Χώρα: Μαλαισία
Γλώσσα: Αγγλικά
Πηγή: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Erdosteine
HYPHENS PHARMA SDN. BHD.
Erdosteine
30 Capsules; 20 Capsules
EDMOND PHARMA S.R.L
ERDOMED ® 300MG HARD CAPSULES _Consumer Medication Information Leaflet (RiMUP)_ Erdosteine 300mg Hard Capsules 1 WHAT IS IN THIS LEAFLET 1. What Erdomed ® is used for 2. How Erdomed ® works 3. Before you use Erdomed ® 4. How to use Erdomed ® 5. While you are using Erdomed ® 6. Side effects 7. Storage and disposal of Erdomed ® 8. Product description 9. Manufacturer and product registration holder 10. Date of revision 11. Serial number 1. WHAT ERDOMED® IS USED FOR Erdomed ® is used in reducing mucus thickness especially in both acute and severe respiratory disorders associated with excessive mucus production. 2. HOW ERDOMED ® WORKS Erdomed ® contains of _erdosteine_ , a mucolytic agent, which acts on the phlegm (mucus) in the respiratory tract or airways. 3. BEFORE YOU USE ERDOMED ® _When you must not use it _ DO NOT USE ERDOMED ® : - if you are hypersensitive (allergic) to erdosteine or any of the other ingredients of Erdomed ® ; - if you suffer from severe liver failure; - if you suffer from severe decreased kidney function; - if you have a stomach ulcer. _Before you start to use it _ PREGNANCY AND BREAST-FEEDING Talk to your doctor or pharmacist before using this medicine if you are pregnant, might become pregnant or are breast-feeding. The use of Erdomed ® in pregnant or breast-feeding women is not recommended. DRIVING AND USING MACHINES Erdomed ® has minor or negligible influence on the ability to drive and use machines. IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS OF ERDOMED ® Erdomed ® does not contain any ingredients which would influence the safe and effective use of the product. USE IN CHILDREN Erdomed ® is not recommended to be used in children younger than 18 years old. _Taking other medicines _ Erdomed ® does not usually interfere with other medicines. However, you should always tell your doctor or pharmacist about all medicines you are taking or planning to take, including any obtained without a prescription. 4 . HOW TO USE ERDOMED® HOW MUCH AND WHEN TO USE IT Erdomed ® is Διαβάστε το πλήρες έγγραφο
PACKAGE INSERT 1. TRADE NAME OF THE MEDICINAL PRODUCT ERDOMED ® 300 MG HARD CAPSULES Erdosteine 300 mg capsules are presented as size 1 hard gelatine capsules, with green cap and yellow body, containing an ivory powder. ERDOMED ® 300 MG DISPERSIBLE TABLETS Erdosteine 300 mg dispersible tablets are round, flat, light orange tablets with score on one side. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ERDOMED ® 300 mg hard capsules: Each hard capsule contains: Erdosteine 300 mg ERDOMED ® 300 mg dispersible tablets Each dispersible tablet contains: Erdosteine 300 mg Excipients with known effects: _Dispersible tablets: _ Lactose and sun-set yellow lake For complete list of excipients, see section. 6.1 3. PHARMACEUTICAL FORM Hard capsules Dispersible tablets 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Mucolytic agent for use in adults with acute and chronic respiratory disorders 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 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in _section 6.1. _ 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 (o Διαβάστε το πλήρες έγγραφο