Soluspirin Package Insert
SCHEDULING STATUS: Schedule 0
PROPRIETARY NAME (AND DOSAGE FORM):
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 is effective for the relief of pain of mild to moderate intensity. It is indicated in a wide variety of febrile conditions.
CONTRA INDICATIONS: Patients with peptic ulcer, haemophilia or intolerance (hypersensitivity) to aspirin, severe renal impairment and patients receiving oral anti-coagulant therapy.
WARNINGS: 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: Two tablets four hourly when necessary.
- Children 6 to 12 years: One tablet not more than four times daily.
- Children 3 to 5 years: Three quarter to one tablet not more than thrice daily.
- Children 1 to 2 years: One quarter to half a tablet not more than four times daily.
Soluspirin tablets should be dissolved in water before administration.
DO NOT USE CONTINUOUSLY FOR MORE THAN 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, 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 include skin eruption, paroxysmal bronchospasm and dyspnoea. Aspirin should be administered with caution to dehydrated patients and to patients with impaired renal function, dyspepsia, and anaemia. Aspirin may enhance the activity of coumarin anticoagulants, oral 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 use 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.
DO NOT USE CONTINUOUSLY FOR MORE THAN 10 DAYS WITHOUT CONSULTING YOUR DOCTOR.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: 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. In cases of overdosage, consult your doctor immediately. Treatment is supportive and symptomatic.
IDENTIFICATION: A flat, round, white tablet, scored on one side.
PRESENTATION: Bottles containing 25, 100 and 1000 tablets. In aluminium foil packs of 12, 14, 24, 48 and 96.
STORAGE INSTRUCTIONS: Keep container well closed out of reach of children. Exposure to air should be kept to the minimum.
REGISTRATION NUMBER: B/2.8/1482
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
71 Rochdale Road, Springfield Park, Durban, 4051.
DATE OF PUBLICATION OF THIS PACKAGE INSERT: 23-01-2001