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

Logo SINUMAX® tablets

SCHEDULING STATUS:
Schedule 2

PROPRIETARY NAME
(and dosage form):

SINUMAX® tablets

COMPOSITION
Each tablet contains 500 mg
paracetamol and 30 mg pseudoephedrine hydrochloride.

PHARMACOLOGICAL CLASSIFICATION
A 5.8 Preparations for the common cold including nasal decongestants and antihistaminics.

PHARMACOLOGICAL ACTION
SINUMAX has antipyretic, analgesic and sympathomimetic properties.

INDICATIONS
For the symptomatic relief of nasal, sinus and Eustachian tube mucal congestion and associated pain and fever due to colds and influenza.

CONTRA-INDICATIONS
It is contra-indicated in persons under treatment with monoamine oxidase inhibitors, or within two weeks of stopping treatment. It should not be used by persons with a hypersensitivity to paracetamol.
Contra-indicated in most types of cardiovascular disease, hypertension, hyperthyroidism, hyperexcitability, phaeochromocytoma and closed-angle glaucoma.

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

DOSAGE AND DIRECTIONS FOR USE
Adults (and children over 12 years):
Two tablets every four to six hours. Do not exceed eight tablets in 24 hours.
Children 6 to 12 years: A half to one tablet every six hours. Do not exceed four tablets in 24 hours.
Do not use continuously for longer than 10 days without consulting your doctor.
Not recommended for children under 6 years.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
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.
Sensitivity reactions resulting in reversible skin rash or blood disorders may occur.
Haemolysis may occur in patients with glucose-6-phosphate dehydrogenase deficiency.
Pseudoephedrine hydrochloride may cause giddiness, headache, nausea, vomiting, sweating, thirst, tachycardia, precordial pain, palpitations, difficulty in micturition, muscular weakness, tremors, anxiety, restlessness and insomnia. Hypertension and ventricular arrhythmias may occur. Prolonged administration has no cumulative effect, but tolerance with dependence may occur.
Pseudoephedrine hydrochloride should be given with caution to patients with organic heart disease, cardiac decompensation or angina of effort. In patients with prostatic enlargement it may increase difficulty in micturition.

Interactions
Alcohol and drugs that induce liver enzymes can increase the hepatotoxicity of paracetamol.
Pseudoephedrine hydrochloride should be given with caution to patients receiving chloroform, cyclopropane, halothane or other halogenated anaesthetics.
The effects of pseudoephedrine hydrochloride are diminished by guanethidine, reserpine, methyldopa and may be diminished or enhanced by tricyclic antidepressants. It may diminish the effects of guanethidine and may increase the possibility of arrhythmias in digitalised patients.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
See 'Side-effects and special precautions.' Symptoms of pseudoephedrine hydrochloride overdosage include paranoid psychosis, delusions and hallucinations.
In the event of paracetamol 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 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.

IDENTIFICATION
Light green tablets with 'SINUMAX' on one side.

PRESENTATION
Bottles containing 20 tablets.

STORAGE INSTRUCTIONS
Store below 25°C. Protect from light and exposure to air. Keep out of reach of children.

REGISTRATION NUMBER
U/5.8/88

NAME AND BUSINESS ADDRESS OF THE APPLICANT
JANSSEN - CILAG
Janssen Pharmaceutica (Pty) Ltd
(Reg. No. 80/11122/07)
15th Road,
Halfway House,
1685

© JANSSEN PHARMACEUTICA (PTY) LTD

DATE OF PUBLICATION OF THIS PACKAGE INSERT
11 January 1988
        Code No.: 023740
                99E
                Britepak
                05/99

Updated on this Site: September 1999
Current: May 2005
Source: Pharmaceutical Industry

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