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Logo INZA®-200 TABLETS
INZA®-400 TABLETS

SCHEDULING STATUS:
S3
S2 See indications below

PROPRIETARY NAME
(and dosage form):

INZA®-200 TABLETS
INZA®-400 TABLETS

COMPOSITION:
Each tablet contains 200 mg (400 mg)
Ibuprofen.

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

PHARMACOLOGICAL ACTION:
Ibuprofen is a phenylpropionic acid derivative. It has useful anti-inflammatory, analgesic and antipyretic activities. Its anti-inflammatory effects in rheumatoid arthritis are inferior to those of full doses of aspirin. In low dosage Ibuprofen may provide relief of pain without objective anti-inflammatory effect.
Ibuprofen is absorbed from the gastro-intestinal tract and peak concentrations in the circulation occur about 1½ hours after ingestion. Ibuprofen is extensively bound to plasma proteins and has a half-life of about 2 hours. It is rapidly excreted in the urine; about 60% of a dose is recovered in the urine as metabolites and their conjugates. It is believed that some Ibuprofen may be excreted in the faeces possibly after excretion in the bile.

INDICATIONS:
Schedule 3 Ibuprofen is used in the treatment of rheumatoid arthritis and osteo-arthritis.
Schedule 2 Emergency treatment of acute gout attacks. Treatment of post traumatic conditions, such as pain, swelling and inflammation, for a maximum period of 5 days.

CONTRA-INDICATIONS:
Impaired hepatic function, peptic ulceration or a history of such ulceration.

WARNING:
Safety in pregnancy has not been established.

DOSAGE AND DIRECTIONS FOR USE:
The recommended dose for the symptomatic treatment of rheumatoid arthritis is 900 to 1600 mg per day. The usual dose is 1,2 g daily in divided doses, reduced after 2 to 4 weeks to a maintenance dose of 200 mg three or four times daily. A suggested dose for children is 20 mg per kg body mass daily in divided doses with a maximum of 500 mg daily for those weighing less than 30 kg.
The recommended daily dose for adults should not exceed 1,2 grams and that for children up to and including the age of 12 years should not exceed 20 milligrams per kilogram of bodyweight.
Ibuprofen should be taken after food.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Ibuprofen should be given with care to patients with asthma or bronchospasm, bleeding disorders, cardiovascular disease, peptic ulceration or a history of such ulceration, renal failure, and in those who are receiving coumarin anticoagulants. Patients who are sensitive to aspirin should generally not be given Ibuprofen. Dyspepsia and nausea have been reported, and very rarely a skin rash. Increased values for serum transaminases have followed treatment with Ibuprofen. Vomiting, diarrhoea and occasionally stomatitis, melaena or gastro-intestinal haemorrhage, oedema, tinnitus, depression, drowsiness and insomnia can occur. Increased values for serum glutamic pyruvic transaminase, bilirubin and alkaline phosphatase have been reported but have often returned to normal, despite continued treatment. Thrombocytopenia, agranulocytosis and impairment of renal function has also been reported.
Headache, dizziness, nervousness and other central effects occur in some patients and alterations in hepatic function tests have been noted. Decreased visual acuity and visual-field defects have also occurred.
Acute reversible renal failure has been reported. Ibuprofen should be used with care in patients with impaired renal function.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See under “Side-effects and Special Precautions”. In cases of toxic effects treatment with the medicine must be discontinued. The stomach should be emptied and blood electrolyte balance should be maintained.

IDENTIFICATION:
200 mg A pink, film-coated shallow biconvex tablet engraved with Lennon logo (mortal and pestle) on one side only (diameter 10,5 mm).
400 mg A pink biconvex film-coated tablet with a diameter of about 12,5 mm.

PRESENTATION:
200 mg Packs of 30 and 1000 tablets.
400 mg Packs of 30 and 1000 tablets.

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

REGISTRATION NUMBERS:
200 mg L/3.1/45
400 mg L/3.1/46

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmacare Limited, 7 Fairclough Road, PORT ELIZABETH 6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
06/07/1976.         G358C
KOHLER C&P P.E.

Updated on this site: May 2000
Current: January 2004
Source: Community Pharmacy

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