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Logo BRUFEN RETARD: Tablets

SCHEDULING STATUS
Schedule 3

PROPRIETARY NAME
(and dosage form)

BRUFEN RETARD: Tablets

COMPOSITION
Each film-coated tablet contains 800 mg of
Ibuprofen in a sustained release form.

PHARMACOLOGICAL CLASSIFICATION
A/3.1/Antirheumatics (Anti-inflammatory agents)

PHARMACOLOGICAL ACTION
Chemically, Ibuprofen is described as 2-(4-isobutylphenyl)propionic acid and is a non-steroidal compound, which exhibits high levels of anti-inflammatory, analgesic and antipyretic activities necessary for the effective treatment of rheumatoid arthritis and osteo-arthritis.

Specific studies confirm that BRUFEN RETARD possesses anti-inflammatory, analgesic and antipyretic properties in animal tests. Glucocorticoid activity is absent.

BRUFEN RETARD tablets are specially formulated to allow the gradual release of active substance giving stable levels and a prolonged duration of effect over the dosage interval. There is no evidence of accumulation. Two major metabolites of Ibuprofen have been isolated from human urine. They are (+)2,4 (2-hydroxy-2-methylpropyl) phenylpropionic acid (metabolite A) and (+)2,4 (2-carboxylpropyl) phenylpropionic acid (metabolite B). The rate of absorption may be delayed by food and higher plasma concentrations (Cmax) may also be obtained when taken with food.

The levels in human serum of both metabolites have been measured after single and repeated doses. About 60% of a dose is excreted in the urine, and the excretory products are in the form of either free or conjugated metabolites A and B. No Ibuprofen is found.

INDICATIONS
BRUFEN RETARD is indicated for its analgesic and anti-inflammatory effect in the treatment of rheumatoid arthritis (including juvenile rheumatoid arthritis or Still's disease), ankylosing spondylitis, and osteo-arthritis. BRUFEN RETARD is indicated in the treatment of non-articular rheumatism including fibrositis. BRUFEN RETARD is indicated in periarticular conditions such as frozen shoulder (capsulitis), bursitis, tendinitis, tenosynovitis and low-back pain. BRUFEN RETARD can also be used in soft-tissue injuries such as sprains and strains. BRUFEN RETARD is also indicated for its analgesic effect in the relief of mild to moderate pain such as dysmenorrhoea, dental, post-episiotomy pain and post-partum pain.

CONTRA-INDICATIONS
BRUFEN RETARD should not be given to patients with peptic ulceration. The safety of BRUFEN RETARD in pregnancy has not been established.

Bronchospasm may be precipitated in patients suffering from, or with a previous history of, bronchial asthma. BRUFEN RETARD should not be given to patients in whom aspirin and other non-steroidal anti-inflammatory drugs induce the symptoms of asthma, rhinitis or urticaria.

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.

DOSAGE AND DIRECTIONS FOR USE
BRUFEN RETARD is not recommended in children under 12 years.

Adults: The recommended daily dosage is two tablets taken as a single dose, preferably in the early evening. The tablets should be swallowed whole with plenty of fluid. In severe or acute conditions, the total daily dosage may be increased to three tablets taken in two divided doses.
Elderly: No special dosage modifications are required for elderly patients, unless renal or hepatic function is impaired, in which case dosage should be assessed individually.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
Dyspepsia, nausea, gastro-intestinal intolerance and bleeding may occur. Skin rashes of various types have been observed. Bronchospasm and cases of thrombocytopenia and agranulocytosis have been reported. Toxic amblyopia has occurred. Abdominal discomfort, blurred vision, depression, drowsiness, insomnia, nephrotic syndrome, other ocular reactions, peptic ulcer and pruritus may also occur.
Headache, dizziness, nervousness and other central effects, vomiting, diarrhoea, oedema and tinnitus may occur. Abnormalities of liver function tests and impairment of renal function have been observed. Acute allergic reactions have been reported.
Use with care in patients with bleeding disorders, cardiovascular disease, patients using anticoagulant medicines and in elderly patients. Acute reversible renal failure has been reported.
Use with care in patients with impaired renal function.
Use with care together with other protein-bound medicines (e.g. tolbutamide, coumarin and hydantoin).

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
The most likely symptoms of overdosage are epigastric pain and nausea. Treatment is symptomatic and supportive.

IDENTIFICATION
BRUFEN RETARD is a white, pillow-shaped, film-coated tablet containing 800 mg of Ibuprofen BP in a sustained-release form. Each tablet is overprinted 'BRUFEN RETARD' in red.

PRESENTATION
BRUFEN RETARD is packed in: Cartons containing 56 tablets in blister strips.

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

REGISTRATION NUMBER
Y/3.1/13

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
26 June 1991

                                4566

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