Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
Acetylcysteine
Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
R05CB; R05CB01
Acetylcysteine
600 milligram(s)
Powder for oral solution
Mucolytics; acetylcysteine
Not marketed
2020-06-19
P A C K A G E L E A F L E T : I N F O R M A T I O N F O R T H E U S E R U133.... 04.2020 READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • 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 Trebon is and what it is used for 2. What you need to know before you take Trebon 3. How to take Trebon 4. Possible side effects 5. How to store Trebon 6. Contents of the pack and other information 1. WHAT TREBON IS AND WHAT IT IS USED FOR Trebon contains the active substance acetylcysteine and dissolves thick mucus in the airways. Trebon is used to loosen mucus and to ease coughing up in cases of lung diseases such as chronic bronchitis in adults. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TREBON DO NOT TAKE TREBON • If you are allergic to acetylcysteine or any of the ingredients of this medicine (listed in section 6). • Children under 2 years of age must not take Trebon. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Trebon if you have • asthma If you have asthma then you should not take this medicine. • skin and lining of the mouth and groin changes The occurrence of severe skin reactions, has very rarely been reported in connection with the use of acetylcysteine. If you experience any skin and lining of the mouth and groin changes, you should immediately stop taking this product and inform your doctor. • a history of stomach or bowel ulcers or currently have them. • if you are allergic to histamine Long-term therapy should be avoided in these patients, since taking Trebon may lead to symptoms of intolerance (e.g. read_full_document
Health Products Regulatory Authority 19 June 2020 CRN008K7F Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Trebon 600 mg powder for oral solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet with powder used for the preparation of oral solution contains 600 mg of acetylcysteine. Excipients with known effect Each sachet contains 2,167.9 mg sorbitol and 9.5 mg sucrose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral solution White powder with lemon flavour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Trebon is indicated in adults as a mucolytic therapy in chronic bronchitis and other respiratory conditions associated with thick mucus hypersecretion. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology In general the usual recommended dosage is: 600mg once daily The dosage may be increased according to the instructions of the treating doctor based on the assessment of treatment outcomes. Duration of treatment The duration of therapy is dependent on the nature and severity of the illness, and should be decided by the doctor. _Paediatric population_ Children older than 2 years of age and adolescents The safety and efficacy of Trebon is not established in children aged 2 years and older and adolescents (see section 4.4). Other products with lower strengths of acetylcysteine are more suitable for this age group. Children under 2 years of age Trebon is contraindicated in children aged under 2 years (see section 4.3). _Elderly_ Limited data in patients over 65 years of age is available. _Renal and hepatic impairment_ In patients with renal or hepatic impairment there is insufficient data on whether dosage adjustments are required. Renal and hepatic impairment can reduce clearance and increase acetylcysteine plasma levels which may result in an increase in adverse drug reactions due to drug accumulation (see section 5.2). Method of administration Dissolve the content of one sachet in half a glass of water. This produces a solution that s read_full_document