Froben 100mg tablets

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Flurbiprofen

Dostępny od:

Abbott Laboratories Ltd

Kod ATC:

M01AE09

INN (International Nazwa):

Flurbiprofen

Dawkowanie:

100mg

Forma farmaceutyczna:

Oral tablet

Droga podania:

Oral

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 10010100; GTIN: 5016565111223

Charakterystyka produktu

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