INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
BAYER ASPIRIN CARDIO 100

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

BAYER ASPIRIN CARDIO 100
Enteric coated tablet

COMPOSITION:
100 mg Aspirin (acetylsalicylic acid) per tablet.

PHARMACOLOGICAL CLASSIFICATION:
A 8 Medicines acting on the blood and haemopoietic system.

PHARMACOLOGICAL ACTION:
BAYER^® ASPIRIN CARDIO 100 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 aortocoronary by-pass surgery.

CONTRA-INDICATIONS:
Patients with peptic or duodenal ulcers, haemophilia, thrombocytopenia or other bleeding tendencies,or intolerance (hypersensitivity) to aspirin or other salicylcates, severe renal impairment and patients receiving oral anti-coagulant therapy. Aspirin should not be taken during pregnancy and lactation, except under the advice and supervision of a medical doctor.

WARNING:
The optimal dose for inhibition of platelet aggregation in humans is not known. Do not use BAYER ASPIRIN CARDIO 100 for indications related to the inhibition of platelet aggregation unless directed by a 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 use in such patients.

DOSAGE AND DIRECTIONS FOR USE:
Adults: 100 to 300 mg to be taken every day, preferably at the same time each day.
The tablets should be swallowed whole. Do not chew, break or crush the tablets as this will destroy the protective effect of the enteric coating.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Concomitant therapy with other gastric irritants, such as non-steroidal anti-inflammatory agents may increase the risk of gastric irritation. Aspirin may increase the risk of gastrointestinal bleeding when taken simultaneously with corticosteroids or alcohol. BAYER ASPIRIN CARDIO 100 should be used with caution in patients who are hypersensitive to other anti-inflammatory agents or allergens. BAYER ASPIRIN CARDIO 100 should be withdrawn one week before surgery because of the possibility of increasing the bleeding times. Dizziness, irritation of the gastric mucosa and resultant dyspepsia, 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, angioedema, paroxysmal bronchospasm and dyspnoea.
It should be administered with caution to patients with impaired renal function, in the presence of severe liver disease, in patients with a history of gastrointestinal disorders such as peptic ulcers, ulcerative colitis and Crohn’s disease, dyspepsia, anaemia and when the patient is dehydrated.
Aspirin may enhance the activity of coumarin anti-coagulants, methotrexate, oral anti-diabetic preparations, valproic acid 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 dyscrasia, gastro-intestinal haemorrhage and peptic ulceration.
Interference with laboratory tests:
Salicylates may produce falsely increased results for blood creatinine, urate (low dose aspirin) and urea. Falsely decreased results may be obtained for blood thyroxine and urate (>4g/day aspirin) and for urinary 5-HIAA (with nitrosonapthol method). Urinary VMA (HMMA) levels may be falsely increased or decreased depending on the method of analysis.
Urinary glucose oxidase: Aspirin may cause a false negative test in the presence of glycosuria.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
These include dizziness, tinnitus, sweating, nausea, vomiting, altered glucose metabolism, mental confusion, hyperventilation, respiratory alkalosis, metabolic acidosis, ketosis, fluid and electrolyte losses. Depression of the central nervous system may lead to coma, cardiovascular collapse and respiratory failure.
In children serious signs of overdosage may develop rapidly. In cases of overdosage, consult a doctor immediately.
Gastric lavage, forced alkaline diuresis, restoration of fluid, electrolyte and acid balance, dialysis and supportive therapy may be required.

IDENTIFICATION:
White, round, coated tablets.

PRESENTATION:
100 mg tablets blister packed into packs of 30.

STORAGE INSTRUCTIONS:
Store below 25°C. Keep out of reach of children.

REGISTRATION NUMBER:
31/8/0413

NAME AND BUSINESS ADDRESS OF APPLICANT:
Bayer (Pty) Ltd. Wrench Road, Isando, 1600. 68/11192/07

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
14 August 1997

^® Bayer = Registered Trade Mark of Bayer AG, Germany

        PATIENT INFORMATION LEAFLET
        BAYER ASPIRIN CARDIO 100 Enteric Coated Tablet
Read this leaflet before you start treatment. If any of this information causes you concern or if you need more information, contact your doctor or pharmacist.
Composition:
Each tablet contains Aspirin 100 mg. The medicine also contains starch, cellulose, Eudragit L, Talc, Triethyl citrate, Hydroxypropyl Methylcellulose.
Use of this medicine:
Aspirin helps to prevent the blood from clotting. This effect is used to reduce the risk of heart attack or stroke or other problems that may occur when a blood vessel is blocked by blood clots. BAYER ASPIRIN CARDIO 100 is usually used in patients with unstable angina, in patients who have had a heart attack and in patients at risk of a stroke.
Before using this medicine:

•	Inform your doctor and pharmacist about other medicines or alcohol you are taking, especially other blood thinning agents, other pain-killers or medicines used for arthritis, sugar diabetes or gout.
•	Do not use this medicine if you are allergic to aspirin.
•	Inform your doctor if you are pregnant, intend to become pregnant or if you are breast-feeding while using this medicine.
•	Inform your doctor if you have ever had an ulcer, have a tendency to bleed, have kidney problems, diabetes, gout, asthma or other allergies.
•	Do not use aspirin in children or teenagers unless directed to do so by your doctor.
•	You may need to stop taking aspirin a week before you have any surgery done, including dental surgery. Check with your doctor if you should stop taking aspirin and when you should start taking aspirin again after you have had the surgery.

How to take this medicine:
Follow the directions for using this medicine provided by your doctor or pharmacist. Do not use BAYER ASPIRIN CARDIO 100 to prevent blood clots, heart attack or a stroke unless your doctor tells you to do so.
Take the prescribed number of tablets once a day at the same time every day. Swallow the tablets whole, with water. Do not crush, break or chew the tablets before swallowing because this will damage the enteric coating.
IF YOU MISS A DOSE OF THIS MEDICINE, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and go back to your normal dosing schedule. Do not double the dose. Do not share medicines prescribed for you with others.
Side-effects:
These possible side-effects may go away during treatment as your body adjusts to the medicine. If they continue, are severe or bother you, tell your doctor or pharmacist.

•	stomach pain or discomfort, indigestion or heartburn.
•	nausea or vomiting.

Although the following side effects are less common, if they do occur they need medical attention. Contact your doctor as soon as possible if you notice:

•	unusual bleeding or bruising
•	black stools or severe diarrhoea
•	ringing in the ears, severe headache, dizziness or drowsiness
•	confusion, changes in vision or changes in behaviour
•	excessive sweating or increased thirst.

Stop taking aspirin and contact your doctor immediately if you notice:

•	skin rash or itching
•	any difficulty in breathing
•	swelling of the eyelids, face or lips

Not all side effects reported for this medicine are included in this leaflet. If your general state of health worsens while taking this medicine, please consult your doctor.
Overdose:
In the event of an overdose or accidental ingestion, contact your doctor immediately or take the patient to the nearest hospital. In children serious signs of overdosage can develop rapidly.
Storage and disposal:
Store BAYER ASPIRIN CARDIO 100 below 25°C and out of reach of children. Return any unused or expired medicine to your doctor or pharmacist for safe disposal. Do not take BAYER ASPIRIN CARDIO 100 tablets that smell strongly of vinegar.

Bayer (Pty) Ltd, 27 Wrench Road, Isando, 1600. (Tel: - 011-921-5911)

Bayer

ZIMBABWE -Distribution Category –HR Pharmacological Classification: Drugs modifying platelet function Registration number: 99/10.5/3596

Updated on this site: March 2003
Source: Pharmaceutical Industry
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