INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
EXTRA STRENGTH ANADIN® TABLETS

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

EXTRA STRENGTH ANADIN^® TABLETS

COMPOSITION:
Each tablet contains:

	Aspirin	500 mg
	Caffeine Anhydrous	32 mg

PHARMACOLOGICAL CLASSIFICATION:
A.2.8 Analgesic combinations.

PHARMACOLOGICAL ACTION:
EXTRA STRENGTH ANADIN TABLETS has analgesic anti-inflammatory and antipyretic action. It inhibits the biosynthesis of prostaglandins.

INDICATIONS:
EXTRA STRENGTH ANADIN TABLETS are effective for the relief of pain of mild to moderate intensity.
EXTRA STRENGTH ANADIN TABLETS are indicated in a wide variety of febrile conditions.

CONTRA-INDICATIONS:
Patients with peptic ulcers, hypersensitivity to Aspirin, severe renal impairment, haemophilia, dyspepsia and patients taking anticoagulants or insulin.

WARNINGS:
Do not use continuously for more than 10 days without consulting your doctor. Excessive and prolonged use of this medicine may be dangerous. The use of tablets during the first and last trimesters of pregnancy is not advised except under the supervision of a medical doctor.

Aspirin has been implicated in Reye's Syndrome, a rare but serious illness in children and teenagers, with chicken pox and influenza. A doctor should be consulted before Aspirin is used in such patients.

DOSAGE AND DIRECTIONS FOR USE:

Adults:

Take two tablets with water, repeat every four hours if necessary. Do not exceed 8 tablets in any 24 hour period.

Not recommended for children under the age of 12.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Dizziness or irritation of the gastric mucosa and resultant dyspepsia, haematemesis and melaena may occur in some cases. Some persons, especially asthmatics, exhibit notable sensitivity to Aspirin which may provoke various hypersensitivity reactions which may include skin eruptions, paroxysmal bronchospasm and dyspnoea.
It should be administered with caution to patients with impaired renal function, dyspepsia, anaemia and when the patient is dehydrated.
Aspirin may enhance the activity of coumarin anti-coagulants and oral antidiabetic preparations and sulphonamides. Aspirin diminishes the effects of anti-gout preparations such as probenecid and sulphin-pyrazone. Barbiturates and other sedatives may mask the respiratory symptoms of aspirin overdosage and have been reported to enhance its toxicity. Prolonged use of high doses may lead to anaemia, blood dyscrasias, gastro-intestinal haemorrhage, peptic ulceration, and renal papillary necrosis.
The use of Aspirin during the first and last three months of pregnancy is not advised.
Caffeine's side-effects include nausea, headaches and insomnia. Caffeine increases gastric secretions and may cause gastric ulcerations.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
"Aspirin" component:
These include dizziness, tinnitus, sweating, nausea, vomiting, mental confusion, hyperventilation, respiratory alkalosis, metabolic acidosis, ketosis and depression of the central nervous system.
In children serious signs of overdosage may develop rapidly.

"Caffeine" component:
Overdosage with Caffeine may cause symptoms of restlessness etc. scotoma, tachycardia and extrasystoles.
In cases of overdosage, consult a doctor immediately. Treatment is supportive and symptomatic.

IDENTIFICATION:
White, compressed tablets with "500" imprinted in a distinctive arrow on one side and "500" on the other side.

PRESENTATION:

Available in:	Strip packs of 72 x 2 tablets.
	Blister packs of 10 and 30 tablets.
	Securitainers of 72 tablets.

STORAGE INSTRUCTIONS:
Store protected from light in a cool, dry place (below 25 °C).
Keep container firmly sealed.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
N/2.8/176

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:
October 1980
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