Země: Malta
Jazyk: angličtina
Zdroj: Malta Medicines Authority
BECLOMETASONE DIPROPIONATE
Norton Waterford IDA Industrial Park, Waterford, Ireland
R03BA01
BECLOMETASONE DIPROPIONATE 250 µg
PRESSURISED INHALATION, SOLUTION
BECLOMETASONE DIPROPIONATE 250 µg
POM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
Withdrawn
2006-09-22
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BECLAZONE ® 50, 100, 250 MICROGRAMS CFC-FREE INHALER PRESSURISED INHALATION SOLUTION Beclometasone Dipropionate Anhydrous 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. Seesection 4. WHAT IS IN THIS LEAFLET 1. What Beclazone CFC-Free Inhaler is and what it is used for 2. What you need to know before you use Beclazone CFC-Free Inhaler 3. How to use Beclazone CFC-Free Inhaler 4. Possible side effects 5. How to store Beclazone CFC-Free Inhaler 6. Contents of the pack and other information 1. WHAT BECLAZONE CFC-FREE INHALER IS AND WHAT IT IS USED FOR _Effect _ Beclazone CFC-Free Inhaler contains Beclometasone Dipropionate, which belongs to a group of medicines called corticosteroids. Beclometasone dipropionate works on your lungs to help prevent asthma attacks by reducing the swelling and irritation in the walls of the small air passages. This eases your breathing problems. Very little corticosteroid gets absorbed into your body. This medicine is not the same type of steroid used by body-builders and athletes to increase their performance. _Usage _ Beclazone CFC-Free Inhalers are used to PREVENT asthma in adults, adolescents and children aged 7 to 12 years. This type of medicine is known as a ‘preventer’. You must keep on taking this type of medicine regularly, even when you do not seem to have your asthma symptoms. DO NOT USE Beclazone CFC-Free Inhalers to relieve an asthma attack, wheezing or breathlessness. You will probably need a different kind of medicine in a different colo Přečtěte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Beclazone 250 micrograms CFC-Free Inhaler Pressurised Inhalation Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One metered dose contains 250 micrograms beclometasone dipropionate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Pressurised Inhalation, Solution. Pressurised container fitted with a metering valve and an actuator. The colour of the actuator is wine with a pink dust cap. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Beclazone 250 micrograms CFC-Free Inhaler is indicated for those asthmatic patients who have been shown to require high doses of beclometasone dipropionate to control their symptoms. It may also be indicated for those patients whose asthma is no longer controlled by maximum maintenance doses of bronchodilators and lower doses of BDP. Some patients with severe asthma require oral corticosteroid therapy in addition to BDP_ _for the adequate control of their symptoms. Many of these patients may, on transfer to Beclazone 250 micrograms CFC-Free Inhaler, be able to reduce significantly, or eliminate their requirement for additional oral corticosteroids. Beclazone 250 micrograms CFC-Free Inhaler is indicated in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The preparation is intended for oral inhalation only. For optimum results, beclometasone dipropionate should be used regularly. The initial dose of inhaled beclometasone dipropionate should be appropriate to the severity of the disease. The dose should be titrated to the lowest dose at which effective control of asthma is maintained. _Adults _ The dose range is from 50 mcg twice daily to 500 mcg twice daily (maximum daily dose 1000 mcg) depending on the patient's asthma severity. _ _ The maintenance dose is normally 200-400mcg per day in divided doses. If necessary, higher doses up to 1000mcg daily in divided doses may be used. When asthma symptoms remain under satisfactory control the dose may be gradually reduced to the minimum Přečtěte si celý dokument