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

Logo SINUMAX® ALLERGY SINUS caplet

SCHEDULING STATUS:
Schedule 2

PROPRIETARY NAME
(and dosage form):

SINUMAX® ALLERGY SINUS caplet

COMPOSITION:
Each caplet contains
paracetamol 500 mg, pseudoephedrine hydrochloride 30 mg and chlorpheniramine maleate 2 mg.

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

PHARMACOLOGICAL ACTION
SINUMAX ALLERGY SINUS caplets has decongestant, analgesic, antipyretic and antihistaminic properties.

INDICATIONS
Short term relief of symptoms of the common cold, hayfever or other nasal allergies such as minor aches and pains, headache and fever, nasal stuffiness, runny nose, sneezing, itchy and watery eyes.

CONTRA-INDICATIONS
Hypersensitivity to any of the ingredients.
Paracetamol should not be used in patients with severe liver disease.
Do not use this product if you are being treated with monoamine oxidase inhibitors, or within two weeks of stopping treatment with these medications.
Pseudoephedrine hydrochloride should not be used in patients suffering from any of the following: heart disease (especially coronary insufficiency or arrhythmias), high blood pressure (hypertension), an overactive thyroid gland (hyperthyroidism), tumour of the adrenal gland (phaeochromocytoma), raised intraocular pressure (closed-angle glaucoma) and diabetes mellitus. Pseudoephedrine hydrochloride should be avoided in patients receiving chloroform, cyclopropane, halothane or other halogenated anaesthetics.
Pregnancy and lactation.

WARNINGS
Taking more than the recommended dose may cause severe liver damage.
Patients suffering from liver or kidney disease should take paracetamol only if instructed to do so by a doctor.
This medicine may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other agents which slow down the nervous system activity. Patients should be warned against taking charge of vehicles or machinery or performing potentially dangerous tasks where loss of concentration may lead to accidents.
Consult your doctor if no relief is obtained with the recommended dosage. Do not use continuously for longer than 10 days without consulting a doctor.

DOSAGE AND DIRECTIONS FOR USE
Do not exceed the stated dose.
Adults and children over 12 years: TWO caplets every 6 hours - 8 hours. Do not exceed 8 caplets in 24 hours.
Not recommended for children under 12 years of age.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Paracetamol may cause pancreatitis, allergic reactions in the form of a rash or blood disorders (including neutropenia, pancytopenia, leucopenia, agranulocytosis and thrombocytopenia). These should disappear on stopping the treatment. The rash usually appears as red areas or allergic wheals, and may be accompanied by fever and involvement of the mucous membranes.
The most common side-effect due to chlorpheniramine is sedation varying from slight drowsiness to deep sleep, including lassitude, dizziness, and inco-ordination. Paradoxical central nervous system stimulation may occur especially in children, with insomnia, nervousness, euphoria, irritability, tremors, and less frequently, nightmares, hallucinations, and convulsions.
Other side effects may include dry mouth; thickened respiratory tract secretions and tightness of the chest, blurred vision, urinary difficulty and retention, constipation and increased gastric reflux. In addition, gastro-intestinal disturbances may occur such as nausea, vomiting, diarrhoea or epigastric pain.
Hypersensitivity reactions may occur. Blood disorders including agranulocytosis, leucopenia, haemolytic anaemia and thrombocytopenia, have been reported. Other less frequently reported side-effects include hypotension, tinnitus, headache and paraesthesias.
Chloropheniramine should be given with care to patients with glaucoma, urinary retention, prostatic hypertrophy or pyloroduodenal obstruction. Caution is advised in patients with epilepsy and severe cardiovascular disorders.
Chlorpheniramine may enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotic, analgesics, sedatives and tranquillisers. Care should be taken when taking medicines containing tricyclic anti-depressants or atropine together.
Elderly patients are more susceptible to the central nervous system depressant and lowering of blood pressure effects even at dose quantities effective for treatment.
The warning signs of damage caused by ototoxic medicines may be masked by chlorpheniramine.
Other central nervous system depressants, such as alcohol, barbiturates, hyponotics, narcotic analgesics, sedatives and tranquillisers, if taken together will increase the chance of sedation. Be careful when taking medicines containing tricyclic anti-depressants or atropine together.
Pseudoephedrine hydrochloride may cause giddiness, headache, nausea, vomiting, sweating, thirst, rapid or irregular heart beat (tachycardia, ventricular arrhythmia), pain in front of the heart (precordial pain), palpitations, raised blood pressure (hypertension), micturition, difficulty in urination, muscular weakness, tremors, anxiety, restlessness and inability to sleep, fear, confusion, psychotic states, reduced appetite, dyspnoea, sweating, hypersalivation, altered metabolism including disturbance in glucose metabolism. Tolerance with dependence may occur after continued use.
The effects of pseudoephedrine hydrochloride are lessened by medicines containing guanethidine, reserpine, methyldopa and may be diminished or enhanced by tricyclic antidepressants. It may increase the possibility of irregular heart beat in patients taking digitalis.
Pseudoephedrine may increase blood pressure and therefore special care is advisable in patients receiving antihypertensive therapy.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Paracetamol
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
Initial symptoms in the first 24 hours are nausea, vomiting, anorexia, and abdominal pain and these may persist for a week or more. Liver injury may become apparent from 12 to 48 hours after ingestion and may manifest by metabolic acidosis, abnormalities of glucose metabolism, 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, cardiac arrythmias and non-specific myocardial depression have also occurred. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage.
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 intravenously as soon as possible. Acetylcysteine is effective if administered within 8 hours of overdosage.
Intravenously: 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 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.
Chlorpheniramine maleate
Overdosage with chlorpheniramine may be fatal especially in infants and children in whom the main symptoms are central nervous system stimulation and antimuscarinic effects, including ataxia, excitement, hallucinations, muscle tremor, convulsions, dilated pupils, dry mouth, flushed face and hyperpyrexia. Deepening coma, cardiorespiratory collapse, and death may occur within 18 hours. In adults the usual symptoms are central nervous depression with drowsiness, coma and convulsions. Hypotension may also occur.
Pseudoephedrine hydrochloride
Symptoms from pseudoephedrine hydrochloride overdose consist most often of anxiety, increased rate of heart beat and/or high blood pressure. Symptoms usually appear within 4 to 8 hours of being taken.
Treatment is symptomatic and supportive.

IDENTIFICATION
A film coated yellow flat-faced beveled-edge caplet imprinted Sinumax Allergy Sinus.

PRESENTATION
HDPE Bottles containing 20 caplets.

STORAGE INSTRUCTIONS
Store below 25°C. Protect from light.
Bottles: Keep well closed.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER
31/5.8/0555

NAME AND BUSINESS ADDRESS OF THE APPLICANT
JANSSEN-CILAG
JANSSEN PHARMACEUTICA (PTY) LTD
(Reg. No. 80/11122/07)
15th Road, HALFWAY HOUSE 1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT
13 March 1998

                                Code: 023748
                                                99E
B
                Britepak

Updated on this site: September 1999

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