FLUSIN C SYRUP

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

FLUSIN C SYRUP

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

FLUSIN C SYRUP

COMPOSITION:
The syrup contains per 5 mL:

Chlorpheniramine maleate	2 mg
Pseudoephedrine hydrochloride	25 mg
Vitamin C	50 mg
Nipastat (preservative) (m/v)	0,14 %

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

PHARMACOLOGICAL ACTION:
Flusin C syrup has antihistaminic and decongestant properties.

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

CONTRA-INDICATIONS:

1.	Sensitivity or intolerance to any of the ingredients.
2.	Flucin C syrup is contra-indicated in patients being treated with monoamine oxidase inhibitors or within 14 days of stopping such treatment.
3.	The safety of Flusin C syrup during pregnancy and lactation has not been established.
4.	Flusin C syrup should not be administered to children under the age of 6 months.

WARNINGS:
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.	Children 6-12 months: 2,5 mL (half a medicine measure) twice daily.
2.	Children 2-5 years: 2,5-5 mL (half to one medicine measure) three times a day.
3.	Children 6-12 years: 5-10 mL (one to two medicine measures) three times a day.
4.	Adults: 10 mL (two medicine measures) four times a day.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Pseudoephedrine 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; occlusive vascular disorders, including arteriosclerosis, hypertension or aneurysms; diabetes mellitus; closed-angle glaucoma.

Anginal pains may be precipitated in patients with angina pectoris.

Should be avoided or used with caution in patients undergoing anaesthesia with cyclopropane, halothane or other halogenated anaesthetics as they may induce ventricular fibrillation.

An increased risk of arrhythmias may occur when given to patients receiving cardiac glycosides, quinidine or tricyclic antidepressants.

Aluminium hydroxide mixtures may enhance the absorption of pseudoephedrine.

Chlorpheniramine maleate: Because Flusin C syrup may produce sedation, 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 tranquilizers, if taken concomitantly, will enhance sedation. Care should be observed when tricyclic anti-depressants, guanethidine, reserpine, methyldopa or atropine are taken concomitantly.

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 may occur. By giving Flusin C syrup with meals the incidence may be reduced. Other side effects include dryness of the mouth, throat and respiratory passages; urinary frequency and dysuria; palpitation; hypotension, headache; tightness of the chest; and tingling, heaviness, and weakness of the hands.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See “SIDE-EFFECTS”.
Flusin C overdosage may result in convulsions and hypertension in susceptible patients. Overdosage may also cause tachycardia, arrhythmias and anginal pain and scintillating scotoma.
Overdosage 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 more susceptible to the CNS depressant and hypotensive effect even at therapeutic doses.

Treatment is symptomatic and supportive.
The patient must be taken to a doctor or hospital immediately as specialized treatment may be necessary.

IDENTIFICATION:
An orange, slightly opaque syrup with a distinct smell of oranges.

PRESENTATION:
Available in amber glass bottles of 100 mL, 500 mL or 2,5 litres.

STORAGE DIRECTIONS:
Store in a cool place, below 30°C.
Keep out of reach of children.

REGISTRATION NUMBER:
27/A5.8/523.

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Columbia Pharmaceuticals (Pty) Ltd
Tempelhof-South
1619 Bonaero Park

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

7 June 1993.

Britepak