Adco-Linctopent Syrup

ADCO-LINCTOPENT SYRUP is indicated for cough associated with wheeziness (bronchospasm) and tenacious phlegm (sputum).

Posology
Adults and children over 12 years : 10 to 20 ml three times daily.
Children 3 to 12 years : 5 to 10 ml three times daily.
Children 1 to 3 years: 2,5 to 5 ml three times daily.
Infants : 2,5 ml three times daily.
DO NOT EXCEED THE RECOMMENDED DOSE.

Method of administration
For oral use only.
Shake the bottle before use

• Hypersensitivity to bromhexine hydrochloride, orciprenaline citrate or any of the other ingredients (see section 6.1)
• Thyrotoxicosis.
• Hypertrophic obstructive cardiomyopathy, and tachyarrhythmia.
• If the patient receives a monoamine oxidase inhibitor (MAOI) or within 14 days of MAOI treatment termination since sympathomimetics, such as orciprenaline sulphate, may interact with MAOIs.
• Pregnancy or breastfeeding.

Bromhexine hydrochloride:
Caution should be observed in patients with gastric ulcers due to the mucolytic action of bromhexine hydrochloride.
Care should be taken in asthmatic patients.
Clearance of bromhexine or its metabolites may be reduced in patients with severe hepatic or renal impairment.

Orciprenaline sulphate:
Other sympathomimetic bronchodilators should only be used with ADCO- LINCTOPENT SYRUP under strict medical supervision. However, anticholinergic bronchodilators may be inhaled at the same time.
Careful consideration should be given before administering ADCO- LINCTOPENT SYRUP to the elderly.
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 dysrhythmias.
Caution should be exercised in patients suffering from hyperthyroidism due to sympathomimetic effects of orciprenaline sulphate.
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, aneurysms, pheochromocytoma, prostatism, and in patients who are unusually responsive to sympathomimetic amines.
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.
This medicine contains 1750 mg sorbitol in each 5 ml which is equivalent to 0,35 g/ml.
ADCO-LINCTOPENT SYRUP contains parahydroxybenzoates which may cause allergic reactions (possibly delayed).
ADCO-LINCTOPENT SYRUP contains 250 mg propylene glycol in each 5 ml dose which is equivalent to 50 mg per ml. If your baby is less than 4 weeks old, talk to your doctor or pharmacist before giving them ADCO-LINCTOPENT SYRUP, in particular if the baby is given other medicines that contain propylene glycol or alcohol. If your child than 5 years old, talk to your doctor or pharmacist before giving them ADCO-LINCTOPENT SYRUP, in particular if they use other medicines that contain propylene glycol or alcohol.

• The concomitant use of other sympathomimetic medicines, anticholinergics, and xanthine derivatives (such as theophylline) should be carefully controlled to avoid potentiation of effects.
• A potentially serious reduction in bronchodilation may occur during concomitant administration of beta- blockers. ADCO-LINCTOPENT SYRUP should not be administered concomitantly with beta-blocking medicines, due to orciprenaline sulphate's reversal of antihypertensive action.
• 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.
• An increased risk of arrhythmias may also occur if given to patients receiving cardiac glycosides, quinidine, or tricyclic antidepressants.
• With the concomitant administration of corticosteroids and ADCO-LINCTOPENT SYRUP, the risks of hypokalaemia, hyperglycaemia, and pulmonary oedema are increased.
• 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.

Safety in pregnancy and lactation has not been established. ADCO-LINCTOPENT SYRUP may inhibit uterine contractions in pregnancy. No fertility data available.

ADCO-LINCTOPENT SYRUP may lead to drowsiness and impaired concentration that may be aggravated by the simultaneous intake of alcohol or other central nervous system depressants. Patients should be advised, particularly at the initiation of therapy, against taking charge of vehicles or machinery or performing potentially hazardous tasks where loss of concentration could lead to accidents.

a. Summary of the safety profile
The undesirable effects listed are based on the MedDRA system organ classes (SOC) classification system. The frequency groupings listed conform to the following convention: Frequent (u22651/10); common; Less frequent (u22651/1 000 to <1/100); rare (u22651/10 000 to <1/1 000); very rare (<1/10 000) and unknown (cannot be estimated from the available data).

b. Tabulated list of adverse reactions

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the Med Safety APP (X SAHPRA) found on SAHPRA website and eReporting platform (who-umc.org) found on SAHPRA website. Adverse Drug Reactions may also be reported to Adcock Ingram Limited using the following email: [email protected]

The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation with the most prominent being tachycardia, central nervous system stimulation, palpitations, tremor, hypertension, hypokalaemia, hyperglycaemia, hypotension, widening of the pulse pressure, anginal pain, arrythmias and flushing. Treatment should be symptomatic and supportive. The administration of a cardio-selective beta-adrenergic blocking agent may be necessary to effectively antagonise the bronchodilator action of orciprenaline sulphate 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. In asthmatics the use of a cardio-selective beta-blocker such as atenolol or acebutolol is preferred.