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

Logo FLUSIN DM SYRUP

SCHEDULING STATUS
S2

PROPRIETARY NAME
(and dosage form)

FLUSIN DM SYRUP

COMPOSITION:
The syrup contains per 5 mL:
Chlorpheniramine maleate 2 mg
Pseudoephedrine hydrochloride 25 mg
Dextromethorphan hydrobromide 7,5 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 DM syrup has antihistaminic, decongestant and cough suppressing properties.

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

CONTRA-INDICATIONS:
1. Sensitivity or intolerance to any of the ingredients.
2. Flusin DM 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 DM syrup during pregnancy and lactation has not been established.
4. Should not be administered to children under the age of 1 year.
5. Should not be used 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.
6. Should be avoided in patients undergoing anaesthesia with cyclopropane, halothane or other halogenated anaesthetics as they may induce, ventricular fibrillation.

WARNINGS:
Because FLUSIN DM 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 tranquillizers, if taken concomitantly, will enhance sedation.

DOSAGE AND DIRECTIONS FOR USE:
1. Children 1-5 years: 2,5-5 mL (half to one medicine measure) three times a day.
2 Children 6 to 12 years: 5-10 mL (one to two medicine measures) three times a day
3. 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.
Anginal pains may be precipitated in patients with angina pectoris.
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: Care should be observed when tricyclic antidepressants, guanethidine, reserpine, methyldopa or atropine are taken concomitantly, as the antimuscarinic effect may be enhanced.
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. 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.
Dextromethorphan hydrobromide: May include dizziness and gastrointestinal disturbances. Excitation, confusion, and respiratory depression may occur after overdosage.
Vitamin C: Large doses are reported to cause diarrhoea and other gastro-intestinal disturbances and are associated with the formation of renal calcium oxalate calculi. Ascorbic acid should be given with care to patients with hyperoxaluria. Tolerance may be induced with prolonged use of large doses.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See “SIDE-EFFECTS”.
FLUSIN DM syrup overdosage may result in convulsions and hypertension in susceptible patients. Overdosage may also cause tachycardia, arrhythmias and anginal pain, and scintillating scotoma and respiratory depression.
Overdosage may be fatal especially in infants and children in whom the main symptoms are central nervous system stimulation and antimuscarinic effects. Deepening coma, cardiorespiratory collapse and death may occur within 18 hours. In adults, the usual symptoms are of central nervous system depression with drowsiness, coma, and convulsions. Hypotension may also occur. Elderly patients are more susceptible to the central nervous system 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:
A light brown, opaque syrup with a butter toffee taste and aroma.

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

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

REGISTRATION NUMBER:
27/A5.8/0553.

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Columbia Pharmaceuticals (Pty) Ltd
Bardene Ext. 32
Boksburg
1459

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
23 July 1993.

                02/98
        Britepak
Updated on this site: October 1999

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