- Approval Id
- b683455ad30d2e9d
- Drug Name
- ERDOMED DISPERSIBLE TABLETS 300MG
- Product Name
- ERDOMED DISPERSIBLE TABLETS 300MG
- Approval Number
- SIN15826P
- Approval Date
- 2019-10-02
- Registrant
- HYPHENS PHARMA PTE. LTD.
- Licence Holder
- HYPHENS PHARMA PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FOR SOLUTION
- Dosage
- <p><strong>4.2. Posology and method of administration</strong><br>
Elderly and adults above 18 years:<br>
Oral formulations:<br>
<u>Posology</u><br>
<em>300 mg hard capsules:</em> 1 capsule 2–3 times a day, for oral use.<br>
<em>300 mg dispersible tablets:</em> 1 tablet 2–3 times a day, for oral use.</p>
<p><u>Method of administration for <em>dispersible tablets</em></u><br>
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.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1. Therapeutic indications</strong><br>
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.</p>
- Contraindications
- <p><strong>4.3. Contra-indications</strong><br>
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.<br>
Patients with active peptic ulcer.<br>
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.</p>
<p><strong>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.</strong></p>
<p>The drug is contraindicated in children younger than 2 years (oral forms).</p>
- Atc Code
- R05CB15
- Atc Item Name
- erdosteine
- Pharma Manufacturer Name
- HYPHENS PHARMA PTE. LTD.
