Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Carbocisteine
Amdeepcha Limited
R05CB03
Carbocisteine
250 mg/5ml
Syrup
Product subject to prescription which may be renewed (B)
carbocisteine
Not marketed
2019-01-18
1 PACKAGE LEAFLET: INFORMATION FOR THE USER MUCOTEX 250 MG/5 ML SYRUP CARBOCISTEINE 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 your doctor has told you. Check with your doctor or pharmacist if you are not sure. . - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Mucotex is and what it is used for 2. What you need to know before you take Mucotex 3. How to take Mucotex 4. Possible side effects 5. How to store Mucotex 6. Contents of the pack and other information 1. WHAT MUCOTEX IS AND WHAT IT IS USED FOR Mucotex 250 mg/5 ml syrup contains a medicine called carbocisteine. This belongs to a group of medicines called “mucolytics” used in the antibacterial treatment of respiratory infections, in the presence of bronchial hypersecretion. It works by making the mucus (catarrh) less sticky. This makes the mucus easier to exit when coughing. Mucotex syrup is used for problems in the airways when there is too much mucus or when it is too sticky. You must talk to your doctor if you do not feel better or if you feel worse. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MUCOTEX DO NOT TAKE MUCOTEX: - if you have a gastroduodenal ulcer; - if you are allergic to carbocisteine or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Mucotex: - Asthmatic patients and with a history of bronchospasm, - Severe respiratory insufficiency, 2 - Debilitated patients. Due to the decrease of the cough reflex, there is risk of obstruction of the a Olvassa el a teljes dokumentumot
Health Products Regulatory Authority 16 January 2020 CRN0099F8 Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mucotex 250 mg/5 ml syrup 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml of Mucotex contains 250 mg of carbocisteine. Excipient(s) with known effect: Each 5 ml of Mucotex contains 7.5 mg of methyl parahydroxybenzoate. Each 5 ml of Mucotex contains 2877.5 mg of sucrose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Syrup Yellow- amber liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Carbocisteine is a mucolytic agent for the adjunctive therapy of respiratory tract disorders characterised by excessive and viscous mucus. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_ Dosage is based upon an initial daily dosage of 2250 mg carbocisteine in divided doses, reducing to 1500 mg daily in divided doses when a satisfactory response is obtained e.g. for normal syrup 15 ml 3 times a day reducing to 10 ml 3 times a day. _Paediatric population_ 2 - 5 years: 1.25 - 2.5ml, four times a day. 6 - 12 years: 5 ml, three times a day. Carbocisteine is contraindicated in children aged less than 2 years. Method of administration Use the measuring device to measure the appropriate amount, whether its use is for an adult or a child. The syringe for oral administration is graduated per 0.25ml. One graduation, 0.25ml corresponds to 12.5mg of carbocisteine. _How to use the syringe:_ Step 1: Check the measurements on the side of the syringe to see how much to fill it. Step 2: Push the syringe's plunger all the way down. Then put the tip of the syringe into the medicine bottle. Step 3: Slowly pull back on the plunger until the syringe fills to the appropriate mark. Make sure there are not any large air bubbles in the syringe. If there are, empty the syringe and try again. Step 4: Place the end of the syringe into the mouth against the cheek and carefully press the plunger down slowly to gently release the medicine. After use rep ace the bottle cap. Wa Olvassa el a teljes dokumentumot