FROBEN 50 : Tablets
FROBEN 100 : Tablets
FROBEN : Suppositories
SCHEDULING STATUS
Schedule 3
PROPRIETARY NAME
(and dosage form)
FROBEN 50 : Tablets
FROBEN 100 : Tablets
FROBEN : Suppositories
COMPOSITION
Tablets 50 mg : Each sugar coated tablet contains 50 mg flurbiprofen
100 mg : Each sugar coated tablet contains 100 mg flurbiprofen
Suppositories : Each suppository contains 100 mg flurbiprofen
PHARMACOLOGICAL CLASSIFICATION
A3.1/Antirheumatic (anti-inflammatory agent).
PHARMACOLOGICAL ACTION
FROBEN, chemically described as 2-(2-fluoro-4-biphenylyl) propionic acid, is a non-steroidal anti-inflammatory agent which has significant anti-inflammatory, analgesic and antipyretic properties. FROBEN is an inhibitor of prostaglandin synthetase enzymes which are known to be associated with inflammation, pain and fever.
INDICATIONS
FROBEN is indicated in the treatment of rheumatoid arthritis, osteo-arthritis and ankylosing spondylitis. FROBEN is also indicated for the relief of pain following soft tissue trauma, dental surgery, dysmenorrhoea, post episiotomy pain and post partum pain.
CONTRA-INDICATIONS
FROBEN should not be given to patients with peptic ulceration. The safety of FROBEN during pregnancy or lactation has not been established. FROBEN should be prescribed with caution for those patients with asthma, and especially for patients who have developed bronchospasm with other non-steroidal agents. Should not be given to patients sensitive to aspirin.
WARNINGS
DO NOT USE THESE PRODUCTS IN CHILDREN UNDER 12 YEARS OF AGE.
DOSAGE AND DIRECTIONS FOR USE
The average recommended daily dosage is 200 mg taken as one 100 mg tablet twice a day.
In patients with severe symptoms or disease of recent origin, or during acute exacerbations, the total daily dosage may be increased to 300 mg taken as one 100 mg tablet three times a day. In place of the oral night-time dose, one suppository may be inserted into the rectum at night. It is recommended not to take the suppository continuously for longer than a month.
THE PRODUCTS ARE NOT INDICATED FOR USE IN CHILDREN.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Dyspepsia, heartburn and headache are the commonest side-effects encountered as well as skin rashes and gastrointestinal ulceration. Care should be taken when administering the medicine to patients with asthma or who have experienced bronchospasm with other anti-inflammatory or analgesic agents. FROBEN must be given with care to patients with bleeding disorders, cardiovascular disease, peptic ulceration or a history of such ulceration. Possible interaction with oral anti-coagulants and phenytoin must also be mentioned. The suppositories may cause local discomfort or irritation which is usually not serious and does not necessitate withdrawal from treatment.
Acute allergic reactions have been reported.
Because of the possibility of cross-sensitivity due to structural relationships which exist among non-steroidal anti-inflammatory medicines, acute allergic reactions may be more likely to occur in patients who have exhibited allergic reactions to these compounds. Dizziness, nervousness and other central effects, hypersensitivity, depression, drowsiness, nausea and vomiting, diarrhoea, oedema and tinnitus may occur. Some cases of thrombocytopenia and agranulocytosis have been reported, and toxic amblyopia has occurred. Abnormalities of liver function tests and impairment of renal function have been observed. In the elderly, especially patients with impaired renal function, non-steroidal anti-inflammatory medicines may be eliminated more slowly than normal. In these cases FROBEN should be used with caution and the dosage be assessed individually.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
The most likely symptoms of overdosage are epigastric pain and nausea. Treatment consists of gastric lavage and, if necessary, correction of serum electrolytes. There is no specific antidote to flurbiprofen.
IDENTIFICATION
Tablets 50 mg and 100 mg : Sugarcoated polished white tablets overprinted F50 and F100 in black on one side.
Suppository : A hard creamy-white waxy solid.
PRESENTATION
FROBEN tablets 50 mg : Carton containing 100 blister packed tablets
FROBEN tablets 100 mg : Carton containing 15 and 50 blister packed tablets
FROBEN Suppositories : Carton containing 12 suppositories
STORAGE INSTRUCTIONS
Tablets: Store below 25°C in a dry place.
Suppositories: Store below 25°C, do not freeze.
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER
FROBEN tablets 50mg : K/3.1/4
100 mg : K/3.1/5
FROBEN Suppositories 100 mg : Q/3.1/260
NAME AND BUSINESS ADDRESS OF THE APPLICANT
Knoll Pharmaceuticals (S.A.) (Pty) Ltd
P.O. Box 3030 Halfway House 1685
DATE OF PUBLICATION OF THIS PACKAGE INSERT
15 March 1991 Davbar Dbn. 3116/A |
