Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
Tiotropium
IMED Healthcare Ltd.
R03BB; R03BB04
Tiotropium
2.5 microgram(s)
Solution for Inhalation
Product subject to prescription which may be renewed (B)
Anticholinergics; tiotropium bromide
Authorised
2012-11-16
PACKAGE LEAFLET: INFORMATION FOR THE USER SPIRIVA® RESPIMAT® 2.5 MICROGRAM, SOLUTION FOR INHALATION Tiotropium READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 SPIRIVA RESPIMAT is and what it is used for 2. What you need to know before you take SPIRIVA RESPIMAT 3. How to take SPIRIVA RESPIMAT 4. Possible side effects 5. How to store SPIRIVA RESPIMAT 6. Contents of the pack and further information 1. WHAT SPIRIVA RESPIMAT IS AND WHAT IT IS USED FOR SPIRIVA RESPIMAT helps people who have chronic obstructive pulmonary disease (COPD) or asthma to breathe more easily. COPD is a long-term lung disease that causes shortness of breath and coughing. The term COPD is associated with the conditions chronic bronchitis and emphysema. Asthma is a long-term disease characterised by airway inflammation and narrowing of the airways. As COPD and asthma are long-term diseases you should take Spiriva Respimat every day and not only when you have breathing problems or other symptoms. When used to treat asthma you should use Spiriva Respimat in addition to so- called inhaled corticosteroids and long-acting β2 agonists. SPIRIVA RESPIMAT 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 SPIRIVA RESPIMAT can also help you when you have ongoing shortness of breath related to your disease, and will help to minimise the effects of the disease on your everyday life. Daily use of SPIRIVA RESPIMAT will also help to prevent any sudd Lue koko asiakirja
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Spiriva Respimat 2.5 microgram, solution for inhalation 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The delivered dose is 2.5 microgram tiotropium per puff (2 puffs comprise one medicinal dose) and is equivalent to 3.124 microgram tiotropium bromide monohydrate. The delivered dose is the dose which is available for the patient after passing the mouthpiece. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for inhalation _Product imported from Italy_ Clear, colourless, solution for inhalation 4 CLINICAL PARTICULARS As per PA0775/002/002. 5 PHARMACOLOGICAL PROPERTIES As per PA0775/002/002. 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Benzalkonium chloride Disodium edetate Water, purified Hydrochloric acid 3.6 % (for pH adjustment) 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf-life expiry date of this product shall be the date shown on the container and outer package of the product on the market in the country of origin. In-use shelf life: 3 months 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not freeze. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _0_ _2_ _/_ _0_ _5_ _/_ _2_ _0_ _1_ _8_ _C_ _R_ _N_ _ _ _2_ _2_ _0_ _6_ _3_ _1_ _6_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.5 NATURE AND CONTENTS OF CONTAINER Pack size and device supplied: Single pack: 1 Respimat inhaler and 1 cartridge, providing 60 puffs (30 medicinal doses) 6.6 SPECIAL PRECAUTIONS FOR DIS Lue koko asiakirja