INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
FLUSIN sugar coated tablets

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

FLUSIN sugar coated tablets

COMPOSITION:
Each tablet contains:

Chlorpheniramine maleate	2 mg
Ephedrine hydrochloride	6 mg
Paracetamol	200 mg
Caffeine	20 mg

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

PHARMACOLOGICAL ACTION:
FLUSIN tablets have analgesic, antipyretic, antihistaminic and decongestant properties.

INDICATION:
For the symptomatic relief of colds and influenza associated with nasal and sinus congestion.

CONTRA-INDICATIONS:

1.	Sensitivity or intolerance to any of the ingredients.
2.	Patients with coronary disease, hypertension, cardiovascular disease, hyperthyroidism, epilepsy.
3.	FLUSIN tablets are contra-indicated in patients being treated with monoamine oxidase inhibitors or within 14 days of stopping such treatment.
4.	The safety of Flusin tablets during pregnancy and lactation has not been established.
5.	Not for use in children younger than eight years of age.

WARNINGS:

1.	Do not use continuously for more than 10 days without consulting your doctor.
2.	Dosages in excess of those recommended may cause severe liver damage.
3.	Patients suffering from liver and kidney disease should take FLUSIN tablets under medical supervision. Paracetamol should also be given with care to patients taking other drugs that affect the liver.
4.	The use of this medicine may lead to drowsiness and impaired concentration which may be aggravated by the simultaneous intake of alcohol or other central nervous system depressants.

DOSAGE AND DIRECTIONS FOR USE:

1.	Adults and children over 12 years: Two tablets every 4 hours if necessary.
2.	Children (8-12 years): One tablet every 4 hours if necessary.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Ephedrine hydrochloride - fear, anxiety, restlessness, tremor, insomnia, confusion, irritability, weakness and psychotic states. Appetite may be reduced and nausea and vomiting may occur.
Vasoconstriction with resultant hypertension. The rise in blood pressure may produce cerebral haemorrhage and pulmonary oedema. There may also be a reflex bradycardia, but stimulation of B₁-adrenergic receptors of the heart may produce tachycardia and cardiac arrythmias, anginal pain, palpitations and cardiac arrest. Hypotension with dizziness and fainting and flushing may occur.
Difficulty in micturition and urinary retention, dyspnoea, altered metabolism, including disturbances of glucose metabolism, sweating and hypersalivation. Headache is also common.
Should be used with caution in patients with:
Hyperthyroidism
Cardiovascular disease such as ischaemic heart disease, arrhythmia or tachycardia (Anginal pains may be precipitated in patients with angina pectoris);
Occlusive vascular disorders, including arteriosclerosis, hypertension or aneurisms.
Diabetus mellitus;
Closed-angle glaucoma.
Should be avoided or used with caution inpatients undergoing anaesthesia with cyclopropane, halothane or other halogenated anaesthetics as they may induce ventricular fibrillation.
An increased risk of arrhythmias may occur given to patients receiving cardiac glycosides, quinidine or tricyclic antidepressants.

Chlorpheniramine maleate - may produce sedation and patients should not operate machinery, drive cars climb dangerous heights or perform potentially dangerous tasks where impaired decision making could lead to accidents. Other central nervous system depressants such as narcotic analgesics, hypnotics, sedatives and tranquillizers, if taken concomitantly, will enhance sedation. Care should be observed when tricyclic antidepressants, guanethidine, reserpine, alpha-methyldopa or atropine are taken concomitantly (an increased risk of arrhythmia may occur).²⁾
Other untoward reactions referable to central actions include dizziness, tinnitus, lassitude, incoordination, fatigue, blurred vision, diplopia, euphoria, nervousness, insomnia and tremors.
Digestive tract - loss of appetite, nausea, vomiting, epigastric distress, and constipation or diarrhoea. Their incidence may be reduced by giving the drug with meals. Other side effects include dryness of the mouth, throat and respiratory passages; urinary frequency and dysuria; palpitation; hypertension, headache; tightness of the chest; tingling, heaviness, and weakness of the hands.³⁾

Caffeine - nausea, vomiting, abdominal pain, gastro-intestinal bleeding, insomnia, headache, anxiety, restlessness, vertigo and palpitations can occur. The effects subside with rest and cessation of medication.

Paracetamol - usually mild. Though haematological reactions have been reported. FLUSIN tablets should be given with care to patients with a history of peptic ulceration.
In adults hepatotoxicity may occur after ingestion of a single dose of 10 to 15 g (200 to 250 mg/kg) of paracetamol.
Sensitivity reactions to FLUSIN tablets may include reversible skin rashes or blood disorders.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side-Effects".
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. In severe poisoning, hepatic failure may progess to encephalopathy, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias have been reported. Liver damage is likely in adults who have taken 10 g or more of paracetamol. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are employed) become irreversibly bound to liver tissue. Prompt treatment is essential in the management of paracetamol overdosage. Any patient who has ingested about 7,5 g or more of paracetamol in the preceeding 4 hours should undergo gastric lavage. Specific therapy with an antidote such as acetylcysteine or methionine may be necessary.
Ephedrine overdosage may result in convulsions and hypertension in susceptible patients.
Overdosage may also cause tachycardia arrhythmias and anginal pain, scintillating scotoma and respiratory depression. Overdosage with chlorpheniramine may be fatal especially in infants and children in whom the main symptoms are CNS stimulation and antimuscarinic effects. Deepening coma, cardiorespiratory collapse and death may occur within 18 hours. In adults, the usual symptoms are of CNS depression with drowsiness, coma, and convulsions. Hypotension may also occur.
Elderly patients are susceptible to the CNS depressant and hypotensive effects even at therapeutic doses.
Severe caffeine overdosage or idiosyncrasy may also lead to maniacal behaviour, diuresis and repeated vomiting with extreme thirst, tremor, delirium, hyperthermia, tachycardia, tachypnoea, electrolyte disturbances, convulsions, and death.
Treatment is symptomatic and supportive.
The patient maybe taken to a doctor or hospital immediately as specialized treatment may be necessary.

IDENTIFICATION:
A biconvex sugar coated orange tablet.

PRESENTATION:
Available in packs of 24, 100 and 1000.

STORAGE DIRECTIONS:
Store in a cool place, below 25°C.
Keep out of reach of children.

REFERENCE NUMBER:
C562 (Act 101/1965).

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Columbia Pharmaceuticals (Pty) Ltd
Tempelhof-South
Bonaero Park 1620

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
4 October 1993.
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