Flurbiprofen 100mg tablets

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Flurbiprofen

Verfügbar ab:

Viatris UK Healthcare Ltd

ATC-Code:

M01AE09

INN (Internationale Bezeichnung):

Flurbiprofen

Dosierung:

100mg

Darreichungsform:

Oral tablet

Verabreichungsweg:

Oral

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 10010100; GTIN: 5016695005140

Gebrauchsinformation

FM-H8012891_d1
PAGE 1
1
Flurbiprofen 50 mg Tablets
Flurbiprofen 100 mg Tablets
Flurbiprofen
IMPORTANT INFORMATION
Read all this leaflet carefully
before you start taking this
medicine
• Keep this leaflet as you may
need to read it again
• This leaflet provides a
summary of the information
currently available about
Flurbiprofen Coated Tablets
• For further information or
advice ask your doctor or
pharmacist
• This medicine is for you only
and should never be given
to anyone else, even if they
appear to have the same
symptoms as you
• Tell your doctor or
pharmacist if you experience
any serious side effects or
any side effects that are not
listed in this leaflet.
Leaflet contents:
1. What are Flurbiprofen Coated Tablets and
what are they used for?
2. What should you know before taking
Flurbiprofen Coated Tablets?
3. How should you take Flurbiprofen Coated
Tablets?
4. Possible side effects of Flurbiprofen
Coated Tablets.
5. How to store Flurbiprofen Coated Tablets.
6. Further information about Flurbiprofen
Coated Tablets.
1. What are Flurbiprofen Coated Tablets
and what are they used for?
Flurbiprofen Coated Tablets belong to a
group of medicines called non-steroidal anti-
inflammatory drugs (NSAIDs). They can be
used to relieve pain and inflammation (redness,
heat and swelling) in conditions such as:
•
osteoarthritis (a bone disorder, which is
seen mostly in older persons, in which the
joints become painful and stiff)
•
rheumatoid disease (inflammation of
the joints and sometimes surroundings
tissues)
•
ankylosing spondylitis (arthritis of the
spine)
•
swollen joints, frozen shoulder, bursitis
(inflammation of the bursa), tendinitis
(inflammation of tendons), tenosynovitis
(inflammation of the covering layer of a
tendon)
•
low back pain, sprains and strains.
Flurbiprofen Coated Tablets can also be
used to treat other painful conditions such as
toothache, pain after operations, period pain
and migraine.
The active substance in Flurbiprofen Coated
Tablets is flurbiprofen "EP". Flurbiprofen
50 mg C

Fachinformation

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