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

Logo ASPIRIN TABLETS - LENNON

SCHEDULING STATUS:
Not scheduled.

PROPRIETARY NAME
(and dosage form):

ASPIRIN TABLETS - LENNON

COMPOSITION:
Each tablet contains 300 mg
Aspirin

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

PHARMACOLOGICAL ACTION:
Aspirin has analgesic, anti-pyretic and anti-inflammatory actions. Aspirin inhibits platelet aggregation by inactivation of platelet cyclo-oxygenase, the enzyme that produces the cyclic endoperoxide precursor of thromboxane A2.

INDICATIONS:
a) Aspirin is indicated for relief of mild to moderate pain such as headache, dysmenorrhoea, myalgia, arthralgia and neuralgia and/or fever.
  WARNINGS:
  If symptoms persist, consult your doctor. Do not use continuously for more than 10 days without consulting a doctor. 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 cases.
  DOSAGE AND DIRECTIONS FOR USE:
  300 - 900 mg (1 to 3 tablets) every 4 to 8 hours, up to a maximum of 12 tablets daily (per 24 hours).
b) Aspirin is also used to reduce the risk of myocardial infarction in patients who have had a previous myocardial infarction. It is also used to reduce the risk of recurrent transient ischaemic attacks or stroke in persons who have had transient ischaemia of the brain due to fibrin platelet emboli and to reduce the risk of graft occlusion following aorta coronary by-pass surgery.
  WARNINGS:
  The optimal dose for inhibition of platelet aggregation in humans is not known. Do not use aspirin for indications related to inhibition of platelet aggregation unless directed by a doctor.
  DOSAGE AND DIRECTIONS FOR USE:
  100 - 300 mg (1/3 to l tablet) to be taken every day, preferably at the same time each day.
Gastric irritation may be reduced by taking doses after food.

CONTRA-INDICATIONS:
Patients prone to dyspepsia or known to have a lesion of the gastric mucosa, patients with severe renal impairment and those receiving anti-coagulant therapy. It should not be administered to patients with haemophilia or other haemorrhagic disorders, to patients with gout, or to those with an intolerance (hypersensitivity) to aspirin. Not to be taken during the first and third trimesters of pregnancy except under the advice and supervision of a medical doctor. Mothers who are breastfeeding their infants should not take aspirin.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The most common side-effects are gastro-intestinal disturbances such as nausea, dyspepsia and vomiting. Irritation of the gastric mucosa with erosion, ulceration, haematemesis and melaena may occur. Slight blood loss may occur, usually not of clinical significance but it may, in afew patients, cause iron-deficiency anaemia during long-term therapy. Often this occult blood loss is not accompanied by dyspepsia and it is also not reduced by administration of aspirin with food. Antacids given in high doses or histamine H2- receptor antagonists may reduce the occult blood loss. Major upper gastric-intestinal bleeding occurs rarely. Some persons, especially those with asthma, chronic urticaria or chronic rhinitis exhibit notable sensitivity to aspirin which may provoke various reactions including urticaria and other skin eruptions, angioedema, rhinitis, and severe, even fatal paroxysmal bronchospasm and dyspnoea. Persons sensitive to aspirin may exhibit cross-sensitivity to other non-steroidal anti-inflammatory medicines.
Aspirin increase the bleeding time, decreases platelet adhesiveness, and, in large doses, may cause hypoprothrombinaemia. It may cause hepatotoxicity, particularly in patients with juvenile arthritis or other connective tissue disorders. Aspirin should be discontinued several days before scheduled surgical procedures. Concurrent administration of aspirin and the following medicines may result in an increase in peak plasma-salicylate concentrations: dipyridamole, metoclopramide, metoprolol and carbonic anhydrase inhibitors. Serum-salicylate concentrations may be reduced by concurrent administration of corticosteroids. Conversely, salicylate toxicity may occur if corticosteroids are withdrawn. Aspirin may enhance the activity of coumarin anticoagulants, sulphonylurea hypoglycaemic agents, methotrexate, phenytoin, and valproic acid. Aspirin diminishes the effects of uricosuric agents such as probenecid and sulphinpyrazone.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Mild chronic salicylate intoxication, or salicylism, occurs after repeated administration of large doses. Symptoms include dizziness, tinnitus, deafness, sweating, nausea and vomiting, headache, and mental confusion, and may be controlled by reducing the dosage. Symptoms of more severe intoxication or of acute poisoning following overdosage include hyperventilation, fever, restlessness, ketosis, and respiratory alkalosis and metabolic acidosis.
Depression of the central nervous system may lead to coma; cardiovascular collapse and respiratory failure may occur. In children drowsiness and metabolic acidosis commonly occur; hypoglycaemia may be severe. In acute salicylate overdosage the stomach should be emptied by gastric lavage. Salicylate remaining in the stomach may be absorbed by activated charcoal. Fluid and electrolyte management is the mainstay of treatment with the immediate aim being correction of acidosis, hyperpyrexia, hypokalaemia, and dehydration. Alkaline diuresis, haemodialysis, or haemoperfusion are effective methods of removing salicylate from the plasma.

IDENTIFICATION:
White biconvex tablets.

PRESENTATION:
Packs of 25, 100, 500 and 1000 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C in well closed container.
Protect from light and moisture. Exposure to air should be minimal
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION HUMBER:
B/2.8/628

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

DATE OF PUBLICATION:
15/08/1983                 G009B
  Tradepak P E.

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996,1997,1998