Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Beclometasone dipropionate
Norton Waterford
R03BA; R03BA01
Beclometasone dipropionate
250 Mcg/Acutuation
Pressurised inhalation, solution
Product subject to prescription which may be renewed (B)
Glucocorticoids; beclometasone
Marketed
1997-11-14
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BECLAZONE 100, 250 MICROGRAMS EASI-BREATHE CFC-FREE INHALER 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 Beclazone Easi-Breathe CFC-Free Inhaler is and what it is used for 2. What you need to know before you use Beclazone Easi-Breathe CFC-Free Inhaler 3. How to use Beclazone Easi-Breathe CFC-Free Inhaler 4. Possible side effects 5. How to store Beclazone Easi-Breathe CFC-Free Inhaler 6. Contents of the pack and other information 1 WHAT BECLAZONE EASI-BREATHE CFC-FREE INHALER IS AND WHAT IT IS USED FOR Beclazone Easi-Breathe CFC-Free Inhaler contains the active substance beclometasone dipropionate, which belongs to a group of medicines called corticosteroids. (often just called steroids). A very small dose of steroid is needed when it is inhaled. This is because it is inhaled straight to your lungs. Beclazone Easi-Breathe CFC-Free Inhaler works by reducing swelling and irritation in the lungs. It has what is called an ‘anti-inflammatory action’. Beclazone Easi-Breathe CFC-Free Inhaler helps to prevent asthma attacks in people who need regular treatment. This is why it is sometimes called a 'preventer'. It needs to be used regularly, every day. Beclazone Easi-Breathe CFC-Free Inhaler will not help treat sudden asthma attacks where you feel breathless. • A different medicine is used for treating sudden attacks (called a ‘reliever Read the complete document
Health Products Regulatory Authority 11 December 2023 CRN00DP1X Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Beclazone 250 micrograms Easi-Breathe CFC-Free Inhaler Pressurised Inhalation Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered dose contains 250 micrograms beclometasone dipropionate. Excipient with known effect: Each metered dose contains 6.00 mg alcohol (ethanol). 3 PHARMACEUTICAL FORM Pressurised inhalation, solution. Pressurised container fitted with a metering valve and a breath-operated actuator. The colour of the actuator is wine with a pink dust cap. 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 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 (see section 4.2) or oral corticosteroid therapy. Sudden worsening of symptoms may require increased corticosteroid dosage which should be administered under urgent medical supervision. Prophylactic management in: Mild asthma (PEF values greater than 80% predicted at baseline with less than 20% variability): Patients requiring intermittent symptomatic bronchodilator asthma medication on more than an occasional basis. Moderate asthma (PEF values 60 - 80% predicted at baseline with 20 - 30% variability): Patients requiring regular asthma medication and patients with unstable or worsening asthma on other prophylactic therapy or bronchodilator alone. Severe asthma (PEF values less than 60% predicted at baseline with greater than 30% variability): Patients with severe chronic asthma. Beclazone 250 micrograms Easi-Breathe CFC-Free Inhaler is indicated in adults and adolescents 12 years of age and older. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The preparation is intended for oral in Read the complete document