SINUSTAT (capsules).

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

SINUSTAT (capsules).

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

SINUSTAT (capsules).

COMPOSITION:
Each capsule contains 325 mg paracetamol and 18 mg phenylpropanolamine hydrochloride.

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

PHARMACOLOGICAL ACTION:
Sinustat has analgesic antipyretic and decongestant properties.

INDICATIONS:
Temporary relief of nasal, sinus and eustachian tube mucal congestion and associated pain and fever due to colds and influenza.

CONTRA-INDICATIONS:
Contra-indicated in patients sensitive to any of the ingredients. Should not be given to patients whose sensitivity to small doses of sympathomimetic substances is manifested by sleeplessness, dizziness, light-headedness, weakness, tremulousness or cardiac arrhythmia. Should not be given concomitantly with any monoamine-oxidase inhibitor, or within 14 days of stopping such treatment. Contra-indicated in most types of cardiovascular disease, hypertension, hyperthyroidism, hyperexcitability, phaeochromocytoma and closed-angle glaucoma.

WARNINGS:
Do not use continuously without consulting your doctor. Dosages in excess of those recommended may cause severe liver damage.

DOSAGE AND DIRECTIONS FOR USE:
Adults: Two capsules every six hours. Do not exceed six capsules in 24 hours.
Children: 6 - 12 years: One capsule every six hours. Do not exceed four capsules in 24 hours. It is not recommended for use in children under six years of age or for more than ten days usage.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Phenylpropanolamine may cause giddiness, headache, nausea, vomiting, sweating, thirst, tachycardia, precordial pain, palpitations, difficulty in micturition, muscular weakness and tremors, anxiety, restlessness and insomnia.
Hypertension and ventricular arrhythmias may occur. In patients with prostatic enlargement it may cause difficulty in micturition.
Phenylpropanolamine hydrochloride should be given with caution to patients receiving chloroform, cyclopropane, halothane or other halogenated anaesthetics. The effect of phenylpropanolamine hydrochloride are diminished by guanethidine, reserpine, methyldopa and may be diminished or enhanced by tricyclic antidepressants. It may diminish the effect of guanethidine and may increase the possibility of arrhythmias in digitalised patients.
Skin rashes and other allergic reactions may occur. The rash is usually erythematous or urticarial but sometimes more serious and may be accompanied by drug fever and mucosal lesions. The use of paracetamol has been associated with the occurrence of neutropenia, pancytopenia and leucopenia.
Prolonged use may lead to rebound congestion.
Use with caution in patients with diabetes.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms of overdosage with phenylpropanolamine hydrochloride may include rapid pulse and respiration, disorientation, elevated blood pressure, tachycardia, mydriasis, headache, excitation of the central nervous system, nausea, vomiting and anorexia. Treatment is essentially symptomatic and supportive. Immediate depletion of the stomach should be induced through emesis and gastric lavage. If marked excitation is present, one of the short-acting barbiturates or chloral hydrate may be used.
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias have been reported. Symptoms during the first two days of acute poisoning do not reflect the potential seriousness of the overdosage. Nausea, vomiting, anorexia and abdominal pain may persist for a week or more. Liver injury may manifest on the second day, (or later) initially by elevation of serum transaminase and lactic dehydrogenase activity, increased serum bilirubin concentration and prolongation of prothrombin time. The liver damage may progress to encephalopathy, coma and death. Cerebral oedema and nonspecific myocardial depression have also occurred. 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.
Prompt treatment is essential. Any patient who has ingested about 7,5 g of paracetamol in the preceding 4 hours should undergo gastric lavage. Specific therapy with an antidote such as acetylcysteine or methionine may be necessary. If decided upon, acetylcysteine should be administered IV as soon as possible.
ACETYLCYSTEINE:
Acetylcysteine should be administered as soon as possible, preferably within 8 hours of overdosage.

IV:	An initial dose of 150 mg/kg in 200 mL glucose injection, given intravenously over 15 minutes, followed by an intravenous infusion of 50 mg/kg in 500 mL of glucose injection over the next 4 hours, and then 100 mg/kg in 1000 mL over the next 16 hours. The volume of intravenous fluid should be modified for children.
Orally:	140 mg/kg as a 5% solution initially, followed by a 70 mg/kg solution every 4 hours for 17 doses. Acetylcysteine is effective if administered within 8 hours of overdosage.

IDENTIFICATION:
Standard yellow opaque and standard blue transparent hard gelatin capsule imprinted "Sinustat".

PRESENTATION:
Packages of 24 and 100 capsules.

STORAGE INSTRUCTIONS:
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
Z/5.8/360.

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
XIXIA Pharmaceuticals (Pty) Ltd
15 Thora Crescent, Wynberg Ext. 3, Sandton
P.O. Box 2080, Gallo Manor, 2052.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

23 December 1992.

P1326