PYRADOL

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

PYRADOL

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

PYRADOL

COMPOSITION:
Each 5 mL syrup contains:

Paracetamol	120 mg
Preservative: Nipasept	0,1% m/v
Alcohol	9,6% v/v

PHARMACOLOGICAL CLASSIFICATION:
A.2.7 Antipyretic or antipyretic and anti-inflammatory analgesics.

PHARMACOLOGICAL ACTION:
Paracetamol has analgesic and antipyretic actions.

INDICATIONS:
For the symptomatic relief of mild to moderate pain, and fever in children.

CONTRA-INDICATIONS:
Hypersensitivity to paracetamol.

DOSAGE AND DIRECTIONS FOR USE:
(Note: 1 medicine measure = 5 mL)

Infants	(3 months to 1 year)	: 2,5 mL (60 mg) 3 - 4 times daily.
Children	(1 - 3 years)	: 2,5 - 5 mL (60 -120 mg) 3 - 4 times daily.
	(3 - 6 years)	: 5 mL (120 mg) 3 - 4 times daily.
	(6 - 12 years)	: 10 mL (240 mg) 3 - 4 times daily.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
WARNING:
Dosages in excess of those recommended may cause severe liver damage.

Special precautions:

(1)	Consult your doctor if no relief is obtained with the recommended dosage.
(2)	Do not use continuously for longer than ten 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.

Side-effects:
Sensitivity reactions resulting in reversible skin rash or blood disorders may occur.

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.

IDENTIFICATION:
A clear, green liquid having a peppermint odour and taste.

PRESENTATION:
Bottles of 50 mL or 100 mL and polyethylene cans of 2,5 litres.

STORAGE INSTRUCTIONS:
Store below 25°C in tightly closed containers, protected from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
T/2.7/39

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
XIXIA Pharmaceuticals (Pty) Ltd
15 Thora Crescent
Wynberg Ext. 3
Sandton
P.O. Box 2080, Gallo Manor, 2052

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

27-8-1991

P1340