Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Acetylcysteine
Stirling Anglian Pharmaceuticals Ltd
R05CB; R05CB01
Acetylcysteine
600 milligram(s)
Effervescent tablet
Mucolytics; acetylcysteine
2019-07-19
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT600 MG EFFERVESCENT TABLETS For adults acetylcysteine 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 Preberite celoten dokumentis and what it is used for 2. What you need to know before you take 3. How to take 4. Possible side effects 5. How to store 6. Contents of the pack and other information 1. WHAT IS AND WHAT IT IS USED FOR contains the active substance acetylcysteine. Acetylcysteine belongs to a group of medicines called mucolytics which work by thinning the mucus (phlegm) so that it can be coughed up more easily. is used to loosen mucus and to ease coughing up in cases of respiratory diseases with viscous mucus. It should be used in adults only. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DO NOT TAKE if you are allergic to acetylcysteine or any of the other ingredients of this medicine (listed in section 6). in children under 2 years Medicines that dissolve phlegm can block the airways of young children, must not be used in children under 2 years of age. Due to the high active substance content, must not be used in children and adolescents . Medicines in a suitable strength are available for this. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking . If you suffer from bronchial asthma, do not take this medicine. Very rare skin
Health Products Regulatory Authority 22 July 2019 CRN008LM2 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Acetylcysteine Stirling Anglian 600 mg effervescent tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each effervescent tablet contains 600 mg acetylcysteine. Excipients with known effect Each effervescent tablet contains: -6.04 mmol (138.79 mg) sodium -70 mg of lactose -0.52 mg of sorbitol (E420) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Effervescent tablet White, round tablets with a score line on one side. The effervescent tablets have a diameter of 20 mm. The score line is not intended for breaking the tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Acetylcysteine Stirling Anglian is indicated in adults as a mucolytic agent for the treatment of respiratory tract diseases in which a reduction in bronchial secretion viscosity is required to facilitate expectoration. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults: _ 600 mg acetylcysteine once daily. _Paediatric population:_ _ _ _Children aged 2 years and older, and adolescents_ The safety and efficacy of Acetylcysteine Stirling Anglian in children aged 2 years and older, and adolescents, have not been established. _Children under 2 years of age_ Acetylcysteine Stirling Anglian is contraindicated in children 0 to 2 years (see sections 4.3 and 4.4). _Duration of therapy_ Duration of therapy should be determined by the clinician, depending on the nature and severity of the condition Method of administration For oral use Before oral use the tablet should be dissolved in half a glass of water. Acetylcysteine Stirling Anglian should be taken after food. Health Products Regulatory Authority 22 July 2019 CRN008LM2 Page 2 of 7 _Hepatic and renal impairment_ _ _ Hepatic and renal impairment can reduce clearance and increase acetylcysteine plasma levels which may results in an increase in adverse drug reactions due to drug accumulation. 4.3 CONTRAINDICATIONS Hypersensitivity to the a Preberite celoten dokument