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Logo BRONKESE COMPOUND LINCTUS

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

BRONKESE COMPOUND LINCTUS

COMPOSITION:
Each 5 mL of the linctus contains:

Bromhexine Hydrochloride 4,00 mg
Orciprenaline Sulphate 5,00 mg
Preservatives:
Propyl Hydroxybenzoate 0,015% m/v
Sodium Methyl Hydroxybenzoate 0,050% m/v
Sucrose-free

PHARMACOLOGICAL CLASSIFICATION:
A 10.1 : Antitussives and Expectorants.

PHARMACOLOGICAL ACTION:
Bromhexine with Orciprenaline (Bronkese Compound Linctus) has mucolytic and bronchodilatory properties.

INDICATIONS:
BRONKESE Compound Linctus is indicated for cough associated with bronchospasm (wheeziness) and tenacious phlegm (sputum).

CONTRA-INDICATIONS:
Acute coronary disease and cardiac asthma. Caution should be observed in patients suffering from hyperthyroidism and/or peptic ulceration. Not to be administered concurrently with alpha and beta-blocking agents.

WARNINGS:
BRONKESE Compound Linctus should be avoided or used with caution in patients undergoing anaesthesia with cyclopropane, halothane or other halogenated anaesthetics, as it may induce ventricular fibrillation. An increased risk of arrhythmias may also occur if given to patients receiving cardiac glycosides, quinidine, or tricyclic antidepressants.
Many sympathomimetics interact with monoamine oxidase inhibitors, and should not be given to patients receiving such treatment or within 14 days of its termination.
KEEP OUT OF THE REACH OF CHILDREN

DOSAGE AND DIRECTIONS FOR USE:
Adults and children over 12 years: 10-20 mL three times a day.
Children younger than 12 years: 5-10 mL three times a day.
Infants: 2,5-5 mL three times a day.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Gastro-intestinal side-effects may occur occasionally with Bromhexine and a transient rise in serum aminotransferase value has been reported.
Orciprenaline Sulphate, a sympathomimetic may produce a wide range of adverse effects. Central effects include fear, anxiety, restlessness, tremor, insomnia, confusion, irritability, and psychotic states. Appetite may be reduced, and nausea and vomiting may occur.
Cardiac effects include vasoconstriction which may be sufficiently severe to cause gangrene or a rise in blood pressure which may produce cerebral haemorrhage and pulmonary oedema, reflex bradycardia. Stimulation of beta1-adrenergic receptors of the heart may produce tachycardia, cardiac arrhythmias, anginal pain, palpitations, and cardiac arrest; hypotension with dizziness and fainting and flushing may occur.
Other, effects that may occur include difficulty in micturition and urinary retention, dyspnoea, altered metabolism including disturbances of glucose metabolism, sweating and hypersalivation. Headache is also common.
Special Precautions: Since bromhexine may disrupt the gastric mucosal barrier, it should be given with caution to patients with gastric ulceration.
BRONKESE Compound Linctus should be used with caution in patients who may be hypersusceptible to the effects of sympathomimetic agents, particularly those with hyperthyroidism. Great care is also needed in patients with cardiovascular disease such as ischaemic heart disease; arrhythmia or tachycardia; occlusive vascular disorders, including arteriosclerosis; hypertension; or aneurysms. Anginal pain may be precipitated in patients with angina pectoris. Care is also required when given to patients with diabetes mellitus or closed-angle glaucoma.
Sympathomimetics may increase blood pressure and therefore special care is advisable in patients receiving antihypertensive therapy.
Interactions of sympathomimetics with alpha- and beta-blocking drugs may be complex. In the case of acute, rapidly worsening dyspnoea a doctor should be consulted immediately. If bronchial obstruction deteriorates it is inappropriate and possibly hazardous to simply increase the use of beta-agonists such as is contained in the form of orciprenaline in BRONKESE Compound Linctus beyond the recommended dose over extended periods of time. The use of high amounts of beta-agonists on a regular basis to control bronchial obstruction may suggest declining disease control.
In this situation, the patient's therapy plan and in particular the adequacy of anti-inflammatory therapy should be reviewed to prevent potentially life-threatening deterioration of disease control.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The symptoms are tremor, palpitations and rise in blood pressure which tend to subside within 3 hours. Cardiac arrhythmias and ventricular fibrillation may occur. Symptoms usually subside rapidly when treatment is stopped. A beta-blocker may be administered to counteract the effects of excessive doses, but it must be given with caution to asthmatics because of the risk of increasing bronchoconstriction.

IDENTIFICATION:
A clear, bright, colourless solution.

PRESENTATION:
Bottles containing 100 mL, 200 mL, 500 mL and 2,5 litres.

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

REGISTRATION NUMBER:
L/10.1/387.

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmacare Limited
7 Fairclough Road
Korsten
PORT ELIZABETH
6020

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
06 February 1996

        D357
        A&S PRINTERS

Current: September 2003
Source: Community Pharmacy

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