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

Logo IBUMAX 200 TABLETS
IBUMAX 400 TABLETS

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 body weight.
b. When intended for emergency treatment of acute gout attack.
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):

IBUMAX 200 TABLETS
IBUMAX 400 TABLETS

COMPOSITION:
200 mg tablet: Each sugar coated tablet contains 200 mg
ibuprofen.
400 mg tablet: Each sugar coated tablet contains 400 mg ibuprofen.

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

PHARMACOLOGICAL ACTION:
Ibumax contains ibuprofen, a propionic acid derivative, which is non-steroidal compound. Ibuprofen is an anti-inflammatory agent and also has analgesic and antipyretic properties.
Ibuprofen is absorbed following oral administration, and peak serum concentrations are observed after 1 to 2 hours. The half-life in plasma is about 2 hours. Ibuprofen is extensively bound to plasma proteins (99%). It passes slowly into the synovial spaces and remains there in higher concentrations as the concentrations in plasma decline.
The excretion of ibuprofen is rapid and complete. Greater than 90% of an ingested dose is excreted in the urine as metabolites or their conjugates, and no ibuprofen by itself is found in the urine. The major metabolites are a hydroxylated and carboxylated compound.

INDICATIONS:
Ibumax is indicated in the treatment of rheumatoid arthritis (including juvenile rheumatoid arthritis or Still's disease), ankylosing spondylitis and osteoarthritis; and acute gouty arthritis, the treatment of nonarticular rheumatism, including fibrositis; the treatment of musculoskeletal pain, swelling and inflammation due to trauma. Ibumax is indicated for the relief of mild to moderate pain such as dysmenorrhoea, dental, post episiotomy and post-partum pain, headache, back pain and pain associated with migraine. Ibumax may be used as an antipyretic.

CONTRA-INDICATIONS:
Ibumax should not be administered during pregnancy and is not recommended for use by breastfeeding women. It should not be given to patients with bleeding disorders, cardiovascular disease, peptic ulceration or a history of such ulceration.
Caution is advised in those patients who are receiving coumarin anticoagulants.
Ibumax should not be given to patients who are sensitive to aspirin.
Ibumax should be prescribed with caution for those with asthma and especially for patients who have developed bronchospasm with other non-steroidal agents.

DOSAGE AND DIRECTIONS FOR USE:
Rheumatoid arthritis and osteoarthritis:
Acute:
1 200 to 2 400 mg per day in divided doses.
(6 x 200 mg tablets or 3 x 400 mg tablets up to 12 x 200 mg tablets or 6 x 400 mg tablets).
Maintenance:
600 mg to 1 200 mg per day in divided doses.

Acute gout:
2400 mg daily (800 mg 8 hourly or 600 mg 6 hourly) until acute symptoms are relieved. Consult a doctor if acute symptoms do not resolve within 3 days.

Children:
Juvenile Rheumatoid Arthritis
- 20 mg/kg of body mass in divided doses daily. Safety in children under one year of age has not been established.
Pain:
Initial dose: 5 mg/kg of body weight. After 2 hours a second dose of 5 mg/kg may be given and thereafter if pain is not controlled 5 mg/kg every 4-6 hours. Do not exceed 20 mg/kg of bodyweight per day. Consult a doctor if pain persists more than 7 days.
Fever:
5 mg/kg of body weight every 4-6 hours. Do not exceed 20 mg/kg of bodyweight per day. Consult a doctor if fever persists more than 3 days.
The tablets may be taken with food to minimise gastro-intestinal side-effects. If gastro-intestinal disturbances occur, Ibumax should be given with food or milk.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Dyspepsia, nausea, gastro-intestinal intolerance and bleeding may occur. Skin rashes of various types have been observed.
Bronchospasm, thrombocytopenia and agranulocytosis have been reported.
Toxic amblyopia has occurred.
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. 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.
The action of furosemide and the anti hypertensive effects of thiazide diuretics, beta-adrenergic antagonists, prazosin and captopril may be reduced when taken concomitantly with ibuprofen.
Acute reversible renal failure has been reported. Ibumax should be used with care in patients with impaired renal failure.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The most likely symptoms of overdosage are nausea and epigastric pain. Gastric lavage could be performed if recently taken. Further treatment is supportive and symptomatic.

IDENTIFICATION:
200 mg tablet: A pink sugar coated tablet, diameter 11,30 mm, which are printed with IBUMAX in black on one side
400 mg tablet: A pink sugar coated tablet. diameter 13, 15 mm, which are printed with IBUMAX in black on one side

PRESENTATION:
Ibumax 200: Containers of 24 and 1000 tablets
Ibumax 400: Containers of 24 and 1000 tablets

STORAGE INSTRUCTIONS:
Store below 25°C, in a dry place. Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
Ibumax 200: V/3.1/350
Ibumax 400: V/3.1/351

NAME AND BUSINESS ADDRESS OF APPLICANT:
Xeragen Laboratories (Pty) Ltd.
8-11 Glen Park, 1 Highdale Road
Glen Anil, Durban, 4051
4051

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
02/05/2003

New addition to this site: April 2004
Source: Pharmaceutical Industry

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