INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
BRUFEN 200        :        Tablets
BRUFEN 400        :        Tablets
BRUFEN 600        :        Tablets
BRUFEN PAEDIATRIC SUSPENSION : Liquid for oral administration

SCHEDULING STATUS

Schedule 3		When specifically intended for the treatment of inflammatory joint diseases.
Schedule 2	a.	Where the recommended daily dose for adults does not exceed 1.2 g and that for children up to and including the age of 12 years does not exceed 20 mg/kg of bodyweight.
	b.	When intended for emergency treatment of acute gout attacks.
	c.	When intended for the treatment of post traumatic conditions such as pain, swelling and inflammation, for a maximum period of 5 days.

PROPRIETARY NAME
(and dosage form)

BRUFEN 200        :        Tablets
BRUFEN 400        :        Tablets
BRUFEN 600        :        Tablets
BRUFEN PAEDIATRIC SUSPENSION : Liquid for oral administration

COMPOSITION

200 mg Tablet	:	Each sugarcoated tablet contains 200 mg ibuprofen
400 mg Tablet	:	Each sugarcoated tablet contains 400 mg ibuprofen
600 mg Tablet	:	Each filmcoated tablet contains 600 mg ibuprofen
Paediatric Suspension (100 mg/5 mL)	:	Each 5 mL of suspension contains 100 mg ibuprofen with methyl hydroxybenzoate 0,1% m/v, propyl hydroxybenzoate 0,05% m/v and sodium benzoate 0,25% m/v as preservatives.

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 anti-inflammatory, analgesic and antipyretic activities.
Brufen is well absorbed on oral administration. An oral dose taken on an empty stomach by human volunteers produced peak serum levels after three quarters of an hour. Absorption was slower and peak serum levels lower after food.
Excretion is rapid with 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 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 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, and acute gouty arthritis. Brufen is indicated in the treatment of non-articular rheumatism including fibrositis. Brufen is indicated in peri-articular conditions such as frozen shoulder (capsulitis), bursitis, tendinitis, tenosynovitis and low-back pain. Brufen can also be used in soft-tissue injuries such as sprains and strains. Brufen 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. Brufen may also be used as an antipyretic.

CONTRA-INDICATIONS
Brufen should not be given to patients with peptic ulceration. The safety of Brufen in pregnancy has not been established.
Hypersensitivity to Ibuprofen, aspirin or any other non-steroidal anti-inflammatory agent. 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
Adults: The recommended dosage of Brufen is 1200 mg daily in divided doses. Some patients can be maintained on 600 to 1200 mg daily. In severe conditions it can be advantageous to increase the dosage until the acute phase has been brought under control.
To relieve early morning stiffness, the first dose of the day can be given immediately after the patient awakes.
For the relief of mild to moderate pain the following doses are recommended:
Dysmenorrhoea - 1200 mg per day in three divided doses. In cases of dental or post-episiotomy pain an initial dose of 800 mg may be given. The total daily dose of Brufen should not exceed 2400 mg. Once the acute phase has been brought under control, it is normal practice to revert to a maintenance dosage.
Acute gout: 2400 mg daily either as 800 mg 8 hourly or 600 mg 6 hourly until the acute symptoms have been relieved. If the acute symptoms do not resolve within three days, consult a doctor.
Children: In Juvenile Rheumatoid Arthritis, the total daily dosage of Brufen is 20 mg/kg of body mass given in divided doses.
Safety in children under one year of age has not been proven.
Pain: Initial dose 5 mg/kg of bodyweight.
A second dose of 5 mg/kg may be given after 2 hours if pain is not controlled, thereafter 5 mg/kg every 4 - 6 hours. DO NOT EXCEED 20 mg/kg of bodyweight per day. If pain persists for more than 7 days, consult your doctor.
Fever: 5 mg/kg of bodyweight every 4 - 6 hours. DO NOT EXCEED 20 mg/kg of bodyweight per day. If fever persists for more than 3 days, consult your doctor.

Age	Bodyweight	Daily dosage in 5 mL spoonfuls
1 - 2 years	7 - 12 kg	2,5 mL up to 3 - 4 times daily
3 - 7 years	14 - 23 kg	2,5 - 5 mL up to 3 - 4 times daily
8 - 12 years	25 - 40 kg	10 mL up to 3 - 4 times daily

Do not give to children less than 7 kg or 1 year of age, except on the advice of your doctor.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
The most frequent side effects occurring with Ibuprofen are gastro-intestinal disturbances; reactions range from abdominal discomfort, nausea and vomiting, and abdominal pain to serious gastro-intestinal bleeding or activation of peptic ulcer.
CNS-related side effects include headache, dizziness, nervousness, tinnitus, depression, drowsiness, and insomnia. Hypersensitivity reactions may occur less frequently and include fever and rashes. Hepatotoxicity and aseptic meningitis which occur less frequently may also be hypersensitivity reactions. Ibuprofen can provoke bronchospasm in patients with asthma. Ibuprofen may cause cystitis and haematuria. They may also cause acute renal failure, interstitial nephritis, and nephrotic syndrome.
Other side effects include anaemias, thrombocytopenia, neutropenia, eosinophilia, agranulocytosis, abnormalities in liver function tests, blurred vision, changes in visual colour perception, and toxic amblyopia.
Precautions: Brufen should be given with care to the elderly, to patients with asthma or bronchospasm, bleeding disorders, cardiovascular disease, a history of peptic ulceration, and in liver or renal failure. Patients with congestive heart failure, cirrhosis, diuretic-induced volume depletion, or renal insufficiency require local synthesis of vasodilating prostaglandins to maintain renal perfusion, and therefore these patients are at greater risk of developing renal dysfunction due to NSAID-induced inhibition of renal prostaglandin synthesis.
Care is required in those who are also receiving coumarin anticoagulants. Patients who are sensitive to aspirin or other NSAIDs should generally not be given Ibuprofen.
Ibuprofen should be discontinued in patients who experience blurred or diminished vision, or changes in colour vision. Patients with collagen disease may be at increased risk of developing aseptic meningitis.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
The most likely symptoms of overdosage are epigastric pain and nausea. If recently taken, gastric lavage will remove any unabsorbed ibuprofen. Electrolytes may be corrected by intravenous infusions, if necessary. There is no specific antidote to Brufen.

IDENTIFICATION

200 mg Tablet:	A light magenta coloured sugarcoated tablet which may or may not be printed with BRUFEN in black on one side. The unprinted tablets being available to government hospitals only.
400 mg Tablet:	A light magenta coloured sugarcoated tablet which may or may not be printed with 400 BRUFEN in black on one side. The unprinted tablets being available to Government hospitals only.
600 mg Tablet:	A white, filmcoated, oblong tablet printed with BRUFEN 600 in black on one side.
Paediatric Suspension (100 mg/5 mL)	An orange coloured, orange flavoured syrupy suspension.

PRESENTATION

BRUFEN 200 mg:	SECURITAINERS containing 100 or 500 tablets. White plastic screwcap containers containing 1000 tablets.
BRUFEN 400 mg:	BLISTER PACK containing 30 tablets. SECURITAINERS containing 30, 50 or 250 tablets. White plastic bucket with lid containing 500 or 1000 tablets.
BRUFEN 600 mg:	BLISTER PACK containing 20 tablets or 100 tablets. White plastic screwcap containers containing 100 tablets. SECURITAINERS containing 20 or 250 tablets.
PAEDIATRIC SUSPENSION: (100 mg/5 mL)	100 mL or 200 mL in amber glass or polyethylene (plastic) bottles fitted with a white closure.

STORAGE INSTRUCTIONS

Tablets:	Store below 25°C.
Suspensions:	Store below 25°C. Protect against light. Shake well before use.

KEEP OUT OF THE REACH OF CHILDREN

REGISTRATION NUMBER

Brufen 200 mg Tablets:	A/3.1/727
Brufen 400 mg Tablets:	H/3.1/39
Brufen 600 mg Tablets:	R/3.1/71
Brufen Paediatric Suspension: (100 mg/5 mL)	Q/3.1/323

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.
                                989009/2

Updated on this site: March 2001
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