Sympomatic treatment of acute exacerbations of chronic bronchitis in adults as an expectorant.
Erdosteine is a prodrug that is metabolised into N-thiodiglycolyl-homocysteine whereby free thiol groups are formed leading to the opening of the disulphide bonds of the bronchial mucoproteins, thus reducing the viscosity of mucus and purulent sputum. It also antagonises the local formation of free radicals and inhibits elastase enzyme activity and bacterial adhesion to epithelial cells.
Oral Acute exacerbations of chronic bronchitis Adult: 300 mg bid. Max treatment duration: 10 days.
Active peptic ulcer. Severe hepatic and renal impairment (CrCl <25 mL/min). Patient with history of peptic ulcer. Mild to moderate renal and hepatic impairment. Pregnancy and lactation.
Significant: Epigastric pain, taste alteration, angioedema. Gastrointestinal disorders: Nausea, vomiting, diarrhoea. Nervous system disorders: Headache. Respiratory, thoracic and mediastinal disorders: Cold, dyspnoea. Skin and subcutaneous tissue disorders: Cutaneous hypersensitivity reactions (e.g. urticaria, erythema, eczema).
There is no experience for the use of erdosteine in pregnant women. Therefore, the use of erdosteine in pregnant or breast-feeding women is not recommended. Erdotin has minor or negligible influence on the ability to drive and use machines.
Keep in a dry place away from light and heat. Keep out of reach of children