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

Logo PARACETACOD TABLETS

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

PARACETACOD TABLETS

COMPOSITION:
Each tablet contains:

Paracetamol                500 mg
Codeine phosphate         10 mg
Ascorbic acid         50 mg
Nipastat (Preservatove) 0,129% m/m
Contains TARTRAZINE

PHARMACOLOGICAL CLASSIFICATION:
A 2.8 Analgesic combination

PHARMACOLOGICAL ACTION:
Analgesic and antipyretic.

INDICATIONS:
Mild to moderate pain.

CONTRA-INDICATIONS:
Hypersensitivity to any of the active ingredients.
Patients taking monoamine oxidase inhibitoes or within 10 days of stopping such treatment.
Contra indicated in respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion; after operations on the biliary tract; acute alcoholism; head injuries and conditions in which intracranial pressure is raised.
It should not be given during an attack of bronchial asthma or in heart failure secondary to chronic lung disease.

WARNINGS:
Dosages of paracetamol in excess of those recommended may cause severe liver damage.
Consult your doctor if no relief is obtained with the recommended dosage.
Do not use continuously for more than ten days without consulting your doctor.
Contains tartrazine which may cause allergic type reactions (including bronchial asthma) in certain individuals. The overall incidence of tartrazine sensitivity is low it is however frequently seen in patients who also have aspirin sensitivity.

DOSAGE AND DIRECTIONS FOR USE:
Adults:                1 - 2 tablets repeated 6 hourly if necessary.
Children: 7 - 12 years: ½ - 1 tablet repeated 6 hourly if necessary.
DO NOT EXCEED THE STATED DOSE OF USE CONTINUOUSLY FOR MORE THAN TEN DAYS WIHTOUT CONSULTING YOUR DOCTOR.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Paracetamol:
Sensitivity reactions resulting in reversible skin rash or blood disorders may occur.
Patients suffering from liver or kidney disease should take paracetamol under medical supervision.
Codeine: May cause neausea, vomiting, constipation, drowsiness, confusion, dry mouth, sweating, facial flushing, vertigo, bradycardia, palpitations, orthostatic hypotension, hypothermia, restlessness, changes of mood and moisis.
Micturition may be difficult and there may be ureteric or biliary spasm. Raised intracranial pressure may occur. Reactions such as uriticaria and pruritus may occur.
Codeine should be given with caution to patients with hypothyroidism, adrenocortical insufficiency, impaired liver function, prostatic hypertrophy or shock. It should be used with caution in patients with inflammatory or obstructive bowel disorders. The dosage should be reduced in elderly and debilitated patients.
The depressants effect of codeine is enhanced by depressants of the central nervous system such as alcohol, anaesthetics, hypnotics and sedatives, and phenothiazines.
The prolonged use of high doses of codeine has produced dependance of the morphine type.
Ascorbic acid: Should be given with care to patients with hyperoxaluria.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Paracetamol:
Paracetamol overdosage symptoms include nausea and vomiting. Liver damage which may be fatal may only appear after a few days. Kidney failure has been described following acute intoxication.
Codeine phosphate overdosage symptoms include narcosis followed sometimes by a feeling of exhilaration and then convulsions.
Nausea and vomiting. Contracted pupils. Increased pulse. Respiratory depression.
Treatment: In the event of overdosage consult a doctor or take the patients to the nearest hospital immediately. Specialised treatment is essential as soon as possible. The latest information regarding the treatment of overdosage can be obtained from the nearest poison centre.

IDENTIFICATION:
Green flat quadrisected tablets measuring 12,7 mm in diameter.

PRESENTATION:
Packs of 20 in strips packs.
Packs of 100 in white Securitainers.
Packs of 500 in brown H.D.P.E. bottles.
Packs of 1000 in brown H.D.P.E. buckets.

STORAGE INSTRUCTIONS:
Store in airtight contaienrs below 30°C. Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
B/2.8/1329

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Adcock Ingram LTD
Adcock Ingram Park
17 Harrison Avenue, Bryanston Ext. 77
Private Bag X69, Bryanston
2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
23.03.1989

* Reg. T.M.

New addition to this site: May 2004
Source: Pharmaceutical Industry

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