INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
PARACETAMOL 500 mg-LENNON TABLETS

SCHEDULING STATUS:

Not Scheduled :	Pack sizes of 25 tablets or less, containing 500 mg of paracetamol per tablet.
Schedule: S1	Pack sizes of greater than 25 tablets.

PROPRIETARY NAME
(and dosage form):

PARACETAMOL 500 mg-LENNON TABLETS

COMPOSITION:
Each tablet contains:
Paracetamol 500 mg
Preservative: Nipastat 0,2 % m/m

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

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. The concentration in plasma reaches a peak in 30 to 60 minutes and the plasma half-life is about 2 hours after therapeutic doses. It is distributed into most body tissues.
It crosses the placenta and is present in breast milk.

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

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

WARNING:
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.
Store in a safe place out of the reach of children.

DOSAGE AND DIRECTIONS FOR USE:
Adults
1 to 2 tablets every 4 hours when necessary (maximum 8 tablets in 24 hours).
Children 6 - 12 years
½ to 1 tablet when necessary (maximum 4 tablets in 24 hours).
Children under 6 years
Paracetamol tablets are not recommended.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Skin rashes and other allergic reactions may 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 thrombocytopaenia, neutropaenia, pancytopaenia, leucopaenia and agranulocytosis. The dose should be reduced in renal functional impairment.
Paracetamol should also be given with care to patients taking other drugs that affect the liver such as the barbiturates.
The absorption of paracetamol may be accelerated by metoclopramide. Excretion may be affected and plasma concentrations altered when administered with probenecid.
Prolonged excessive use may cause irreversible kidney damage.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The consequences of overdosage can be extremely serious because of the narrow margin between therapeutic and toxic doses.
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. Abdominal pain may be the first indication of liver damage. 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 or more 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, preferably within 8 hours of overdosage.

Acetylcysteine:

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 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:
White, flat, bisected tablet with bevelled edges.

PRESENTATION:
Amber PVC bottles with 1000 tablets.
HDPE jars with 5000 tablets.

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

REGISTRATION NUMBER:
28/2.7/0509

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmacare Limited
7 Fairclough Road
Korsten
PORT ELIZABETH
6020

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
03/12/1993

        G498A
        KOHLER C&P P.E.

Updated on this site: November 1999
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