ASPIRIN SOLUBLE 300 mg TABLETS

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

ASPIRIN SOLUBLE 300 mg TABLETS - LENNON

SCHEDULING STATUS:
Unscheduled.

PROPRIETARY NAME
(and dosage form):

ASPIRIN SOLUBLE 300 mg TABLETS - LENNON

COMPOSITION:
Each tablet contains 300 mg Aspirin.

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

PHARMACOLOGICAL ACTION:
Aspirin has analgesic, anti-inflammatory and antipyretic actions. It inhibits the biosynthesis of prostaglandins.

INDICATIONS:
Aspirin soluble is effective for the relief of pain of mild to moderate intensity. Aspirin is indicated in a wide variety of febrile conditions.

CONTRA-INDICATIONS:
Patients with peptic ulcers, haemophilia or intolerance (hypersensitivity) to aspirin, severe renal impairment and patients receiving anti-coagulant therapy.

WARNING:
Aspirin has been implicated in Reye’s syndrome, a rare but serious illness, in children and teenagers with chickenpox and influenza. A doctor should be consulted before aspirin is used in such patients.

DOSAGE AND DIRECTIONS FOR USE:
Adults
1 - 3 tablets dissolved in water, as required. Not more than 13 tablets to be taken in any 24 hour period.

Do not use continuously for longer than ten (10) days without consulting your doctor. Not to be taken during the first and third trimesters of pregnancy except under the advice and supervision of a medical doctor. Excessive and prolonged use of this medicine may be dangerous.

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 anti-diabetic preparations and sulphonamides. Aspirin diminishes the effects of anti-gout preparations such as probenecid and sulphinpyrazone. Barbiturates and other sedatives may mask the respiratory symptoms of aspirin overdosage and have been reported to enhance its toxicity.

Prolonged uses of high doses may lead to anaemia, blood dyscrasias, gastrointestinal haemorrhage, peptic ulceration and renal papillary necrosis. The use of aspirin during the first and third trimesters of pregnancy is not advised.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
These include dizziness, tinnitus, sweating, nausea, vomiting, mental confusion, hyperventilation, fever, respiratory alkalosis, metabolic acidosis and depression of the central nervous system. In children serious signs of overdosage may develop rapidly.
In cases of overdosage, consult your doctor immediately.
Treatment is supportive and symptomatic.

IDENTIFICATION:
White flat bisected tablet with bevelled edges.

PRESENTATION:
Packs of 100 and 1000 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C.
Store in a well-closed container.
Protect from moisture.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
B/2.8/1157.

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

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

23.2.1983

M200