INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
ACU-PARACETAMOL S Syrup

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

ACU-PARACETAMOL S Syrup

COMPOSITION:
Each 5 mL contains:

Paracetamol

120 mg

Preservatives:

Methylparaben	0,10% (m/v)
Propylparaben	0,01% (m/v)

Contains no alcohol, sugar or tartrazine.

PHARMACOLOGICAL CLASSIFICATION:
A 2.7 Anti-pyretic or anti-inflammatory analgesics.

PHARMACOLOGICAL ACTION:
Paracetamol has analgesic and antipyretic actions.

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

CONTRA-INDICATIONS:
Sensitivity to paracetamol. Severe liver function impairment.

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

1.	Consult your doctor if no relief is obtained with the recommended dosage.
2.	Do not use continuously for longer than 10 days without consulting your doctor.
3.	Store in a safe place out of reach of children.
4.	Patients suffering from liver or kidney disease should take paracetamol under medical supervision.

DOSAGE AND DIRECTIONS FOR USE:

Infants	3 –12 months	:	2,5 mL
Children	1 to 4 years	:	2,5 to 5 mL
Children	5 to 8 years	:	5 mL –10 mL
Children	9 to 12 years	:	10 mL –15 mL

Repeat 3 to 4 times daily if necessary. Maximum 4 doses daily.
Do not exceed the stated dose.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Sensitivity reactions resulting in reversible skin rash or blood disorders, e.g. neutropenia, leucopenia, pancytopenia may occur.
The skin rash is usually erythematous or urticarial but sometimes more serious and may be accompanied by fever and mucosal lesions.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur.
Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias have been reported.
Symptoms during the first 2 days of acute poisoning do not reflect the potential seriousness of the overdosage. Nausea, vomiting, anorexia and abdominal pain may persist for a week or more. Liver injury may become manifest on the second day, (or later) initially by elevation of serum transaminase and lactic dehydrogenase activity, increased serum bilirubin concentration and prolongation of prothrombin time. The liver damage may progress to encephalopathy, coma and death. Cerebral oedema and nonspecific myocardial depression have also occurred.
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.
Prompt treatment is essential. Any patient who has ingested about 7,5 g of paracetamol in the preceding 4 hours should undergo gastric lavage. Specific therapy with an antidote such as acetylcysteine or methionine may be necessary. If decided         upon, acetylcysteine should be administered IV as soon as possible.
Acetylcysteine:
Acetylcysteine should be administered as soon as possible, preferably within 8 hours of overdosage.
IV: An initial dose of 150 mg/kg in 200 mL glucose injection, given intravenously over 15 minutes, followed by an intravenous infusion of 50 mg/kg in 500 mL of glucose injection over the next 4 hours and then 100 mg/kg in 1000 mL over the next 16 hours.
The volume of intravenous fluids should be modified for children.
Orally: 140 mg/kg as a 5% solution initially, followed by a 70 mg/kg solution every 4 hours for 17 doses. Acetylcysteine is effective if administered within 8 hours of overdosage.

IDENTIFICATION:
A clear red syrup with a blackberry odour and taste.

PRESENTATION:
Amber glass bottles containing 100 mL and 2,5 litre polyethylene containers.

STORAGE INSTRUCTIONS:
Store below 25°C and protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
28/2.7/0686

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
APOTEX S.A.
PHARMACEUTICAL INNOVATION
Apotex SA (Pty) Ltd
C/o Watt and Fleming Streets
Meadowdale Ext. 1.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
8 January 1996

                        P 280686/3
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