Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
BECLOMETASONE DIPROPIONATE
Chiesi Farmaceutici S.p.A.
R03BA; R03BA01
BECLOMETASONE DIPROPIONATE
400 mcg/1 millilitre(s)
Nebuliser suspension
Product subject to prescription which may be renewed (B)
Glucocorticoids; beclometasone
Not marketed
2005-03-18
1 Leaflet V(0.1) 12.2016 B. PACKAGE LEAFLET 2 Leaflet V(0.1) 12.2016 PACKAGE LEAFLET: INFORMATION FOR THE USER BECLONEB ® 400 MICROGRAMS NEBULISER SUSPENSION BECLONEB ® 800 MICROGRAMS NEBULISER SUSPENSION BECLOMETASONE DIPROPIONATE 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 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. IN THIS LEAFLET: 1. What BECLONEB ® is and what it is used for 2. What you need to know before you use BECLONEB ® 3. How to use BECLONEB ® 4. Possible side effects 5. How to store BECLONEB ® 6. Contents of the pack and other information 1. WHAT BECLONEB® IS AND WHAT IT IS USED FOR BECLONEB ® contains the active substance beclometasone dipropionate. It belongs to a group of medicines called corticosteroids which have an anti-inflammatory action reducing the swelling and irritation in the walls of the airways (e.g. nose, lungs), and so ease breathing problems. BECLONEB ® is indicated to treat asthma in adults and children up to 18 years of age when the use of pressurised or dry powder inhalers is unsatisfactory or inappropriate. BECLONEB ® is also indicated to treat recurrent wheezing in children up to 5 years of age. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE BECLONEB ® DO NOT USE BECLONEB ® : If you are allergic to the active substance or any of the other ingredients of this medicine listed in section 6. WARNINGS AND PRECAUTIONS Talk to you doctor or pharmacist before using BECLONEB ® if any of the following applies to you: You are being, or have ever been, treated for tuberculosis (TB). Your condition seems to be getting worse. Pe read_full_document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Becloneb 400 micrograms/1 ml nebuliser suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml single dose container contains 400 micrograms beclometasone dipropionate anhydrous. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Nebuliser suspension. A white or almost white suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS BECLONEB ® is indicated for the: maintenance treatment of asthma, when the use of pressurised metered dose or dry powder inhalers is unsatisfactory or inappropriate, in adults and children up to 18 years of age; treatment of recurrent wheezing in children up to 5 years of age (see sections 4.2 and 4.4 paediatric population). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The starting dose of nebulised beclometasone dipropionate should take into account the frequency and severity of symptoms. The recommended initial doses are: Adults and adolescents (from 12 years of age) : 800-1,600 micrograms twice daily (total daily dose: 1600 – 3200 micrograms) Children (up 11 years of age): 400-800 micrograms twice daily (total daily dose: 800 – 1600 micrograms) Normally, a daily dose of 3200 micrograms in adults and adolescents and 1600 micrograms in children up to 11 years of age should not be exceeded. After improvement of control of asthma or wheezing, the total daily dose should be reduced to the lowest effective dose and a once daily dosing can be applied. In patients with asthma, BECLONEB ® must be used regularly on a daily basis; the duration of treatment should be defined on the basis of symptoms. In children with recurrent wheezing, if no treatment benefit of is observed within 2-3 months, BECLONEB ® should be discontinued. In addition, the duration of treatment of recurrent wheezing should not exceed 3 months, unless diagnosis of asthma is likely to avoid an unnecessary long-term exposure (see section 4.4). Method of administration H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O read_full_document