Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Tiotropium
Boehringer Ingelheim International GmbH
R03BB; R03BB04
Tiotropium
18 microgram(s)
Inhalation powder, hard capsule
Product subject to prescription which may be renewed (B)
Anticholinergics; tiotropium bromide
Not marketed
2015-08-13
S10/IE/MT/PI/2 1 PACKAGE LEAFLET: INFORMATION FOR THE USER SRIVASSO 18 MICROGRAM INHALATION POWDER, HARD CAPSULE tiotropium 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. WHAT IS IN THIS LEAFLET : 1. What Srivasso 18 microgram is and what it is used for 2. What you need to know before you useSrivasso 18 microgram 3. How to use Srivasso 18 microgram 4. Possible side effects 5. How to store Srivasso 18 microgram 6. Contents of the pack and other information 1. WHAT SRIVASSO 18 MICROGRAM IS AND WHAT IT IS USED FOR Srivasso 18 microgram helps people who have chronic obstructive pulmonary disease (COPD) to breathe more easily. COPD is a chronic lung disease that causes shortness of breath and coughing. The term COPD is associated with the conditions chronic bronchitis and emphysema. As COPD is a chronic disease you should use Srivasso 18 microgram every day and not only when you have breathing problems or other symptoms of COPD. Srivasso 18 microgram is a long-acting bronchodilator that helps to open your airways and makes it easier to get air in and out of the lungs. Regular use of Srivasso 18 microgram can also help you when you have on-going shortness of breath related to your disease and will help you to minimise the effects of the disease on your everyday life. It also helps you to be active longer. Daily use of Srivasso 18 microgram will also help to prevent sudden, short-term worsening of your COPD symptoms which may last for several days. The effect of this medicine lasts for 24 hours, so you only need to use it once a day. Prečítajte si celý dokument
HealthProductsRegulatoryAuthority 21June2019 CRN0094L4 Page1of13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Srivasso18microgram,inhalationpowder,hardcapsule 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Eachcapsulecontains22.5microgramtiotropiumbromidemonohydrateequivalentto18 microgramtiotropium. Thedelivereddose(thedosethatleavesthemouthpieceoftheHandiHalerdevice)is10 microgramtiotropium. Excipient with known effect: Eachcapsulecontainsapproximately5.5milligramsoflactose(asmonohydrate). Forthefulllistofexcipients,seesection6.1. 3 PHARMACEUTICAL FORM Inhalationpowder,hardcapsule. Lightgreenhardcapsulescontainingtheinhalationpowder,withtheproductcodeTI01andcompanylogoprintedonthe capsule. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tiotropiumisindicatedasamaintenancebronchodilatortreatmenttorelievesymptomsofpatientswithchronicobstructive pulmonarydisease(COPD). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Themedicinalproductisintendedforinhalationuseonly. TherecommendeddosageoftiotropiumbromideisinhalationofthecontentsofonecapsuleoncedailywiththeHandiHaler deviceatthesametimeofday. Therecommendeddoseshouldnotbeexceeded. Tiotropiumbromidecapsulesareonlyforinhalationandnotfororalintake. Tiotropiumbromidecapsulesmustnotbeswallowed. TiotropiumbromideshouldonlybeinhaledwiththeHandiHalerdevice. Special populations Geriatricpatientscanusetiotropiumbromideattherecommendeddose. Renallyimpairedpatientscanusetiotropiumbromideattherecommendeddose.For Prečítajte si celý dokument