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

Logo ANADIN-3® TABLETS

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form)

ANADIN-3® TABLETS

COMPOSITION:
Each tablet contains:
  Paracetamol 500 mg
PRESERVATIVE:
Nipastat 0,2% m/m
PHARMACOLOGICAL CLASSIFICATION:
A 2.7 Anti-pyretic or anti-pyretic and anti-inflammatory analgesics.

PHARMACOLOGICAL ACTION:
ANADIN-3
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:
DOSAGES IN EXCESS OF THOSE RECOMMENDED MAY CAUSE SEVERE LIVER DAMAGE.
Patients suffering from liver or kidney disease should take paracetamol under medical supervision. Consult a doctor if no relief is obtained from the recommended dosage. Do not use continuously for more than 10 days without consulting a doctor.

DOSAGE AND DIRECTIONS FOR USE:
Do not exceed the stated dose.
Adults:
One or two tablets repeated every 4 to 6 hours if necessary but not more than 8 tablets to be taken in any 24 hour period.
Children 6 to 12 years:
Half to one tablet every 3 to 4 hours if necessary but not more than 4 doses to be taken in any 24 hour period.
Children under 6 years: Not recommended.

DO NOT USE CONTINUOUSLY FOR MORE THAN TEN (10) DAYS WITHOUT CONSULTING YOUR DOCTOR.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Sensitivity reactions resulting in reversible skin rash or other allergic reactions may occur. The rash is usually erythematous or urticarial but sometimes more serious and may be accompanied by fever and mucosal lesions.
The use of paracetamol has been associated with the occurrence of neutropenia, pancytopenia and leucopenia

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 your 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 preceeding 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:
White flat bisected tablet with bevelled edges debossed "A3" on one surface.

PRESENTATION:
ANADIN-3 is available in containers of 10's, 20's, 50's, 100's and 500's.

STORAGE INSTRUCTIONS:
Store in a well-closed container, protected from light, below 25 °C.
Exposure to air should be minimal.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
J/2.7/398

NAME AND BUSINESS ADDRESS OF APPLICANT:
S.A.D. SELF MEDICATION [PTY] LIMITED
(Co. Reg. No. 92/04769/07)
Robbie de Lange Road, Wilsonia, EAST LONDON 5201
P O Box 422, EAST LONDON 5200

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
May 1978

®REGISTERED TRADEMARK

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