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

Code: 64355/ 0301

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

BAYER ASPIRIN Tablets

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

PHARMACOLOGICAL CLASSIFICATION:
A 2.7 Antipyretic and anti-inflammatory analgesics.

PHARMACOLOGICAL ACTION:
BAYER ASPIRIN has analgesic, antipyretic and anti-inflammatory actions.

INDICATIONS:
BAYER ASPIRIN is indicated for short-term use in the relief of mild to moderate pain (headache, toothache, menstrual cramps, neuralgia, muscular pain, pain associated with colds) and fever.

CONTRA-INDICATIONS:
Patients with gastric and duodenal ulcers, haemophilia, thrombocytopenia or other bleeding tendencies, intolerance (hypersensitivity) to aspirin or other salicylates, severe renal impairment or 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. Aspirin should not be taken in combination with methotrexate doses of 15 mg/week or more.

WARNINGS:
If symptoms persist, consult your doctor. Do not use continuously for more than 10 days without consulting your doctor. Aspirin has been implicated in Reye’s Syndrome, a rare but serious illness in children and teenagers with chicken pox or influenza. A doctor should be consulted before use in such patients.

DOSAGE AND DIRECTIONS FOR USE:
Adults: 1 to 3 tablets. Repeat four hourly if necessary but not more than 12 tablets to be taken during any 24 hour period.
Children over 12 years of age: 1 to 2 tablets not more than four times a day, to a maximum of 10 tablets in 24 hours.

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 should be used with caution in patients who are hypersensitive to other anti-inflammatory agents or allergens. BAYER ASPIRIN should be withdrawn one week before surgery because of the possibility of increasing the bleeding times. Some persons, especially asthmatics, those with chronic urticaria, or chronic rhinitis, exhibit notable sensitivity to aspirin which may provoke various hypersensitivity reactions which may include skin eruptions, urticaria, angioedema, paroxysmal bronchospasm and dyspnoea.
Dizziness, irritation of the gastric mucosa and resultant dyspepsia, nausea, vomiting, erosion, ulceration, haematemesis, and melaena may occur. 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:
A round white biconvex tablet with the Bayer Cross on one side and scored in quarters on the other.

PRESENTATION:
300 mg tablets in blister packs of 100, 50, 30, 10.

STORAGE INSTRUCTIONS:
Store below 25°C. Exposure to air should be minimal. Keep out of reach of children.

REGISTRATION NUMBER:
C/2.7/166

NAME AND BUSINESS ADDRESS OF APPLICANT:
Bayer (Pty) Ltd, 27 Wrench Road, Isando, 1600. 68/11192/07

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
June 1996

ZIMBABWE –HR - 98/2.2.1/3304 Pharmacological classification: 2.1 Analgesics and antipyretics

Bayer = Registered Trade Mark of Bayer AG, Germany
Code: 64355/ 0301

PATIENT INFORMATION LEAFLET

BAYER ASPIRIN Tablets 300 mg

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 300 mg. The medicine also contains starch and cellulose.
Use of this medicine:
BAYER ASPIRIN may be used for short-term use in the relief of mild to moderate pain (headache, toothache, menstrual cramps, neuralgia, muscular pain, pain associated with colds) and fever.
Before using this medicine:

•	Inform your doctor and pharmacist about alcohol or any other medicines 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.
•	Do not take aspirin a week before you have any surgery done, including dental surgery.

How to take this medicine:
Adults: One to three tablets should be taken when necessary. The dose may be repeated every four hours but do not take more than 12 tablets during any 24 hour period.
Children over the age of 12: One to two tablets. The dose may be repeated every four hours but do not take more than 10 tablets during any 24 hour period. The tablets should be taken with a full glass of water after meals or with food.
Do not use continuously for more than 10 days without consulting your doctor.
Do not remove the tablets from the blister packaging until immediately before use.
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 below 25°C and out of reach of children. Return any unused or expired medicine to your doctor, pharmacist or health care professional for safe disposal. Do not take BAYER ASPIRIN tablets that smell strongly of vinegar.

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

Updated on this site: March 2003
Source: Pharmaceutical Industry
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