Ország: Málta
Nyelv: angol
Forrás: Medicines Authority
CARBOCISTEINE
Dompe Farmaceutici SpA Via San Martino 12, 20122, Milan, Italy
R05CB03
CARBOCISTEINE 1.35 g
POWDER FOR ORAL SOLUTION
CARBOCISTEINE 1.35 g
OTC
COUGH AND COLD PREPARATIONS
Authorised
2018-06-04
Page 1 of 4 PACKAGE LEAFLET: INFORMATION FOR THE USER FLUIFORT 1.35 G POWDER FOR ORAL SOLUTION Carbocisteine lysine salt 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 have any further questions, ask your pharmacist. - If you develop any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See paragraph 4. - You must talk to a doctor if you do not feel better or if you feel worse. WHAT IS IN THIS LEAFLET 1. What Fluifort is and what it is used for 2. What you need to know before you take Fluifort 3. How to take Fluifort 4. Possible side effects 5. How to store Fluifort 6. Contents of the package and other information 1. WHAT FLUIFORT IS AND WHAT IT IS USED FOR Fluifort contains the active ingredient carbocisteine lysine salt monohydrate which belongs to a group of medicinal products for coughs and colds called mucolytics which are used to facilitate the elimination of mucus from the airways. This medicine is indicated for the treatment of coughs and acute and chronic diseases of the respiratory system. You must talk to a doctor if you do not feel better or if you feel worse. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUIFORT DO NOT TAKE FLUIFORT - if you are allergic to carbocisteine lysine salt monohydrate or to any of the other components of this medicine (listed in paragraph 6); - if you suffer from a gastroduodenal ulcer, a problem that may affect the stomach or the first part of the bowel; - if you are pregnant or breastfeeding (see paragraph “Pregnancy and breastfeeding”). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Fluifort if: - you are elderly or debilitated - you have serious respiratory problems - you have asthma or a history of asthma - you have a history of stomac Olvassa el a teljes dokumentumot
Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Fluifort 1.35 g powder for oral solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains: active ingredient: carbocisteine lysine salt monohydrate equivalent to 1.35 g carbocisteine lysine salt Excipients with known effect: sucrose, aspartame. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for oral solution Powder that rapidly dissolves in hot water and gives rise to an amber solution that releases a characteristic balsamic flavour of menthol, eucalyptus and honey. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Mucolytic drug, fluidifying agent in the acute and chronic diseases of the respiratory system. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults and adolescents above 15 years: one sachet 2-3 times daily or as directed by a health care professional. In consideration of the pharmacokinetic properties and of the high tolerability, the recommended posology may be kept in patients with renal and liver failure, too. Method of administration For oral use only. Dissolve the content of the sachet according to the instructions presented in section 6.6. Can be taken either with or without food. Duration of treatment Page 2 of 6 Carbocisteine monohydrate lysine salt may be used for longer periods of time. However, if after 2 weeks of therapy the symptoms are not resolved, it is advisable to seek medical advice 4.3 CONTRAINDICATIONS Hypersensitivity to the active ingredient or to any of the excipients. Gastric-duodenal ulcer. Pregnancy and lactation. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Severe respiratory failure, asthma and debilitating conditions Special precautions should be taken in patients with severe respiratory failure, in patients with asthma and with a history of bronchospasm, as well as in patients with debilitating conditions. The use of carbocisteine causes a decrease in mucus viscosity and an increase in mucus removal, both through the ciliary activity of Olvassa el a teljes dokumentumot