Flurbiprofen 50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Flurbiprofen

Available from:

Kent Pharma (UK) Ltd

ATC code:

M01AE09

INN (International Name):

Flurbiprofen

Dosage:

50mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010100

Patient Information leaflet

PATIENT LEAFLET: INFORMATION FOR THE USER
Flurbiprofen 50 mg or 100 mg Tablets
Flurbiprofen
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 any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on 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 or pharmacist. This
includes
any possible side effects not listed in this leaflet (See section 4).
What is in this leaflet
1. What Flurbiprofen is and what it is used for
2. What you need to know before you take Flurbiprofen
3. How to take Flurbiprofen
4. Possible side effects
5. How to store Flurbiprofen
6. Contents of the pack and other information
1. What Flurbiprofen is and what it is used for
The name of your medicine is Flurbiprofen 50 mg or 100 mg Tablets. The
active
ingredient is Flurbiprofen.
Flurbiprofen belongs to a group of medicines called non-steroidal
anti- inflammatory
drugs (NSAIDs). It 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
surrounding
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 can also be used to treat other painful conditions such
as toothache,
pain after operations, period pain and migraine.
2. What you need to know before you take Flurbiprofen
Do not take this medicine if:
•
You are sensitive (allergic) to any of the ingredients in the tablets
listed in Section
6. Ingredi

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Flurbiprofen 50mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg Flurbiprofen
Excipients with known effect: Also contains sucrose 82.40 mg , glucose
1.3
mg, lactose 37.50 mg and sunset yellow (E110).
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Coated Tablet.
The tablets are sugar-coated and yellow 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
Posology:
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 of disease of recent origin, or during acute exacerbations,
the total daily
dosage may be increased to 300mg in divided doses.
For
dysmenorrhoea,
a
dosage
of
100mg
may
be
administered
at
the
start
of
symptoms, followed by 50 or 100 mg given at four – to six – hourly
intervals.
The maximum total daily dosage should not exceed 300mg.
Paediatric population:
Flurbiprofen is not recommended for use in children under 12 years.
Elderly:
The elderly are at 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 shoul