(and dosage form):
Each 5 mL contains:
Bromhexine hydrochloride 4 mg; orciprenaline sulphate 5 mg.
Methyl parahydroxybenzoate 0,05% m/v, propyl parahydroxybenzoate 0,01% m/v.
Alcohol free. Sugar free.
A.10.1 Medicines acting on the respiratory system. Anti-tussives and expectorants.
ADCO-LINCTOPENT SYRUP has mucolytic and bronchodilatory properties.
ADCO-LINCTOPENT SYRUP is indicated for cough associated with wheeziness (bronchospasm) and tenacious phlegm (sputum).
ADCO-LINCTOPENT SYRUP is contra-indicated in patients with known hypersensitivity to sympathomimetic amines or any of the other ingredients; hypertrophic obstructive cardiomyopathy; and tachyarrhythmia.
Sympathomimetics, such as orciprenaline sulphate, may interact with monoamine oxidase inhibitors (MAOI), and therefore ADCO-LINCTOPENT SYRUP should not be given to patients receiving such treatment or within 14 days of MAOI treatment termination.
Safety in pregnancy and lactation has not been established.
DOSAGE AND DIRECTIONS FOR USE:
Adults and children over 12 years: 10 - 20 mL three times daily.
Children 3 to 12 years: 5 - 10 mL three times daily.
Children 1 to 3 years: 2,5 - 5 mL three times daily.
Infants: 2,5 mL three times daily.
Do not exceed the recommended dose.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Bromhexine's pharmacological action may lead to gastric irritation. A transient rise in serum aminotransferase values have been reported due to bromhexine.
Orciprenaline sulphate, as a sympathomimetic agent, may precipitate a wide range of adverse effects. Side-effects include fear; anxiety, restlessness, tremor , insomnia, confusion, irritability, weakness and psychotic states. Appetite may be reduced and nausea and vomiting may occur. A rise in blood pressure which may produce cerebral haemorrhage and pulmonary oedema, tachycardia and 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; weakness; headache; disturbances of glucose metabolism; sweating and hypersalivation. Muscle cramps or twitching or unpleasant taste may occur.
ADCO-LINCTOPENT SYRUP 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.
Hypokalaemia may be induced by higher than recommended doses of beta-agonists, especially in patients receiving digitalis glycosides or diuretics or are prone to cardiac dysrrhythmias.
Caution should be exercised in patients suffering from hyperthyroidism due to sympathomimetic effects of orciprenaline sulphate.
Caution should be observed in patients with gastric ulcer due to the bromhexine hydrochloride mucolytic action.
In addition, care should be observed in patients suffering from cardiovascular diseases i.e. ischaemic heart disease; arrhythmias or tachycardia; occlusive vascular disorders including arteriosclerosis, hypertension or aneurysms. Anginal pain may be precipitated in patients suffering from angina pectoris.
Care is also required when ADCO-LINCTOPENT SYRUP is given to patients with diabetes mellitus or closed angle glaucoma.
Caution is also needed in patients with convulsive disorders.
A reduction in dose of cardiac glycosides (e.g. digitalis) and quinidine might become necessary in patients suffering from congestive cardiac failure because of the positive inotropic effect of orciprenaline sulphate.
ADCO-LINCTOPENT SYRUP should not be administered concomitantly with beta-blocking agents, due to orciprenaline's reversal of anti-hypertensive action.
The concomitant use of other sympathomimetic agents should be carefully controlled to avoid potentiation of effects.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Excessive dosage can lead to palpitations, tremor and hypotension.
Treatment should be symptomatic and supportive.
In the case of excessive dosages having been taken, gastric lavage should be considered. The administration of a cardio-selective beta adrenergic blocking agent may be necessary to effectively antagonise the bronchodilatory action of orciprenaline and for the management of cardiac arrhythmias. However, beta-blocker administration should be used with caution because it could induce severe bronchospasm or an asthma attack.
A clear colourless to pale yellow strawberry flavoured syrup.
Glass bottles of 100 mL and 200 mL.
Store below 25°C. in well-closed containers. Protect from light. Keep out of reach of children.
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
ADCOCK INGRAM LIMITED
Adcock Ingram Park
17 Harrison Avenue, Bryanston, Ext 77
Private Bag X69, Bryanston 2021
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
6 September 1996
Updated on this site: October 2005
Source: Community Pharmacy
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