Froben 100mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Flurbiprofen

Available from:

Abbott Laboratories Ltd

ATC code:

M01AE09

INN (International Name):

Flurbiprofen

Dosage:

100mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010100; GTIN: 5016565111223

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Froben Tablets 100 mg
Flurbiprofen 100 mg coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Froben Tablets 100 mg contain 100 mg flurbiprofen EP.
Flurbiprofen 100 mg coated tablets contain 100 mg flurbiprofen EP.
3
PHARMACEUTICAL FORM
The tablets are 10.0 mm in diameter, sugar-coated and white in colour.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of rheumatoid disease, osteoarthritis, ankylosing
spondylitis,
musculoskeletal disorders and trauma such as periarthritis, frozen
shoulder,
bursitis, tendinitis, tenosynovitis, low back pain, sprains and
strains.
Flurbiprofen is also indicated for its analgesic effect in the relief
of mild to
moderate pain in conditions such as dental pain, post-operative pain,
dysmenorrhoea and migraine.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration. To be taken preferably with or after food.
Undesirable effects may be minimised by using the lowest effective
dose for
the shortest duration necessary to control symptoms (see Section 4.4).
_Adults_:
150 to 200 mg daily in two, three or four divided doses. In patients
with severe
symptoms or disease of recent origin, or during acute exacerbations,
the total
daily dosage may be increased to 300 mg in divided doses.
For dysmenorrhoea, a dosage of 100 mg may be administered at the start
of
symptoms followed by 50 or 100 mg given at four- to six-hour
intervals. The
maximum total daily dosage should not exceed 300 mg.
_Paediatric population_:
Not recommended for use in children under 12 years.
_Older people _:
The elderly are at increased risk of the serious consequences of
adverse
reactions. Although flurbiprofen is generally well tolerated in the
elderly,
some patients, especially those with impaired renal function, may
eliminate
NSAIDs more slowly than normal. In these cases, flurbiprofen should be
used
with caution and dosage should be assessed individually.
If an NSAID is considered necessary, the lowest effective dose sh