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

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

BAYER ASPIRIN PLUS C
Effervescent tablets

COMPOSITION:
400 mg aspirin(acetylsalicylic acid) and 240 mg ascorbic acidper tablet.

PHARMACOLOGICAL CLASSIFICATION:
A 2.8 Analgesic combinations.

PHARMACOLOGICAL ACTION:
Aspirin (acetylsalicylic acid) has analgesic, anti-pyretic and anti-inflammatory actions.

INDICATIONS:
For relief of mild to moderate pain and/or fever, including fever associated with colds and flu.

CONTRA-INDICATIONS:
Patients with gastric or duodenal ulcers, haemophilia, thrombocytopenia or other bleeding tendencies, or intolerance (hypersensitivity) to aspirin or other salicylates or ascorbic acid, 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.

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 and influenza. A doctor should be consulted before use in such patients.

DOSAGE AND DIRECTIONS FOR USE:
Do not remove from foil until immediately before use. The effervescent tablets should be dissolved completely in a glass of water before use.
Adults: 1 to 2 effervescent tablets. Repeat four hourly if necessary but not more than 8 tablets to be taken during any 24 hour period.
Children over 12 years of age: 1 effervescent tablet not more than four times a day, to a maximum of 4 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. Aspirin should be used with caution in patients who are hypersensitive to other anti-inflammatory agents or allergens. Aspirin should be withdrawn one week before surgery because of the possibility of increasing the bleeding times.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. This product contains sodium which may be harmful to people on a low sodium diet.
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, gastrointestinal 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
Aspirin: 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.
Ascorbic acid: Large doses may cause diarrhoea and other gastrointestinal disturbances.

IDENTIFICATION:
Round, white tablets marked with the ‘BAYER’cross, which dissolve to form a clear, colourless solution.

PRESENTATION:
Effervescent tablets in foil strips in packs of 10 or 20.

STORAGE INSTRUCTIONS:
Store below 25°C. Keep dry. Do not remove tablet from foil until immediately prior to use. Keep out of reach of children.

REGISTRATION NUMBER:
31/2.8/0473

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

DATE OF PUBLICATION OF THIS INSERT:
May 1997

BAYER = Registered trade mark of Bayer AG, Germany


                PATIENT INFORMATION LEAFLET
                BAYER ASPIRIN Plus C Effervescent Tablets
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 (acetylsalicylic acid) 400 mg and vitamin C 240 mg. The medicine also contains sodium citrate, sodium bicarbonate, citric acid, and sodium carbonate.
Use of this medicine:
BAYER ASPIRIN PLUS C may be taken for the relief of mild to moderate pain and the relief from fever, including the relief of fever or chills associated with colds and flu.
Before using this medicine:

•	Inform your doctor or pharmacist about alcohol or 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 or vitamin C.
•	Inform your doctor if you are pregnant, intend to become pregnant or if you are breast-feeding.
•	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.
•	Avoid using this product a week before you have any surgery, including dental surgery.
•	This product contains sodium which may be harmful to people on a low sodium diet.

How to take this medicine:
Do not remove from foil until immediately before use. The effervescent tablets should be dissolved completely in a glass of water before use.
Adults: 1 to 2 effervescent tablets. Repeat four hourly if necessary but not more than 8 tablets to be taken during any 24 hour period.
Children over 12 years of age: 1 effervescent tablet not more than four times a day, to a maximum of 4 tablets in 24 hours.
Do not share medicines prescribed for you with others.
Side-effects:
You may experience these side-effects initially. 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 PLUS C in their original foil strips, below 25°C in a dry place and out of reach of children. Keep dry. Return any unused or expired medicine to your doctor or pharmacist for safe disposal. Do not take BAYER ASPIRIN PLUS C effervescent tablets that smell strongly of vinegar.

Presentation: Effervescent tablets, in foil strips, in packs of 10 or 20.

Identification: Round, white tablets, marked with the ‘BAYER’cross, which dissolve to form a clear, colourless solution.

Registration number: 31/2.8/0473

Date of publication of this leaflet: May 1997

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

Bayer


Updated on this site: March 2003
Source: Pharmaceutical Industry
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