DOLOROL® ELIXIR

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

DOLOROL® ELIXIR

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

DOLOROL^® ELIXIR

COMPOSITION:
Each 5 mL contains:

	Paracetamol	120,00 mg
	Alcohol	9,5% v/v

Preservative:

Nipasept
in a palatable flavoured base.

0,06% m/v

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:
Severe liver function impairment.
Sensitivity to paracetamol.

WARNING:
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 in excess of those recommended 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 10 days without consulting your doctor.

DOSAGE AND DIRECTIONS FOR USE:

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 10 days without consulting your doctor. In children the 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:
Skin rashes and other allergic reactions occur occasionally. The rash is usually erythemous 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. Store in a safe place out of the reach of children.

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 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 p 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 non-specific 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 dosage 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 1 litre 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 green liquid.

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

STORAGE INSTRUCTIONS:
Store below 25°C.
Store in airtight containers.
Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
H/2.8/33

NAME AND BUSINESS ADDRESS OF APPLICANT:
Lennon Limited
7 Fairclough Road
PORT ELIZABETH
6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

30.7.1975

K281A