Erdomed 225 mg x 20 sachets Angelini

ERDOMED powder for oral solution 225 mg * 20
Patient information leaflet
ERDOMED 225 mg powder or oral solutionERDOMED 225 mg powder or oral solution
erdosteine
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

Keep this leaflet. You may need to read it again.
If you need further information or advice, ask your pharmacist.
If you get any side effects, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
If you do not feel better after 7 days or your condition worsens, you should seek medical attention.

What this leaflet contains:
1. What Erdomed is and what it is used for 2. What you need to know before you take Erdomed 3. How to take Erdomed 4. Possible side effects 5. How to store Erdomed 6. Contents of the pack and other information
1. What Erdomed is and what it is used for
Erdomed is a mucolytic and is used to liquefy secretions in acute and chronic diseases of the respiratory system. It reduces the viscosity of bronchial secretions, which facilitates expectoration. It is indicated for the treatment of:

acute diseases of the respiratory system accompanied by excessive secretion, such as: bronchitis, rhinitis, sinusitis, laryngopharyngitis;
in exacerbation of symptoms in chronic bronchitis and chronic obstructive pulmonary disease (COPD), in addition to antibiotic therapy.

2. What you need to know before you take Erdomed
Do not take Erdomed:

if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
if you suffer from liver cirrhosis or cystathionine synthetase enzyme deficiency;
if you suffer from a congenital disease of amino acid metabolism and in particular if you need to follow a methionine-free diet;
if you have severe kidney failure (creatinine clearance < 25 ml/min). Warnings and precautions: Talk to your doctor or pharmacist before taking Erdomed. Children and adolescents: Do not give Erdomed 225 mg to children under 12 years of age. Other medicines and Erdomed: You should tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Erdomed should not be used at the same time as cough suppressants, as this may cause mucus to build up in the bronchial tree. Erdomed can be used at the same time as antibiotics and bronchodilators. Erdomed with food and drink: Erdomed can be taken before, during and after meals. Pregnancy, breast-feeding and fertility: If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Erdomed should not be used during pregnancy and lactation. Driving and using machines: Erdomed has no or negligible influence on the ability to drive and use machines. Erdomed contains sucrose and sodium: If your doctor has told you that you have an intolerance to some sugars, contact him before taking this medicinal product. This medicine contains less than 1 mmol sodium (23 mg) per sachet, i.e. it can be said to be practically sodium-free. 3. How to take Erdomed Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. Adults: The recommended dose is 1 sachet 2-3 times a day. The maximum daily dose is 900 mg, divided into 2-3 doses. Children over 12 years: 1 sachet twice a day. Dissolve the contents of the sachet in about 120 ml of room temperature liquid (water, tea) and drink it. Stir if necessary until a slightly cloudy suspension is obtained. Take by mouth immediately after dissolution. The therapeutic effect becomes significant after the third day of treatment. The average duration of treatment to obtain the full effect is 7 days. In chronic diseases, Erdomed can be used for a long time. If you have taken more than the required dose of Erdomed: At doses exceeding the therapeutic ones (1200 mg/day), sweating, dizziness and facial flushing have been reported. If you forget to take Erdomed: Do not take a double dose to make up for the missed dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everyone gets them. Very rarely, headache, feeling cold, difficulty breathing may occur. Also reported are changes in taste, nausea, vomiting, diarrhea, stomach pain. Possible dermatological side effects, occurring very rarely, are urticaria, redness, eczema. Reporting of side effects: If you get any side effects, tell your doctor or pharmacist. This includes any possible side effects not described in this leaflet. You can also report side effects directly via the national reporting system: Executive Agency for Medicines website: bda.bg By reporting side effects, you can contribute to obtaining more information on the safety of this medicine. 5. How to store Erdomed Store below 25°C. Keep out of the reach and sight of children. Do not use this medicine after the expiry date which is stated on the carton. The expiry date corresponds to the last day of that month. Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information What Erdomed powder for oral solution contains: Active substance: 225 mg erdosteine (erdosteine) Other ingredients: sucrose, sodium starch glycolate, colloidal silicon dioxide, hydrated, sucralose, orange essence (corn maltodextrin, alpha tocopherol (E307)), malic acid, anhydrous. What Erdomed powder for oral solution contains: Active substance: 225 mg erdosteine (erdosteine) Other ingredients: sucrose, sodium starch glycolate, colloidal silicon dioxide, hydrated, sucralose, orange essence (corn maltodextrin, alpha tocopherol (E307)), malic acid, anhydrous. What Erdomed looks like and contents of the pack: ERDOMED 225 mg powder for oral solution is a fine, free-flowing white powder with a characteristic pleasant aroma and taste. ERDOMED 225 mg is available in cardboard boxes containing 20 sachets and an attached patient leaflet. What you need to know before you take Erdomed Do not take Erdomed: if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6); if you suffer from liver cirrhosis or cystathionine synthetase enzyme deficiency; if you suffer from a congenital disease of amino acid metabolism and in particular if you need to follow a methionine-free diet; if you have severe kidney failure (creatinine clearance < 25 ml/min). Warnings and precautions: Talk to your doctor or pharmacist before taking Erdomed. Children and adolescents: Do not give Erdomed 225 mg to children under 12 years of age. Other medicines and Erdomed: You should tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Erdomed should not be used at the same time as cough suppressants, as this may cause mucus to build up in the bronchial tree. Erdomed can be administered at the same time as antibiotics and bronchodilators. Erdomed with food and drink: Erdomed can be taken before, during and after meals. Pregnancy, breast-feeding and fertility: If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine. Erdomed should not be used during pregnancy and breast-feeding. Driving and using machines: Erdomed has no or negligible influence on the ability to drive and use machines. Erdomed contains sucrose and sodium: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. This medicine contains less than 1 mmol sodium (23 mg) per sachet, i.e. it can be said that it is practically sodium-free. How to take Erdomed Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. Adults: The recommended dose is 1 sachet 2-3 times a day. The maximum daily dose is 900 mg, divided into 2-3 doses. Children over 12 years: 1 sachet twice a day. Dissolve the contents of the sachet in about 120 ml of room temperature liquid (water, tea) and drink it. Stir if necessary until a slightly cloudy suspension is obtained. Take by mouth immediately after dissolution. The therapeutic effect becomes significant after the third day of treatment. The average duration of treatment to obtain the full effect is 7 days. In chronic diseases, Erdomed can be used for a long time. If you take more Erdomed than you should: At doses exceeding the therapeutic dose (1200 mg/day), sweating, dizziness and flushing of the face have been reported. If you forget to take Erdomed: Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Very rarely, headache, feeling cold, difficulty breathing may occur. Also, changes in taste, nausea, vomiting, diarrhea, stomach pain have been reported. Possible dermatological side effects, which occur very rarely, are urticaria, redness, eczema.