Brufen 100mg/5ml syrup

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ibuprofen

Available from:

Viatris UK Healthcare Ltd

ATC code:

M01AE01

INN (International Name):

Ibuprofen

Dosage:

20mg/1ml

Pharmaceutical form:

Oral suspension

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010100; GTIN: 5016565111056

Summary of Product characteristics

OBJECT 1
BRUFEN SYRUP
Summary of Product Characteristics Updated 12-Sep-2016 | Mylan
Products Limited
1. Name of the medicinal product
Brufen Syrup
2. Qualitative and quantitative composition
Ibuprofen BP 100 mg/5 ml
Excipients with known effect: Sucrose 3.3g, sorbitol 0.5g, sunset
yellow 0.5mg, methyl
parahydroxybenzoate 5mg, propyl parahydroxybenzoate 2.5mg.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
An orange-coloured, orange-flavoured, syrupy suspension.
4. Clinical particulars
4.1 Therapeutic indications
Brufen Syrup is indicated for its analgesic and anti-inflammatory
effects in the treatment of rheumatoid
arthritis (including juvenile rheumatoid arthritis or Still's
disease), ankylosing spondylitis, osteoarthritis
and other non-rheumatoid (seronegative) arthropathies.
In the treatment of non-articular rheumatic conditions, Brufen Syrup
is indicated in peri-articular
conditions such as frozen shoulder (capsulitis), bursitis, tendinitis,
tenosynovitis and low back pain;
Brufen Syrup can also be used in soft-tissue injuries such as sprains
and strains.
Brufen Syrup is also indicated for its analgesic effect in the relief
of mild to moderate pain such as
dysmenorrhoea, dental and post-operative pain and for symptomatic
relief of headache including migraine
headache.
Brufen Syrup is indicated in short-term use for the treatment of
pyrexia in children over one year of age.
4.2 Posology and method of administration
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration
necessary to control symptoms (see section 4.4).
Adults and children over 12 years of age : 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.
Children: The daily dosage of Brufen is 20 mg/kg of bodyweight in
divided doses. This can be achieved
as follows:
1-2 years: One 2.5 ml spoonful (50 mg) three to four times a day.
3-7 years: One 5 ml spoonful (100 mg)