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

Logo ECOTRIN 81 mg (Enteric Coated Tablet)

SCHEDULING STATUS
Not scheduled

PROPRIETARY NAME
(and dosage form)

ECOTRIN 81 mg (Enteric Coated Tablet)

COMPOSITION
Each tablet contains
aspirin 81 mg :

PHARMACOLOGICAL CLASSIFICATION
A 2.7 Anti-pyretic or anti-pyretic and anti-inflammatory analgesics.
A 8 Medicines acting on the blood and haemopoietic system.

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

INDICATIONS
Indications related to inhibition of platelet aggregation: To reduce the risk of myocardial infarction in patients with unstable angina or in patients who have had a previous myocardial infarction. To reduce the risk of recurrent transient ischaemic attacks or stroke in men who have had transient ischaemia of the brain due to fibrin platelet emboli. To reduce the risk of graft occlusion following aorta coronary by-pass surgery.

DOSAGE AND DIRECTIONS FOR USE
Adults: One to three tablets as directed by your doctor to be taken every day, preferably at the same time each day.
Warning: The optimal dose for inhibition of platelet aggregation in humans is not known. Do not use this product for indications related to the inhibition of platelet aggregation unless directed by a doctor.
Indications related to analgesic, antipyretic and anti-inflammatory action: For the relief of mild to moderate pain and/or fever.

DOSAGE AND DIRECTIONS FOR USE
Adults
For pain and fever: 4 to 8 tablets every 4 hours, as needed with water or fruit juice.
Do not exceed 48 tablets in 24 hours.
Warning: If symptoms persist consult your doctor. Do not use continuously for more than 10 days without consulting your doctor.

CONTRA-INDICATIONS
Should not be administered to patients with haemorrhagic disorders, with gout, or those with intolerance to aspirin (especially aspirin-sensitive asthmatics). Use with caution in patients with impaired renal or hepatic function.
Aspirin should not be taken during the first and third trimesters of pregnancy and during lactation.
Aspirin should be discontinued one week before scheduled surgical procedures.
In the event of over dosage and notwithstanding the fact that the person may be asymptomatic, the nearest doctor, hospital, or Poison Control Centre must be contacted immediately.
Do not exceed the recommended daily dose.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
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 in used in such patients.
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 sylphinpyrazone.
Dizziness, erosion, ulceration, haematemesis and melaena may occur. Some persons, especially asthmatics exhibit notable sensitivity to aspirin which may provoke various hypersensitivity reactions which may include skin eruptions, urticaria, angio-edema, rhinitis, paroxysmal bronchospasm and dyspnoea. Aspirin increases the bleeding time and in large doses may cause hypoprothrombinaemia.
The most common adverse affects occurring with therapeutic doses of aspirin are gastrointestinal disturbances such as nausea dyspepsia and vomiting.
Aspirin may cause hepatotoxicity particularly in patients with juvenile arthritis and other connective tissue disorders.
It should be administered with caution to patients with impaired renal function, dyspepsia, anaemia and when the patient is dehydrated.

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

IDENTIFICATION
Convex, round, orange, coated tablet with a black curved “Ecotrin low” monogram on one side.

PRESENTATION
Ecotrin are available in containers of 50 and 100 pack sizes.

STORAGE INSTRUCTIONS
Store below 25ºC in a dry place.
Keep out of reach of children.

REGISTRATION NUMBER (OR REFERENCE NUMBER)
29/2.7/07674

NAME AND BUSINESS ADDRESS OF APPLICANT
PHARMAFRICA (PTY) LTD
33 Hulbert Road
New Centre
Johannesburg
2001

DATE OF PUBLICATION OF THIS PACKAGE INSERT
21 June 1996

Updated on this site: May 2014
Source: Pharmaceutical Industry

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