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

SCHEDULING STATUS:
Unscheduled

PROPRIETARY NAME
(and dosage form):

MEDPRAMOL SYRUP

COMPOSITION:
Each 5 mL contains 120 mg paracetamol
with methylhydroxybenzoate 0,1% and propylhydroxybenzoate 0,02% as preservatives.
Alcohol 10.5% v/v.

PHARMACOLOGICAL CLASSIFICATION:
2.8 Non-narcotic analgesics, antipyretics.

PHARMACOLOGICAL ACTION:
Paracetamol has analgesic and antipyretic actions.

INDICATIONS:
For the relief of mild to moderate pain and fever.

CONTRA-INDICATIONS:
Hypersensitivity to paracetamol.

WARNINGS:
Dosages in excess of those recommended may cause severe liver damage.

DOSAGE AND DIRECTIONS FOR USE:
Children up to 1 year: 5 mL (one medicine measureful)
1 to 5 years: 5 to 10 mL (one to two medicine measuresful)
6 to 12 years: 10 to 20 mL (two to four medicine measuresful)
All dosages may be repeated 3 - 4 times a day.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side effects:
Sensitivity reactions resulting in reversible skin rash or blood disorders may occur, but these are rare.
Special precautions:
Consult your doctor if no relief is obtained with the recommended dosage. Do not use continuously for longer than ten days without consulting your doctor. Patients suffering from liver or kidney diseases should take paracetamol under medical supervision.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
In the event of overdosage consult a doctor or take the patient to the nearest hospital immediately. Specialised treatment is essential as soon as possible. The latest information regarding the treatment of overdosage can be obtained from the nearest poison centre. Symptoms of overdosage include nausea and vomiting. Liver damage which may be fatal may only appear after a few days. Kidney failure has been described following acute intoxication.

CONDITIONS OF REGISTRATION:
None

IDENTIFICATION:
Green syrup with a spearmint flavour.

PRESENTATION:
Packed into 100 mL and 2,5 litre containers.

STORAGE INSTRUCTIONS:
Store below 25°C
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
M/2.8/149

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Geo Schwulst Laboratories Limited
42 Wendell Street
Lakeview
Johannesburg
2091

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
May 1983

PSO-58-10/89
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