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

Logo IBUMED (caplets)
SCHEDULING STATUS:
Two

PROPRIETARY NAME
(and dosage form):

IBUMED (caplets)

COMPOSITION:
Each caplet contains:
        Ibuprofen        200 mg

PHARMACOLOGICAL CLASSIFICATION.
A2.7 - Antipyretic or antipyretic and anti-inflammatory analgesics

PHARMACOLOGICAL ACTION:
Ibumed has anti-inflammatory, analgesic and antipyretic properties. Ibuprofen works at the source of the pain.

INDICATIONS:
For the relief of headache from musculoskeletal origin, dental pain, period pain, feverishness, muscular aches and pain.

CONTRA-INDICATIONS:
Not to be taken by pregnant women.

WARNINGS:
1.        Ibumed should not be given to patients with peptic ulceration, bleeding disorders, cardiovascular disease, or taking oral anticoagulants, or who are sensitive to aspirin.
2.        Should be used with caution by patients with asthma and especially by those who have developed bronchospasm with other non-steroidal agents.
3.        Do not exceed the stated dose.

DOSAGE AND DIRECTIONS FOR USE:
Adults and Children 12 years old and over:
        One or two caplets, taken with water three times daily.
        Do not exceed six caplets in 24 hours.
Not to be given to children under 12 years of age.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Nausea, gastro-intestinal intolerance and bleeding may occur. Skin rashes of various types have been observed. Bronchospasm and some cases of 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. 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:
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. Dialysis may be done as Ibuprofen is not strongly protein bound. There is no specific antidote to Ibuprofen. In case of an overdosage, consult your doctor immediately or take the patient to the nearest hospital.

IDENTIFICATION:
White, smooth, capsule-shaped tablet.

PRESENTATION:
12 and 24 caplets in blister packs per container.

STORAGE INSTRUCTIONS:
Store below 25° C
Keep out of reach of children.

REGISTRATION NUMBER:
T/2.7/193

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Group Laboratories S A (Pty) Limited
21 Wrench Road,
ISANDO 1600

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
May 1987

Group Laboratories SA (Pty) Ltd

809-2701-01        Rosside 28596

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