Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Budesonide
Mylan IRE Healthcare Limited
R03BA; R03BA02
Budesonide
400 microgram(s)
Powder for Inhalation
Product subject to prescription which may be renewed (B)
Glucocorticoids; budesonide
Not marketed
2005-12-22
PACKAGE LEAFLET: INFORMATION FOR THE USER NOVOLIZER BUDESONIDE® 400 MICROGRAMS INHALATION POWDER Budesonide 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 only. Do not pass it on to others. It may harm them, even if their symptoms 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 Budesonide 400 micrograms is and what it is used for 2. What you need to know before you use Novolizer Budesonide 400 micrograms 3. How to use Novolizer Budesonide 400 micrograms 4. Possible side effects 5. How to store Novolizer Budesonide 400 micrograms 6. Contents of the pack and other information 1. WHAT NOVOLIZER BUDESONIDE 400 MICROGRAMS IS AND WHAT IT IS USED FOR Budesonide, the active substance in Novolizer Budesonide 400 micrograms, is a glucocorticoid (corticosteroid) for inhalation. Novolizer Budesonide 400 micrograms is used for regular treatment of persistent asthma. NOTE: Novolizer Budesonide 400 micrograms should not be used for treatment of a sudden attack of respiratory distress (acute asthma attack or Status asthmaticus (asthma attacks occurring very frequently and/or persisting for several days)). 2. WHAT YOU NEED TO KNOW BEFORE YOU USE NOVOLIZER BUDESONIDE 400 MICROGRAMS DO NOT USE NOVOLIZER BUDESONIDE 400 MICROGRAMS if you are allergic to budesonide or to milk proteins, that are contained in small amounts in the excipient lactose monohydrate. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Novolizer Budesonide. Contact your doctor if you experience blurred vision or other visual disturbances. TAKE SPECIAL CARE IN USING NOVOLIZER BUDESONIDE 400 MICROGRAMS , if you are suffering from lung t Baca dokumen lengkap
Health Products Regulatory Authority 26 November 2020 CRN00C1X4 Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Novolizer Budesonide 400 micrograms inhalation powder 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Budesonide One delivered dose contains 400 micrograms of budesonide. Excipient with known effect: 10.5 mg of lactose monohydrate/delivered dose The delivered dose is the dose which is available for the patient after passing the mouthpiece. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Inhalation powder. White powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Regular treatment of persistent asthma. Note: budesonide is not intended to be used as a reliever of acute asthma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology If a patient is switched to Novolizer Budesonide 400 micrograms from an alternative inhalation device the dose should be reviewed and adjusted, as necessary, on an individual basis. The active substance, dose regimen and method of delivery should be considered. Steroid naive patients and patients previously controlled on inhaled steroids: Adults (including older people) and children/adolescents over 12 years of age: Initial recommended dose: 200- 400 micrograms once or twice daily Maximum recommended dose: 800 micrograms twice daily Children 6 - 12 years: Initial recommended dose: 200 micrograms twice or 200 –400 micrograms once daily Maximum recommended dose: 400 micrograms twice daily Children below 6 years of age: Novolizer Budesonide 400 micrograms is not recommended for use in children below age 6 due to insufficient data on safety and efficacy. Note: For the 200 micrograms doses a 200 micrograms strength is available. Health Products Regulatory Authority 26 November 2020 CRN00C1X4 Page 2 of 10 The dose should be adapted to the requirements of each individual, the severity of the disease and the clinical response of the patient. The dose should be adjusted until control is achieved and then should be t Baca dokumen lengkap