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

Logo SUPRAGESIC CAPSULES

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

SUPRAGESIC CAPSULES

COMPOSITION:
Each capsule contains:
Paracetamol         350 mg
Codeine phosphate         8 mg
Caffeine         50 mg
Meprobamate         150 mg

PHARMACOLOGICAL CLASSIFICATION:
2.9 Other analgesics

PHARMACOLOGICAL ACTION:
Paracetamol has analgesic and antipyretic actions.
Codeine phosphate is an analgesic with a mild hypnotic action and is often used in combination with antipyretics and with other analgesics.
Meprobamate has tranquillising properties.

INDICATIONS:
Supragesic Capsules are recommended as an analgesic for the relief of various types of pain viz post-operative pain, dysmenorrhoea, rheumatic pain, headache, etc.

CONTRA-INDICATIONS:
History of a previous hypersensitivity reaction to meprobamate or paracetamol.

WARNING:
Do not use Supragesic Capsules continuously for more than 10 days without consulting your doctor. Consult your doctor if no relief is obtained with the recommended dosage. Patients suffering from liver or kidney disease should take paracetamol under medical supervision. Dosages in excess of those recommended may cause severe liver damage. Exceeding the prescribed dose, together with prolonged and continuous use of this medication, may lead to dependency and addiction.

DOSAGE AND DIRECTIONS FOR USE:
Adult dose: 2 capsules three times a day or as prescribed.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Paracetamol: Sensitivity reactions resulting in reversible skin rash or blood disorders may occur, but these are rare.
Codeine may produce nausea, dizziness, vomiting, mental clouding, dysphoria, constipation and increased pressure in the biliary tract but rarely on the suggested dosage of Supragesic. Increased sensitivity to pain after the analgesic effect of codeine has worn off is a common occurrence. Therefore, whilst pain is present continuous medication is advisable. Very rarely urticaria and other skin rashes may occur.
Codeine must be used with caution in any situation in which there is decreased respiratory reserve such as emphysema, kyphoscoliosis, chronic cor. pulmonale, or even severe obesity. The depressant actions of codeine are exaggerated and prolonged by phenothiazines, monoamine oxidase inhibitors and imipramine-like drugs. Large doses produce dizziness, drowsiness, ataxia, fainting, hypotension, coma, convulsions and muscular flaccidity.
Some patients show an idiosyncrasy to meprobamate, the symptoms of which are erythematous rashes with pruritis, cutaneous petechiae, peripheral oedema, arthralgia, anorexia, bronchospasm, nausea, vomiting, diarrhoea, headache, chills and fever.
It is most important that patients receiving meprobamate be warned that their tolerance to ingested alcohol may be lowered with consequent impairment of judgement and co-ordination.
Caffeine may cause unpleasant side-effects such as nausea, vomiting, headache, restlessness, palpitations, vertigo, anxiety, excitement, insomnia, sensory disturbances, muscle tremor, and diuresis. However, it is doubtful whether these symptoms will occur with the small percentage present in this preparation.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS 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. Symptoms of overdosage 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 overdosage produces central stimulation with exhilaration and, in children, convulsions, followed by vomiting, drowsiness, respiratory depression and cyanosis, and coma.
Acute poisoning with meprobamate produces stupor, coma, convulsions, shock and circulatory and respiratory collapse.

CONDITIONS OF REGISTRATION:
Advertising to the professions only.

IDENTIFICATION:
Hard gelatin capsule Size 0, Cap black, body green, imprinted with the word “Supragesic”.

PRESENTATION:
20 capsules, sample pack of 10 capsules.

STORAGE INSTRUCTIONS:
Store below 25°C in a dry place.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
F/2.9/141

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmaceutical Enterprises (Pty) Ltd
Howard Studios, Howard Drive, Pinelands, 7405

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
October 1993

Current: March 2004
Source: Pharmaceutical Industry

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