PARACETAMOL ELIXIR “S.A.D.”

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

PARACETAMOL ELIXIR “S.A.D.”

SCHEDULING STATUS:
Unscheduled

PROPRIETARY NAME
(and dosage form):

PARACETAMOL ELIXIR “S.A.D.”

COMPOSITION:
Each 5 mL contains:

	Paracetamol	120,00 mg
	Alcohol (96%)	10% v/v
	Preservative: Nipasept	0,06% m/v

in a palatable flavoured base. This product contains Tartrazine.

PHARMACOLOGICAL CLASSIFICATION:
A 2.8 Non-narcotic analgesics, antipyretics.

PHARMACOLOGICAL ACTION:
Paracetamol has analgesic and antipyretic effects similar to those of aspirin. However, it has no anti-inflammatory effect and does not share the antirheumatic properties of the salicylates. It is rapidly and practically completely absorbed from the gastro-intestinal tract . Plasma concentration reaches a peak in ½ to 1 hour; the plasma half-time is 1 to 3 hours.

INDICATIONS:
Paracetamol relieves pain and fever of moderate intensity.

CONTRA-INDICATIONS
Sensitivity to paracetamol.

WARNING:
Do not use continuously for more than ten (10) days without consulting your doctor.
This product contains FD and C Yellow No 5 (Tartrazine) which may cause allergic-type reactions (including Bronchial Asthma) in certain susceptible individuals. Although the overall incidence of Tartrazine sensitivity in the general population is currently thought to be low it is frequently seen in patients who also have aspirin sensitivity.

DOSAGE AND DIRECTIONS FOR USE:

Children,	3 - 12 months	½ Medicine measure (2,5 mL) in milk or water.
	1 - 5 years	1 Medicine measure (5 mL).
	6 - 12 years:	1 - 2 Medicine measures (5 - 10 mL).

The dose may be repeated every 4 hours, up to 4 times a day. Do not exceed the stated dose. Do not use continuously for more than ten (10) days without consulting your doctor. In children the daily dosage must not exceed 1,2 g (10 medicine measures) of Paracetamol and in adults the daily dosage must not exceed 4 g Paracetamol.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
In recommended therapeutic dosage, Paracetamol is usually well tolerated. Skin rashes and other allergic reactions occur occasionally. The rash is usually erythematous or urticarial but sometimes more serious and may be accompanied by drug fever and mucosal lesions. In a few cases the use of paracetamol has been associated with the occurrence of neutropenia, pancytopenia and leucopenia. The dose should be reduced in renal functional impairment. Dosage in excess of those recommend may cause severe liver damage. Patients suffering from liver or kidney disease should only take Paracetamol under medical supervision. Consult your doctor if no relief is obtained from the recommended dosage. Do not use continuously for more than ten (10) days without consulting your doctor. Store in a safe place out of reach of children.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The most serious adverse effects of acute overdosage of paracetamol is dose dependent, potentially fatal hepatic necrosis. Renal tubular necrosis arid hypoglycaemic coma may also occur. Paracetamol has caused thrombocytopenia.
Symptoms, during the first 2 days of acute poisoning do not reflect the potential seriousness of the intoxication. Nausea, vomiting, anorexia and abdominal pain occur during the initial 24 hours and may persist for a week or more. Liver injury may become manifest on the second day, initially by elevation of serum transaminase and lactic dehydrogenase activity increased serum bilirubin concentration and prolongation of prothrombin time. The hepatotoxicity may progress to encephalopathy, coma and death. Both metabolic acidosis and metabolic alkalosis have been noted; cerebral oedema and non-specific myocardial depression have also occurred. In non-fatal cases hepatic lesions are reversible over a period of weeks or months. Treatment of overdosage is purely symptomatic; vigorous supportive therapy is essential in severe intoxication. Since the hepatic injury is dose dependent and, occurs early in the course of intoxication, procedures to limit continuing absorption of the medicine must be initiated promptly. Induction of vomiting or gastric lavage should be performed in all cases and such treatment should be followed by oral administration of activated charcoal. Haemodialysis, if it can be initiated within the first 12 hours, has been advocated for all patients with a plasma acetaminophen concentration greater than 120 µg/mL 4 hours after drug ingestion. There is no known antidote for paracetamol. As little as 10 g paracetamol can lead to fatal liver necrosis in the adult, especially in the malnourished.

IDENTIFICATION:
A clear, green-coloured syrup.

PRESENTATION:
Bottles of 50 mL, 100 mL, 500 mL and 2,5 litres.

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

REGISTRATION NUMBER:
H/2.8/47.

NAME AND BUSINESS ADDRESS OF APPLICANT:
South African Druggists Ltd
7 Fairclough Road
PORT ELIZABETH
6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

13.10.75.	M77
	Len 573321 Stop Press