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

Logo SINUMAX® PED syrup

SCHEDULING STATUS:
Schedule 2

PROPRIETARY NAME
(and dosage form):

SINUMAX® PED syrup

COMPOSITION:
Each 5 mL contains
paracetamol 160 mg and pseudoephedrine hydrochloride 15 mg.
Preservatives: Benzoic acid 0,05% m/v and sodium benzoate 0,15% m/v.

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

PHARMACOLOGICAL ACTION
SINUMAX PED has antipyretic, analgesic and decongestant properties.

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

CONTRA-INDICATIONS
Hypersensitivity to any of the ingredients.
It is contra-indicated in persons under treatment with monoamine oxidase inhibitors, or within two weeks of stopping treatment.
Paracetamol should not be used in patients with severe liver disease.
Contra-indicated in most types of cardiovascular disease, hypertension, hyperthyroidism, hyperexcitability, phaeochromocytoma and closed-angle glaucoma.
Pregnancy and lactation.
Pseudoephedrine should be avoided in patients receiving chloroform, cyclopropane, halothane or other halogenated anaesthetics.

WARNINGS
Dosages in excess of those recommended may cause severe liver damage. Patients suffering from liver or kidney disease should take paracetamol under medical supervision.
Consult your doctor if no relief is obtained with the recommended dosage.
Do not use continuously for longer than 10 days without consulting your doctor.

DOSAGE AND DIRECTIONS FOR USE
The following doses may be repeated every 4 –6 hours as needed.
Do not exceed 4 doses in 24 hours.
Always follow the chart for proper dosing. If you have any questions, consult your doctor or pharmacist.
        AGE         DOSAGE
        (mL)
        DOSAGE
        (Medicine measure)
6 months - 2 years*         2,5 mL         ½
        2-5 years         5,0 mL         1
        6-12 years         10,0 mL         2
12 years and over         20,0 mL         4
* A physician's advice should be obtained before giving SINUMAX PED to children under 2 years.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
Paracetamol may cause pancreatitis, skin rashes and other allergic reactions. The rash is usually erythematous or urticarial but sometimes more serious and may be accompanied by fever and mucosal lesions. The use of paracetamol has been associated with the occurrence of neutropenia, pancytopenia, leucopenia, thrombocytopenia and agranulocytosis.
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, and urinary retention, dyspnoea, altered metabolism including disturbances in glucose metabolism, hypersalivation, muscular weakness and tremors. Other effects include central nervous system (CNS) stimulation such as: anxiety, restlessness and insomnia. Hypertension and ventricular arrhythmias may occur. Prolonged administration has no cumulative effect, but tolerance with dependence may occur. Appetite may be reduced.
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.
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, or patients receiving quinidine.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
If more than the recommended dose has been taken speak to your doctor or take the patient to the nearest hospital immediately.
For additional emergency information, call your nearest poison centre.
At first (during the first 24 hours), a patient who has taken a large overdose of this medicine may be pale and nauseous, and begin to vomit, have a lack of appetite, and stomach pain. Symptoms during the first two days of severe poisoning do not reflect the potential seriousness of the overdosage. Liver, kidney or heart damage may all result from paracetamol overdose. Specialised treatment is essential as soon as possible.
Information for the doctor
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 2 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 become 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 fluids 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.
Symptoms of pseudoephedrine hydrochloride overdosage include paranoid psychosis, delusions and hallucinations. Treatment is symptomatic and supportive.

IDENTIFICATION
A clear, purple syrup with a grape odour.

PRESENTATION
Glass bottles containing 30 mL or 100 mL of syrup.

STORAGE INSTRUCTIONS
Store below 25°C. Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER
30/5.8/0419

NAME AND BUSINESS ADDRESS OF THE APPLICANT
JANSSEN-CILAG logo
JANSSEN PHARMACEUTICA (PTY) LTD
(Reg. No. 1980/011122/07)
15th ROAD, HALFWAY HOUSE 1685
www.janssencilag.co.za

DATE OF PUBLICATION OF THIS PACKAGE INSERT
7 January 1997

        Code No.: 024270
        2003E
        Pro-Print
® = TRADEMARK

Updated on this site: April 2004
Current: May 2005
Source: Pharmaceutical Industry

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