Each hard capsule contains: Erdosteine 300 mg.
Excipients/Inactive Ingredients: Povidone, microcrystalline cellulose, magnesium stearate, gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), indigotine (E 132).
medicines for cough and cold diseases. ATC code:
ERDOMED (erdosteine) acts pharmacologically as a fluidifying agent of bronchial mucus.
Pharmacodynamics: Mechanism of action/pharmacodynamic effects:
Erdosteine, active ingredient of ERDOMED, in addition to its mucolytic properties on bronchial mucus thus facilitating expectoration, shows effects in antagonizing the local formation of free radicals and inhibiting the activity of the elastase enzyme.
Pharmacological studies have demonstrated that erdosteine does not possess these properties as such, but it is active only after metabolization. In fact, the SH groups, to which the activity is ascribed, are chemically used and become free only after metabolization or in alkaline environment. This property guarantees a good palatability with no bad taste and mercaptanic regurgitations and a good gastric tolerability.
Peak plasma concentration of the product occurs after 30-60 minutes.
Subsequent complete metabolization to similar metabolites.
Very good bioavailability by oral route.
Toxicology: Preclinical safety data:
(See Table 1.)
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Mucolytic agent for use in adults with acute and chronic respiratory disorders (including chronic obstructive pulmonary disease, acute exacerbations of chronic obstructive pulmonary disease, rhinosinusitis, pharingolaryngotracheitis, acute and chronic bronchitis) associated with excessive mucus production.
Elderly and adults above 18 years: Oral formulations: Posology: 1 capsule 2-3 times a day, for oral use.
With dosages exceeding those recommended (1200 mg/day), sweating, vertigo and flushing have been observed.
Hypersensitivity to the active substance or to any of the excipients listed in Excipients/Inactive Ingredients under Description.
Patients with active peptic ulcer.
Because of a possible interference of the product metabolites with methionine metabolism, ERDOMED is contraindicated in patients suffering from hepatic cirrhosis and deficiency of the cystathionine-synthetase enzyme.
Since there are no data in patients with renal failure with creatinine clearance < 25 ml/min or with severe liver failure, the use of erdosteine is not recommended in these patients.
The drug is contraindicated in children younger than 2 years (oral forms).
The possible presence of sulphurous odour is not sign of product alteration, but is characteristic of the active ingredient.
No data available in severe renal and hepatic impairment.
Effects on ability to drive and use machines: Erdomed has no influence on the ability to drive and use machines.
Use in Children: Mucolytics may induce bronchial obstruction in children younger than 2 years. In fact, the drainage capacity of bronchial mucus is limited in this age, due to the physiological characteristics of the respiratory tract. They are therefore not be used in children younger than 2 years (see Contraindications). No studies available for the recommended doses of erdosteine in children.
Pregnancy: The safety of erdosteine in pregnancy has not been established, therefore, as with all new drugs, its use is not recommended.
Breast-feeding: Equally, its use is not recommended during breast-feeding.
Less than 1 in 1,000 patients may experience gastrointestinal undesirable effects. (See Table 2.)
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No harmful interactions with other drugs have been reported and the product can therefore be administered together with antibiotics and bronchodilators (theophylline or beta2-mimetics, cough sedatives, etc…).
Incompatibilities: None known.
Instructions for use/handling: No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Do not store above 30°C.
Shelf-life: With sealed package: 3 years.
R05CB15 - erdosteine ; Belongs to the class of mucolytics. Used in the treatment of wet cough.
Hard cap 300 mg (size 1 hard gelatine capsules, with green cap and yellow body, containing an ivory powder) x 20's.