pack and other information
The full name of your medicine is BRUFEN PAEDIATRIC ORAL SUSPENSION.
In this leaflet,
the shorter name Brufen is used.
1. WHAT IS BRUFEN AND WHAT IT IS USED FOR
Brufen belongs to a group of medicines called anti-inflammatory pain
killers.
The active ingredient in Brufen is ibuprofen and each 5ml spoonful
contains 100mg of
ibuprofen.
It can be used to relieve pain and inflammation in conditions such as
osteoarthritis,
rheumatoid arthritis (including juvenile rheumatoid arthritis or
Still's disease), arthritis of
the spine (ankylosing spondylitis), swollen joints, frozen shoulder,
bursitis, tendonitis,
tenosynovitis, lower back pain, sprains and strains.
Brufen can also be used to lower temperature and to treat other
painful conditions such
as toothache, pain after operations, period pain and headache,
including migraine and to
reduce fever in children.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BRUFEN
DO NOT TAKE BRUFEN
•
if you are allergic to ibuprofen or any of the ingredients of this
medicine(listed in
section 6)
•
if you previously experienced stomach bleeding or perforation after
taking
ibuprofen or other non-steroidal anti-inflammatory drugs (NS

Summary of Product characteristics

Health Products Regulatory Authority
17 January 2024
CRN00F259
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Brufen Paediatric 100mg/5ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml contains 100mg ibuprofen
Excipients with known effect: Each 5ml also contains:
5mg methyl parahydroxybenzoate (E218)
2.5mg propyl parahydroxybenzoate (E216)
500mg sorbitol solution non-crystallising (E420)
3.3 g sucrose
0.5mg sunset yellow FC edicol (E110)
12.5mg sodium benzoate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension.
Orange-coloured and flavoured syrup-like suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Brufen Paediatric Oral Suspension is indicated in the management of
various arthroses such as rheumatoid arthritis (including
juvenile rheumatoid arthritis or Still’s Disease) and
osteoarthritis, fibrositis, ankylosing and other muscular syndromes
such as
low back pain, soft tissue trauma and various inflammations of tendon,
joint capsules and ligaments.
As an analgesic in the relief of mild to moderate pain.
Ibuprofen is indicated for the treatment of pyrexia in children.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The lowest effective dose should be used for the shortest duration
necessary to relieve symptoms (see section 4.4).
ADULTS AND ADOLESCENTS OLDER THAN 12 YEARS (≥ 40KG)
The recommended dosage of Brufen is 1200-1800 mg daily in divided
doses. Some patients can be maintained on 600-1200
mg daily. Total daily dose should not exceed 2400 mg.
PAEDIATRIC POPULATION
The recommended dose of Brufen is 20-30 mg per kg of bodyweight daily
in divided doses. This can be achieved by using the
suspension as follows:
Age/weight
Frequency
Single dose
3-6 months
(~5-7kg)
Up to 3 times a day
2.5ml
(50mg)
6-12 months
(~7-10kg)
3 times a day
2.5ml
(50mg)
1 to 2 years
3 to 4 times a day
2.5ml
Health Products Regulatory Authority
17 January 2024
CRN00F259
Page 2 of 11
(~10-14.5kg)
(50mg)
3 to 7 years
(~14.5-25kg)
3