(and dosage form):
Each tablet contains 500 mg paracetamol and 30 mg pseudoephedrine hydrochloride.
A 5.8 Preparations for the common cold including nasal decongestants and antihistaminics.
SINUMAX has antipyretic, analgesic and sympathomimetic properties.
For the symptomatic relief of nasal, sinus and Eustachian tube mucal congestion and associated pain and fever due to colds and influenza.
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.
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.
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.
Light green tablets with 'SINUMAX' on one side.
Bottles containing 20 tablets.
Store below 25°C. Protect from light and exposure to air. Keep out of reach of children.
NAME AND BUSINESS ADDRESS OF THE APPLICANT
JANSSEN - CILAG
Janssen Pharmaceutica (Pty) Ltd
(Reg. No. 80/11122/07)
© JANSSEN PHARMACEUTICA (PTY) LTD
DATE OF PUBLICATION OF THIS PACKAGE INSERT
11 January 1988
Code No.: 023740
Updated on this Site: September 1999
Current: May 2005
Source: Pharmaceutical Industry
SAEPI HOME PAGE
TRADE NAME INDEX
GENERIC NAME INDEX
Information presented by Malahyde Information Systems © Copyright 1996-2005