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Logo FROBEN SR : Capsules

SCHEDULING STATUS
S3

PROPRIETARY NAME
(and dosage form)

FROBEN SR : Capsules

COMPOSITION
Each hard gelatin capsule contains 200 mg of
flurbiprofen in a sustained release form.

PHARMACOLOGICAL CLASSIFICATION
A3.1/Antirheumatic (anti-inflammatory agent)

PHARMACOLOGICAL ACTION
FROBEN SR is a non-steroidal anti-inflammatory agent which has significant anti-inflammatory, analgesic and anti-pyretic properties. It is an inhibitor of prostaglandin synthetase enzymes which are known to be associated with inflammation, pain and fever. FROBEN SR is a sustained release formulation of flurbiprofen. During a 24 hour period at steady state, mean plasma levels are identical to those achieved with an equivalent daily dose of conventional FROBEN but with a marked reduction in the variation between maximum and minimum plasma concentrations. The elimination half life of flurbiprofen is unchanged (i.e. 3.5 hours), therefore, unlike drugs with intrinsically long half lives, no accumulation occurs with repeat dosing of FROBEN SR.

INDICATIONS
FROBEN SR is indicated for the symptomatic treatment of rheumatoid arthritis, osteoarthritis and ankylosing spondylitis.

CONTRA-INDICATIONS
The use of FROBEN SR is contra-indicated in patients with a history of peptic ulcer and gastro-intestinal bleeding. In patients with impaired hepatic or renal function FROBEN SR should be used with caution.
FROBEN SR should not be given to patients with a history of asthma or to patients who have experienced bronchospasm, anaphylactic reactions, angioedema or other hypersensitivity type reactions from use of aspirin or other non-steroidal anti-inflammatory drugs.
The safety of FROBEN SR during pregnancy and lactation has not been established.

WARNING
This product is not indicated for use in children.

DOSAGE AND DIRECTIONS FOR USE
The recommended daily dose is one 200 mg capsule, to be taken preferably in the evening. The elderly, especially patients with impaired renal function, may eliminate non-steroidals more slowly than normal. In these cases FROBEN SR should be used with caution and the dosage assessed individually.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
The most commonly encountered side-effects include dyspepsia, nausea, headache, gastro-intestinal bleeding and diarrhoea. Urticaria, angioedema and rashes of varying descriptions have also been reported.

Fluid retention and oedema have been reported with flurbiprofen. FROBEN SR should be used with caution in patients with a history of cardiac decompensation and hypertension.

As it has been shown that flurbiprofen may prolong bleeding time, it should be used with caution in patients with a potential for abnormal bleeding.

Possible interactions with oral anticoagulants and phenytoin must also be mentioned.

KNOWN SYMPTOMS OF OVER DOSAGE AND PARTICULARS OF ITS TREATMENT
There is no specific antidote to flurbiprofen. Treat with gastric lavage and if necessary correction of serum electrolytes.

IDENTIFICATION
A hard gelatin capsule with a yellow opaque cap and a transparent yellow body containing white to off white beads, printed 'FSR' in black. Each capsule containing 200 mg flurbiprofen in a sustained release form.

PRESENTATION
Pack of 30 capsules.

STORAGE INSTRUCTIONS
Store below 25°C. Protect from light
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBER
V/3.1/90

NAME AND BUSINESS ADDRESS OF THE APPLICANT
Knoll Pharmaceutocals (S.A.) (Pty) Ltd
P.O. Box 3030, Halfway House 1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT
3 March 1989                        Code No.: 4468
                                                Davbar Dbn.

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