Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
ACETYLCYSTEIN
Essential-Healthcare Ltd.
R05CB; R05CB01
ACETYLCYSTEIN
600 milligram(s)
Effervescent tablet
Product subject to prescription which may not be renewed (A)
Mucolytics; acetylcysteine
Not marketed
2018-03-29
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. - Ask your pharmacist if you need more information or advice. - 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. - You must talk to a doctor if you do not feel better or if you feel worse after 14 days. What is in this leaflet 1. What Acetylcysteine Essential-Healthcare 600mg Effervescent Tablets is and what it is used for 2. What you need to know before you take Acetylcysteine Essential-Healthcare 600mg Effervescent Tablets 3. How to take Acetylcysteine Essential-Healthcare 600mg Effervescent Tablets 4. Possible side effects 5. How to store Acetylcysteine Essential-Healthcare 600mg Effervescent Tablets 6. Contents of the pack and other information 1. What Acetylcysteine Essential-Healthcare 600mg Effervescent Tablets is and what it is used for Acetylcysteine breaks down tough, sticky mucus, so that the liquid is thin and can be easily coughed up. This medicine can be used in respiratory diseases such as bronchitis, emphysema, mucoviscidose and bronchiectasis. You must talk to a doctor if you do not feel better or if you feel worse after 14 days. Acetylcysteine Essential-Healthcare 600mg Effervescent Tablets is indicated for adults only. Warnings and precautions Talk to your doctor or pharmacist before taking Acetylcysteine Essential-Healthcare 600mg Effervescent Tablets Ÿ If your child is between 2 and 18 years of age. Other forms and strengths of acetylcysteine are more suitable for these patient groups. Ÿ If you suffer from bronchial asthma, you can also suffer from bronchospasms. If this occurs, immediately stop the treatment and consult a doctor. Ÿ If you have a history of stomach ulcers, because Acetylcysteine Essential-Healthca Belgenin tamamını okuyun
Health Products Regulatory Authority 14 January 2021 CRN00C3VF Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Acetylcysteine Essential-Healthcare 600 mg effervescent tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each effervescent tablet contains 600 mg acetylcysteine. Excipient(s) with known effect: contains sodium (146 mg per tablet) and aspartame (20 mg per tablet, equal to 11 mg phenylalanine). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Effervescent tablet. White, round and smooth effervescent tablets. Thickness: 4.95 mm; diameter: 18.0 mm 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Acetylcysteine is indicated for pulmonary conditions, requiring viscosity reduction of the bronchial secretion to facilitate productive coughing, such as in bronchitis, emphysema, mucoviscidose, and bronchiectasis. Acetylcysteine Essential-Healthcare 600 mg Effervescent Tablets is indicated in adults _only_. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_ 600 mg (1 effervescent tablet) once daily. _Paediatric population_ Children under 2 years of age Acetylcysteine Essential-Healthcare 600mg Effervescent Tablets is contraindicated for use in children under 2 years of age (see section 4.3). Children 2 years of age and older, and adolescents The safety and efficacy is not established in children aged 2 years and older and adolescents. Other forms and strengths of acetylcysteine are more suitable for these patient groups. Method of administration Administer the required dose by dissolving an effervescent tablet in half a glass of water, to obtain a solution which can be ingested directly. Patients with a muffled cough reflex (elderly and debilitated patients) are advised to take the tablet in the morning. Health Products Regulatory Authority 14 January 2021 CRN00C3VF Page 2 of 6 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. The tablets should not be used in children under 2 years of a Belgenin tamamını okuyun