Država: Malta
Jezik: angleščina
Source: Medicines Authority
BUDESONIDE
Novartis Pharmaceuticals UK Limited Frimley Business Park, Frimley Camberley, Surrey GU16 7SR, United Kingdom
R03BA02
BUDESONIDE 200 µg
INHALATION POWDER
BUDESONIDE 200 µg
POM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
Withdrawn
2007-01-04
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER MIFLONIDE BREEZHALER 200 MICROGRAM INHALATION POWDER, HARD CAPSULE MIFLONIDE BREEZHALER 400 MICROGRAM INHALATION POWDER, HARD CAPSULE Budesonide READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects affects you severely, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Miflonide is and what it is used for 2. What you need to kno wbefore you use Miflonide Breezhaler 3. How to use Miflonide Breezhaler 4. Possible side effects 5. How to store Miflonide Breezhaler 6. Contents of the pack and other information 1. WHAT MIFLONIDE BREEZHALER IS AND WHAT IT IS USED FOR WHAT MIFLONIDE BREEZHALER IS Miflonide Breezhaler is provided as a capsule to be put in an inhaler called Miflonide Breezhaler ® . The inhaler opens the capsule and releases a dry powder that is delivered to the lungs by breathing in. Miflonide Breezhaler contains a substance called budesonide. It belongs to a group of medicines called “corticosteroids”. Some people call this their “steroid” or “preventer” medicine. WHAT MIFLONIDE BREEZHALER IS USED FOR Long term (maintenance) treatment of asthma in adults and children 6 years of age and older Chronic obstructive bronchitis (inflammation of the membrane lining bronchial tubes, which is part of the so called chronic obstructive pulmonary diseases, i.e. COPD) in adults. HOW MIFLONIDE BREEZHALER WORKS Asthma is caused by inflammation of the small airways in your lungs, which become swollen and make it difficult to breathe. Miflonide Breezhaler reduces and prevents the inflammation and swelling of your airways, allowing you to breathe more easily and reduce Preberite celoten dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Miflonide Breezhaler 200 microgram inhalation powder, hard capsules Miflonide Breezhaler 400 microgram inhalation powder, hard capsules_ _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 200 microgram capsule contains 230 micrograms of budesonide and delivers 200 micrograms of budesonide from the mouthpiece of the device when used in conjunction with the (inhaler device called) Miflonide Breezhaler. Each 400 microgram capsule contains 460 micrograms of budesonide and delivers 400 micrograms of budesonide from the mouthpiece of the device when used in conjunction with the (inhaler device called) Miflonide Breezhaler. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Inhalation powder, hard capsule_. _ The 200 microgram capsule has a light pink opaque cap and a colourless transparent body, printed logo/BUDE 200. The 400 microgram capsule has a pink opaque cap and a colourless transparent body, printed logo/BUDE 400. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS BRONCHIAL ASTHMA Miflonide is indicated in asthmatic patients aged 6 years and older for: Long term anti inflammatory control of persistent asthma including prophylaxis of acute exacerbations of asthma. COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE) Chronic obstructive bronchitis, in which corticosteroid therapy is indicated. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dosage should be carefully titrated individually to the minimum effective dose to control asthma symptoms. The lowest dosage in a single capsule is 200 micrograms. If a single dose of less than 200 micrograms is required, this product cannot be used. Miflonide is contraindicated in children under 6 years of age (see section 4.3) ADULTS: Treatment of adults with mild asthma may be initiated at the minimum effective dose of 200 micrograms once daily. Usual recommended dose is 200-1600 micrograms divided in 2 doses. The maintenance dose should be titrated to the lowest dose at which effective cont Preberite celoten dokument