INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo APO-FLURBIPROFEN 50 mg (film coated tablets)
APO-FLURBIPROFEN 100 mg (firm coated tablets)

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

APO-FLURBIPROFEN 50 mg (film coated tablets)
APO-FLURBIPROFEN 100 mg (firm coated tablets)

COMPOSITION
APO-FLURBIPROFEN 50 tablets: Each film coated tablet contains
flurbiprofen 50 mg.
APO-FLURBIPROFEN 100 tablets Each film coated tablet contains flurbiprofen 50 mg.

PHARMACOLOGICAL CLASSIFICATION
A.3.1 Antirheumatics (anti-inflammatory agents).

PHARMACOLOGICAL ACTION
Flurbiprofen chemically described as 2-(2-fluoro-4-biphenylyl) pripionic acid, is a non-steroidal anti-inflammatory agent which has anti-inflammatory, analgesic and antipyretic properties. Flurbiprofen is an inhibitor of cyclo-oxygenase responsible for the biosynthesis of prostaglandins, which are known to be associated with inflammation, pain and fever.
Pharmacokinetics
Flurbiprofen is readily observed from the gastro-intestinal tract with peak plasma concentrations occurring about 1 to 20 hours after ingestion. It is about 99% bound to plasma proteins and has a plasma half-life of about 3 to 6 hours. It is mainly metabolised by hydroxylation and conjugation in the liver and excreted in the urine.

INDICATIONS
APO-FLURBIPROFEN is indicated in the treatment of rheumatoid arthritis, osteoarthiritis and ankylosing spondylitis. APO-FLURBIPROFEN is also indicated for relief of mild to moderate pain following soft tissue trauma, dental surgery, dysmenorrhoea, postepisiotomy pain, post-partum pain.

CONTRA-INDICATIONS
Hypersensitivity to any of the components. APO-FLURBIPROFEN should not be given to patients with peptic ulceration. The safety of APO-FLURBIPROFEN during pregnancy or lactation has not been established. Patients who are hypersensitive to aspirin or other non steroidal anti-inflammatory agents.

WARNINGS
DO NOT USE THESE PRODUCTS IN CHILDREN UNDER 12 YEARS OF AGE. APO-FLURBIPROFEN should be prescribed with caution for those patients with asthma, and especially for patients who have developed bronchospasm with other non-steroidal agents. Regular use of non-steroidal anti-inflammatory agents during the third trimester of pregnancy may result in premature closure of the feotal ductus arteriosus in utero and possibly in persistent pulmonary hypertension of the newborn. The onset of labour may be delayed and its duration increased.

DOSAGE AND DIRECTIONS FOR USE
The average recommended daily dosage is 150 mg - 200 mg in divided doses, increased to 300 mg daily in acute conditions, taken as one 100 mg tablet three times per day.
APO-FLURBIPROFEN IS NOT INDICATED FOR USE IN CHILDREN.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Gastro-intestinal disturbances, reactions ranging from abdominal discomfort and pain to serious gastro-intestinal bleeding or activation of peptic ulcer, nausea and vomiting, dyspepsia, heartburn and headaches are the most frequent adverse effects encountered as well as skin rashes.
Due to the possibility of cross-sensitivity because of 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, insomnia, nausea and vomiting, diarrhoea, oedema and tinnitus may occur.
Hypersensitivity reactions may occur occasionally and include fever, asthma and rashes. Hepatoxicity and aseptic meningitis which occur less frequently may also be hypersensitivity reactions. Some patients may experience visual disturbances. Flurbiprofen may cause cystitis, haematuria, renal failure, nephrotic syndrome and intestinal nephritis.
Fluid retension may occur. Chronic abuse of analgesics may cause nephropathy. Other adverse effects include anaemias, thrombocytopenia, neutropenia, consinophilia, agranulocytosis, blurred vision, changes in visual colour perception and toxic amblyopia. Abnormalities of liver function tests 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 APO-FLURBIPROFEN should be used with caution and the dosages assessed individually.
Special precautions
Care should be taken when administering the medicine to patients with asthma or who have experienced bronchospasm with other anti-inflammatory or analgesic agents.
APO-FLURBIPROFEN 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.
Patients with congestive heart failure, cirrhosis, diuretic-induced volume depletion, or renal insufficiency require local synthesis of fasodilating prostaglindins to maintain renal perfusion, and therefore these patients are at greater risk of developing renal dysfunction due to non-steroidal anti-inflammatory drug induced inhibition of renal prostaglandin synthesis.
Patients with collagen disease may be at increased risk of developing aseptic meningitis. APO-FLURBIPROFEN should be used with caution in patients with infections since symptoms such as fever and inflammation may be masked.
In view of the product's inherent potential to cause fluid retention, heart failure may be precipitated in some compromised patients.
INTERACTIONS
The effects of oral anticoagulants may be enhanced with concomitant use of flurbiprofen. The concomitant use of flurbiprofen with litium, methotrexate and cardiac glycosides may enhance the plasma concentrations of these agents.
The risk of nephrotoxicity may be increase if given with angiotensin-converting enzyme inhibitors, cyclosporin or diuretics. These may also be an increase risk of hyperkalaemia with angiotensin-converting enzyme inhibitors and potassium-sparing diuretics.
The antihypertensive effects of angiotensin-converting enzyme inhibitors, beta blockers an diuretics may be reduced.
Convulsions may occur due to an interaction with quinoloncs.
NSAIDs may enhance the effects of phenytoin and sulphonylurea antidiabetics if given concomitantly.
The risk of gastro-intestinal bleeding and ulceration associated with the use of flurbiprofen is increased when used with corticosteroids.
Laboratory tests:
Abnormalities of liver function tests have been observed.
Some NSAIDs can interfere with thyroid function tests by lowering serum thyroid hormone concentrations.

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. Treatment is symptomatic and supportive.

IDENTIFICATION
APO-FLURBIPROFEN 50 mg: White, oval, biconvex, film-coated tablets, engraved "APO" over "50" on one side, plain on the other side.
APO-FLURBIPROFEN 100 mg: Blue, oval, biconvex, film-coated tablets, engraved "APO" over "100" on one side, plain on the other side.

PRESENTATION
APO-FLURBIPROFEN 50 mg: White high density polyethylene containers containing 100, 500 or 1000 tablets. Blister packs of 100 tablets in strips of 10.
APO-FLURBIPROFEN 100 mg: White high density polyethylene containers containing 15, 50, 100, 500 or 1000 tablets. Blister packs of 100 tablets in strips of 10.

STORAGE INSTRUCTIONS
Store below 25°C, in a well-closed container.
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBER
50 mg: 32/3.1/0010
100 mg: 32/3.1/0011

NAME AND BUSINESS ADDRESS OF THE APPLICANT
APOTEX S.A.
PHARMACEUTICAL INNOVATION
Apotex SA (Pty) Ltd
Cnr. Flemming & Watt Street
Meadowdale Ext. 1

DATE OF PUBLICATION OF THIS PACKAGE INSERT
November 1996

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