Froben 50mg 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:

50mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010100; GTIN: 5016565111230

Patient Information leaflet

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FROBEN 50 MG TABLETS
FROBEN 100 MG TABLETS
Flurbiprofen
IMPORTANT INFORMATION
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 Froben Tablets are and what they are used for
2. What you need to know before you take Froben Tablets
3. How to take Froben Tablets
4. Possible side effects
5. How to store Froben Tablets
6. Contents of the pack and other information
1.
WHAT FROBEN TABLETS ARE AND WHAT THEY ARE USED FOR
Froben 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
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.
Froben Tablets can also be used to treat other painful conditions such
as toothache, pain
after operations, period pain and migraine.
The active substance in Froben Tablets is Flurbiprofen. Froben 50 mg
Tablets contains 50
mg of Flurbiprofen and Froben 100mg Tablets contains 100 mg
of
Flurbiprofen.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FROBEN TABLETS
DO NOT

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Froben Tablets 50 mg
Flurbiprofen 50 mg coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Froben Tablets 50mg contain 50 mg flurbiprofen EP.
Flurbiprofen 50 mg coated tablets contain 50 mg flurbiprofen EP.
3
PHARMACEUTICAL FORM
The tablets are 7.6 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 should