Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
BECLOMETASONE DIPROPIONATE
Chiesi Limited
R03BA; R03BA01
BECLOMETASONE DIPROPIONATE
50 microgram(s)
Pressurised inhalation, solution
Product subject to prescription which may be renewed (B)
Glucocorticoids; beclometasone
Not marketed
2005-09-30
PACKAGE LEAFLET: INFORMATION FOR USER CLENIL® MODULITE® 50 micrograms per metered dose pressurised inhalation solution CLENIL® MODULITE® 100 micrograms per metered dose pressurised inhalation solution CLENIL® MODULITE® 200 micrograms per metered dose pressurised inhalation solution CLENIL® MODULITE® 250 micrograms per metered dose pressurised inhalation solution 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. WHAT CLENIL MODULITE IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE CLENIL MODULITE 3. HOW TO USE CLENIL MODULITE 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE CLENIL MODULITE 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT CLENIL MODULITE IS AND WHAT IT IS USED FOR Clenil Modulite is a pressurised inhalation solution used to help PREVENT the symptoms of mild, moderate or severe asthma. The active ingredient, beclometasone dipropionate, is one of a group of medicines called corticosteroids which are often referred to simply as steroids. Steroids have an anti-inflammatory action reducing the swelling and irritation in the walls of the small air passages in the lungs, and so ease breathing problems. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE CLENIL MODULITE DO NOT USE CLENIL MODULITE: • if you are allergic to any of the ingredients of this medicine or to any other medicines used to treat asthma • TO TREAT A SUDDEN ATTACK OF BREATHLESSNESS. It will not help. Use a quick-acting ‘reliever’ inhaler for this purpose and carry it Olvassa el a teljes dokumentumot
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clenil Modulite 50 micrograms per metered dose Pressurised Inhalation Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered dose contains 50 micrograms of beclometasone dipropionate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Pressurised inhalation, solution The solution is clear and colourless. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Severe asthma requires regular medical assessment as death may occur. Patients with severe asthma have constant symptoms and frequent exacerbations, with limited physical capacity and Peak Expiratory Flow (PEF) values below 60 % predicted at baseline with greater than 30 % variability, usually not returning entirely to normal after a bronchodilator. These patients will require high dose inhaled or oral corticosteroid therapy. Sudden worsening of symptoms, which may be potentially life-threatening, may require increased corticosteroid dosage, which should be administered under urgent medical supervision. Clenil Moduilte is indicated for the prophylactic management of mild, moderate, or severe asthma in: Adults _Mild asthma_ (PEF valves greater than 80 % predicted at baseline with less than 20 % variability): Patients requiring intermittent symptomatic bronchodilator asthma medication on a regular basis. _Moderate asthma_ (PEF valves 60 % to 80 % predicted at baseline with 20 % to 30 % variability): Patients with unstable or worsening asthma despite prophylactic therapy or bronchodilator alone. _Severe asthma_ (PEF valves greater than 60 % predicted at baseline with greater than 30 % variability): Patients with severe chronic asthma and those who are dependent on systemic corticosteroids for adequate control of symptoms. Children Any child who requires prophylactic asthma medication. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Clenil Modulite is for oral inhalation use only. A spacer device may be used with Clenil Modulite in patients who have difficulty synchroni Olvassa el a teljes dokumentumot