ERDOMED HARD CAPSULES 300MG [SIN15825P]

Product Info

ERDOMED HARD CAPSULES 300MG

[SIN15825P]

4.1. Therapeutic indications
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.

4.2. Posology and method of administration
Elderly and adults above 18 years:
Oral formulations:
Posology
300 mg hard capsules: 1 capsule 2–3 times a day, for oral use.
300 mg dispersible tablets: 1 tablet 2–3 times a day, for oral use.

Method of administration for dispersible tablets
The tablets should be dissolved in a glass of water. The dispersion should be stirred with a spoon and drunk immediately. The score-line on the tablet does not divide the tablet into equal half-doses.

4.3. Contra-indications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
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).