País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
Salbutamol
Mylan IRE Healthcare Limited
R03AC; R03AC02
Salbutamol
100 microgram(s)
Powder for Inhalation
Product subject to prescription which may be renewed (B)
Selective beta-2-adrenoreceptor agonists; salbutamol
Not marketed
2004-09-30
1 PACKAGE LEAFLET: INFORMATION FOR THE USER NOVOLIZER SALBUTAMOL 100 micrograms / dose Inhalation Powder Salbutamol READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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. 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 Novolizer Salbutamol is and what it is used for 2. What you need to know before you use Novolizer Salbutamol 3. How to use Novolizer Salbutamol 4. Possible side effects 5. How to store Novolizer Salbutamol 6. Contents of the pack and other Information 1. WHAT NOVOLIZER SALBUTAMOL IS AND WHAT IT IS USED FOR Novolizer Salbutamol is indicated in adults, adolescents and children aged 6 to 12 years. The active substance in Novolizer Salbutamol is an anti-asthmatic agent for bronchodilation (beta sympathomimetic agent). Novolizer Salbutamol is used for - Symptomatic treatment of conditions with associated reversible airway obstruction, e.g. asthma or chronic obstructive pulmonary disease (COPD) with a substantial component of reversibility. - Prevention of asthma attacks induced by exercise or exposure to allergens. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE NOVOLIZER SALBUTAMOL DO NOT USE NOVOLIZER SALBUTAMOL if you are allergic (hypersensitive) to Salbutamol or to lactose and/or to the milk protein contained therein. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Novolizer Salbutamol TAKE SPECIAL CARE IN USING NOVOLIZER SALBUTAMOL, if you are suffering from one of the following conditions - Severe cardiac disease, in particular fresh myocardial infarction, - Disease of the coronary vessels (coronary heart disease), a cert Leer el documento completo
Health Products Regulatory Authority 26 November 2020 CRN00C1X4 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Novolizer Salbutamol 100 micrograms/dose inhalation powder 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One delivered dose contains 100 micrograms of salbutamol equivalent to 120 micrograms of salbutamol sulphate. The delivered dose is the dose which is available for the patient after passing the mouthpiece. Excipient: 11.42 milligrams of lactose monohydrate/delivered dose. 3 PHARMACEUTICAL FORM Inhalation powder. White powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Novolizer Salbutamol is indicated in adults, adolescents and children aged 6 to 12 years. Symptomatic treatment of conditions with associated reversible airway obstruction, e.g. asthma or chronic obstructive pulmonary disease with a substantial component of reversibility. Prevention of asthma attacks induced by exercise or exposure to allergens. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose depends on the type, severity, and course of the disorder. _Asthma_ Adults (including older and adolescents) For the relief of acute symptoms including bronchospasm a starting dose of one inhalation (100 micrograms) is recommended for adults. For prevention of exercise-induced or allergen induced symptoms two inhalations (200 micrograms) should be taken 10-15 minutes prior to challenge. The maximum on-demand use in any 24 hours should not exceed 8 inhalations (equivalent to 800 micrograms). Children (aged 6 to 12 years) For the relief of acute symptoms including bronchospasm a starting dose of one inhalation (100 micrograms) is recommended for children aged 6 years and above. For prevention of exercise-induced or allergen induced symptoms one inhalation (100 micrograms) should be taken10-15 minutes prior to challenge and a further inhalation (to a total of 200 micrograms), if necessary. The maximum on-demand use in any 24 hours should not exceed 4 inhalations (equivalent to 400 micrograms). Children b Leer el documento completo