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

Logo NAPACOD TABLETS
SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

NAPACOD TABLETS

COMPOSITION:
Each tablet contains.
Paracetamol                        500 mg
Codeine phosphate         10 mg
Nipastat         0.185% m/m as preservative

PHARMACOLOGICAL CLASSIFICATION
A 2.8 Central nervous system depressants. Combination analgesics.

PHARMACOLOGICAL ACTION
Analgesic and antipyretic.

INDICATIONS
For the relief of mild to moderate pain and fever.

CONTRA-INDICATIONS
Hypersensitivity to any of the active ingredients.
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.
Patients taking monamine oxidase inhibitors or within 14 days of stopping such treatment.

WARNING
Dosages of paracetamol in excess of those recommended may cause severe liver damage.

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
Children under 6 years: Not recommended
DO NOT EXCEED THE STATED DOSE. DO NOT USE CONTINUOUSLY FOR LONGER THAN 10 DAYS WITHOUT CONSULTING YOUR DOCTOR.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Side-effects
Paracetamol
Sensitivity reactions resulting in reversible skin rash or blood disorders may occur but these are rare.
May cause constipation and may delay the absorption of other medicines administered concomitantly.
Consult your doctor if no relief is obtained with the recommended dosage. Do not use continuously for longer than ten days without consulting your doctor. Store in a safe place, out of reach of children. Patients suffering from liver or kidney disease should take paracetamol under medical supervision.
Codeine phosphate
Codeine may cause nausea, vomiting, constipation, drowsiness, confusion, dry mouth, sweating, facial flushing, vertigo, bradycardia, palpitations, orthostatic hypotension, hypothermia, restlessness, changes of mood and miosis. Micturition may be difficult and there may be ureteric or biliary spasm. Raised intracranial pressure may occur. Reactions such as urticaria 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 depressant effects of codeine are 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 dependence.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
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 patient 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
Pink, flat, round, bevelled edge, bisected tablets measuring ½" (12,7 mm) in diameter.

PRESENTATION
Packs of 20,100,1 000 and 5 000.

STORAGE INSTRUCTIONS
Store in airtight containers. Protect from light. Keep out of reach of children.

REGISTRATION NUMBER
B/2.8/1401

NAME AND BUSINESS ADDRESS OF THE APPLICANT
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Ave
Bryanston
Private Bag X69, Bryanston, 2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT
15/11/1969

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

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