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

Logo SUNCODIN TABLETS

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 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 per cent permanganate of potash solution in water.
A saline purgative such as sodium sulphate, 30 g in 250 mL 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
Hoechst Marion Roussel Ltd
16th Road, Midrand

DATE OF PUBLICATION OF THIS PACKAGE INSERT
2 March 1979


DS 114/15
Pro-Print

Updated on this site: June 2003
Source: Community Pharmacy

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2000