Alcophyllex Syrub

Bronchospasm associated with bronchial congestion e.g., bronchial asthma, paroxysmal dyspnoea, colds, bronchitis, tracheitis, etc.

Adults: 2 to 3 medicine measures (10 to 15 mL) every four hours

Children: 2 to 6 years: u03a9 to 1 medicine measure (2,5 to 5 mL) every four hours

7 to 12 years: 1 to 2 medicine measures (5 to 10 mL) every four hours

Not for use in children under 2 years of age.

Method of administration: Oral administration only. Shake the bottle before use. Doses must be taken orally with an adequate amount of fluid (half to one glass)

• If you are hypersensitive to theophylline, hydroxyethyl theophylline (etofylline), diphenhydramine hydrochloride, ammonium chloride, sodium citrate or any of the other ingredients of ALCOPHYLLEX.
• Premature infants or neonates.
• During acute attacks of asthma.
• Patients with metabolic or respiratory alkalosis, hypocalcaemia, or hypochlorhydria.
• Impaired hepatic or renal function.
• Epilepsy
• Porphyria
• Children under the age of 2 years. (see section 4.2 Posology and method of administration)
• Concurrent use of ALCOPHYLLEX in patients taking monoamine oxidase inhibitors (MAOIs) is contraindicated (see section 4.4)
• Recent myocardial infarction. Acute tachyarrhythmia.
• Concomitant use with ephedrine in children.

A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tend to recur or is accompanied by high fever, rash or persistent headache, the patient should be advised to consult a doctor.

ALCOPHYLLEX should not be taken for persistent or chronic cough such as occurring with smoking, asthma, emphysema or where cough is accompanied by excessive phlegm (mucous).

Theophylline: Theophylline should be given with caution to patients with peptic ulceration, hyperthyroidism, hypertension, cardiac arrhythmias, or other cardiovascular diseases, as these conditions may be exacerbated. It should also be given with caution to patients with congestive heart failure, hepatic dysfunction or chronic alcoholism, acute febrile illness, severe hypoxia, cor pulmonale, acute pulmonary oedema, or other chronic lung disease, and to neonates and the elderly.

Diphenhydramine hydrochloride: Diphenhydramine hydrochloride may produce epileptiform seizures in patients with focal lesions of the cerebral cortex. Because of its antimuscarinic properties diphenhydramine hydrochloride should be used with care in conditions such as narrow angle glaucoma, urinary retention, and prostatic hypertrophy. The use of high doses of diphenhydramine-containing medicines, such as ALCOPHYLLEX, may lead to serious heart problems, seizures, coma and death.

Sodium citrate: Sodium citrate should be administered with caution to patients with congestive heart failure, renal impairment, cirrhosis of the liver, or hypertension, and to patients receiving corticosteroids.

Excipient warnings

• Contains sucrose. Patients with rare hereditary conditions such as fructose intolerance, glucose-galactose mal-absorption or sucrose-isomaltase insufficiency should not take ALCOPHYLLEX.
• This medicine contains 0,021 mg of alcohol (ethanol) in each 5 mL which is equivalent to 0,5 % v/v. The small amount of alcohol in this medicine will not have any noticeable effects.
• This medicine contains 50 mg sodium per 5 mL of syrup equivalent to 10 mg/mL of syrup. This is equivalent to 0,5 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.

Elderly: Elderly patients are more susceptible to the central nervous system depressant and hypotensive effects. The elderly are particularly prone to dizziness, sedation, confusion, hypotension and anticholinergic effects.

There is some evidence that theophylline exhibits dose-dependent kinetics, at least in sick and elderly patients. Care should be exercised by titration of dosage requirements in small increments and by monitoring serum theophylline levels.

Paediatrics: May cause excitability especially in children. ALCOPHYLLEX is unsuitable for children suffering from diabetes mellitus.

Theophylline:

• The bronchodilator and toxic effects of theophylline and sympathomimetics or other xanthines are additive. Concomitant use with other xanthine medications should be avoided.
• Interaction with allopurinol, cimetidine, propranolol, erythromycin and some other macrolides, disulfiram, fluvoxamine, interferon alfa, tetracycline, quinolones, oral contraceptives, caffeine, verapamil, zileuton, tacrine, thiabendazole, viloxazine, BCG vaccination and influenza vaccination may result in decreased hepatic theophylline clearance and increased serum half-life.
• Phenytoin and some other anticonvulsants, ritonavir, rifampicin, sulfinpyrazone, and cigarette smoking may increase theophylline clearance.
• ALCOPHYLLEX can potentiate hypokalaemia associated with the use of beta 2 agonists, corticosteroids, and diuretics.
• There is a risk of synergistic toxicity if ALCOPHYLLEX is given with halothane or ketamine.
• ALCOPHYLLEX may antagonise the effects of adenosine and of competitive neuromuscular blockers.
• ALCOPHYLLEX may enhance the elimination of lithium.
• Isoniazid impairs the elimination of ALCOPHYLLEX.

Diphenhydramine:

• Monoamine oxidase inhibitors may enhance the antimuscarinic effects of antihistamines and antihistamines have an additive anti-muscarinic action with other antimuscarinic drugs such as atropine and tricyclic antidepressants.
• The sedative effects of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives, and tranquilisers may be enhanced.
• ALCOPHYLLEX could mask the warning signs of damage caused by ototoxic drugs such as aminoglycoside antibacterials.
• Antihistamines may suppress positive skin test results and should be stopped several days before the tests.

Sodium citrate:

• ALCOPHYLLEX can enhance the absorption of aluminium from the gastrointestinal tract.

Interactions with Laboratory tests: None known

Taking ALCOPHYLLEX with food, drink and alcohol: ALCOPHYLLEX should be taken with food to minimise possible side effects. Xanthine containing beverages (e.g.: tea, coffee, cocoa) may interfere with some serum theophylline assays.

Safety and/or efficacy during pregnancy and lactation has not been established. Theophylline and diphenhydramine cross the placenta and are distributed into breast milk.

The use of this medicine 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 warned not to drive a motor vehicle, operate dangerous machinery, or climb dangerous heights, as impaired decision making could lead to accidents.

Theophylline:

Side effects are related to theophylline plasma levels: nausea and vomiting, excitation, nervousness and insomnia occur at plasma concentrations of 20 to 30 mg/L, hysteria at 30 mg/L, cardiac dysrhythmias and coma at concentrations greater than 40 mg/L. These toxic phenomena are enhanced by hypoxia and acidosis. The treatment of toxic effects is symptomatic: (whether or not temporary) discontinuance of the administration of theophylline, correction of the acidosis and hypoxia, and careful supervision of any therapeutic intervention that may aggravate underlying heart or lung diseases, such as overloading with water and salt, oxygen, sedatives, anti-emetics and beta blockers.

Diphenhydramine hydrochloride:

Ammonium chloride:

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. Healthcare providers are asked to report any suspected adverse reactions to SAHPRA via the the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. Adverse Drug Reactions may also report to Adcock Ingram Limited using the following email: [email protected].

Theophylline: Common clinical manifestations of theophylline toxicity after overdose include nausea, vomiting, diarrhoea, agitation, tremor, hypertonicity, hyperventilation, supraventricular and ventricular dysrhythmias, hypotension, and seizures. Metabolic disturbances such as hypokalaemia, hyperglycaemia, hypophosphataemia, hypercalcaemia, metabolic acidosis, and respiratory alkalosis often occur. Other toxic effects reported include dementia, toxic psychosis, symptoms of acute pancreatitis, rhabdomyolysis with associated renal failure, and acute compartment syndrome. Serious toxic symptoms may not be preceded by minor symptoms. After theophylline overdosage, elimination may be enhanced by repeated oral doses of activated charcoal. An osmotic laxative may also be considered. Treatment is symptomatic and supportive.

Diphenhydramine hydrochloride: Overdose may be fatal especially in infants and children in whom the main symptoms are CNS stimulation and antimuscarinic effects, including ataxia, excitement, hallucinations, muscle tremor, convulsions, dilated pupils, dry mouth, flushed face and hyperpyrexia. Deepening coma, cardiorespiratory collapse and death may occur. In adults, the usual symptoms are CNS depression with drowsiness, coma and convulsions. Hypertension may occur. Elderly patients are more susceptible to the CNS depressant and hypotensive effects even at therapeutic levels.

Ammonium chloride: See section 4.8

Sodium citrate: Excessive doses may lead to metabolic alkalosis, especially in patients with impaired renal function. Symptoms may include shortness of breath, muscle weakness, and mental disturbances such as restlessness, convulsions, and coma. Treatment is symptomatic and supportive.