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

Logo SUNCODIN Tablets

Aventis

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

SUNCODIN Tablets

COMPOSITION:
Per tablet:

Paracetamol         400 mg
Codeine phosphate         8 mg
Phenyltoloxamine citrate         12 mg
Caffeine         32 mg

PHARMACOLOGICAL CLASSIFICATION:
A 2.8 Analgesic combinations

PHARMACOLOGICAL ACTION:
SUNCODIN contains the analgesic and antipyretic action of paracetamol combined with the potent analgesic action of codeine phosphate. The caffeine acts on the central nervous system and produces a condition of wakefulness and increased mental activity. Phenyltoloxamine citrate is an antihistamine with the general properties of antihistamines.

INDICATIONS:
SUNCODIN is used in the treatment of muscle pain, neuralgia, pain following tooth extraction, dysmenorrhoea, sinus headaches, colds, influenza and fever.

CONTRA-INDICATIONS:
Hypersensitivity to paracetamol and codeine.
Paracetamol should be given with care to patients with impaired kidney or liver function.

WARNINGS:
Do not exceed the recommended dosage.
This medicine may lead to drowsiness and impaired concentration, which may be aggravated by the simultaneous intake of alcohol or other central nervous system depressant agents.

DOSAGE AND DIRECTIONS FOR USE:
Adults:
Two tablets three to four times daily
Children:
Under 6 years:
Not recommended
6 to 8 years: Half a tablet three times daily
9 to 12 years: One tablet four times daily.
DO NOT USE CONTINUOUSLY FOR LONGER THAN 10 (TEN) DAYS WITHOUT CONSULTING YOUR DOCTOR.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Consult your doctor if no relief is obtained with the recommended dosage. 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. In rare instances nausea has been reported following the use of codeine preparations.
Other side-effects reported include lightheadedness and drowsiness. The latter is largely overcome by the presence of caffeine in the formula.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
In the event of overdosage, consult your 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 of paracetamol can be obtained from the nearest poison centre. Symptoms of overdosage include nausea and vomiting.
Liver damage, which may be fatal, may only appear after a few days.
Overdosage with codeine can produce central stimulation, with exhilaration and in children, convulsions, followed by vomiting, drowsiness, respiratory depression, cyanosis and coma. Fatalities are, however, rare.
Kidney failure has been described following acute intoxication.
Treatment consists of:
Aspiration and lavage with 0,02% permanganate of potash solution in water.
A saline purgative such as sodium sulphate, 30 g in 250 mL of water, must be given to aid peristalsis.
If consciousness is impaired and respiration depressed, give intravenous nalorphine hydrobromide, 5 mg to 10 mg, and repeat in 15 minutes if necessary, up to a maximum of 40 mg.
Maintain circulation with infusion of plasma or suitable electrolyte solution. Assisted respiration may be necessary.

IDENTIFICATION:
Round, flat, slightly mottled yellow tablet, with bevelled edges with the word "SUNCODIN" engraved on one side.

PRESENTATION:
Tablets: 20' in blister packs and 500' in amber PVC containers

STORAGE INSTRUCTIONS:
Store below 25°C. Protect from light and air and keep well closed.
KEEP OUT OF REACH OF CHILDREN.

REFERENCE NUMBER:
B697 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Aventis Pharma (Pty) Ltd.
2 Bond Street, Midrand, 1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
2 March 1979

Aventis Pharma (Pty) Ltd
2 Bond Street
Midrand
1685

        SU2-A0003
       
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Updated on this site: December 2004
Source: Community Pharmacy

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