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

Logo BETAGESIC Tablets

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

BETAGESIC Tablets

COMPOSITION:
Each sugar coated tablet contains:
Ibuprofen 200 mg.

PHARMACOLOGICAL CLASSIFICATION:
A 2.7 Anti-pyretic or antipyretic and anti-inflammatory analgesic.

PHARMACOLOGICAL ACTION:
Betagesic is a non-steroidal compound, with analgesic, anti-inflammaotry and anti-pyretic activities.

INDICATIONS:
Betagesic
is indicated for the relief of headache from musculo-skeletal origin, feverishness, muscular aches and pain, menstrual pain and dental pain.

CONTRA-INDICATIONS:
Betagesic
is not recommended for use by pregnant women.

WARNINGS:
Betagesic
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. Patients who are sensitive to aspirin should not be given Betagesic.

DOSAGE AND DIRECTIONS FOR USE:
Adults and children over 12 years: Initial dose 2 tablets with water, then if necessary, 1 or 2 tablets every four hours. Do not exceed 6 tablets in any 24 hours. Not to be given to children under 12 years.
If symptoms persist for more than 7 days, consult your doctor.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Dyspepsia, gastro-intestinal intolerance and bleeding may occur.
Other side-effects include nervousness, skin rash, pruritus, tinnitus, oedema, depression, drowsiness, headache, dizziness, insomnia and blurred vision and other visual field defects. Hypersensitivity reactions, abnormalities of liver function tests, impairment of renal function, agranulocytosis, and thrombocytopenia have been observed.
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 Betagesic.

IDENTIFICATION:
Pink, sugar-coated tablets

PRESENTATION:
Amber glass bottles and blister packs - 20 tablets.

STORAGE INSTRUCTIONS:
Store below 26°C.
Keep out of reach of children.

REGISTRATION NUMBER:
U/2.7/20

NAME AND BUSINESS ADDRESS OF APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue
Bryanston
Private Bag X69, Bryanston, 2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
09.12.1988

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

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