Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
TIOTROPIUM; OLODATEROL
Lexon (UK) Ltd
R03AL06
TIOTROPIUM; OLODATEROL
2.5/2.5 Microgram
Inhalation Solution
Product subject to prescription which may be renewed (B)
Adrenergics in combination with anticholinergics
Authorised
2018-06-01
This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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 What Spiolto Respimat is and what it is used for What you need to know before you take Spiolto Respimat . How to take Spiolto Respimat Possible side effects How to store Spiolto Respimat Contents of the pack and other information WHAT SPIOLTO RESPIMAT IS AND WHAT IT IS USED FOR WHAT SPIOLTO RESPIMAT IS Spiolto Respimat contains two active substances called tiotropium and olodaterol. These belong to a group of medicines called long-acting bronchodilators. Tiotropium belongs to the subgroup of anticholinergics; olodaterol belongs to the subgroup of long acting beta 2 agonists. WHAT SPIOLTO RESPIMAT IS USED FOR Spiolto Respimat helps adult patients who have chronic obstructive pulmonary disease (COPD) 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. Spiolto Respimat helps to open your airways and make it easier to get air in and out of the lungs. Regular use of Spiolto Respimat can also help you when you have on-going shortness of breath related to your disease, and will help to minimise the effects of the disease on your everyday life. As COPD is a long-term disease you should take Spiolto Res Lue koko asiakirja
SUMMARY OF PRODUCT CHARACTERISTICS This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1 NAME OF THE MEDICINAL PRODUCT Spiolto Respimat 2.5 microgram/2.5 microgram, inhalation solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The delivered dose is 2.5 microgram tiotropium (as bromide monohydrate) and 2.5 microgram olodaterol (as hydrochloride) per puff. The delivered dose is the dose which is available for the patient after passing the mouthpiece. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Inhalation solution _Product imported from the United Kingdom_ Clear, colourless, inhalation solution 4 CLINICAL PARTICULARS As per PA0775/009/001 5 PHARMACOLOGICAL PROPERTIES As per PA0775/009/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Benzalkonium chloride Disodium edetate Purified water 1M Hydrochloric acid (for pH-adjustment) 6.2 INCOMPATIBILITIES Not applicable 6.3 SHELF LIFE The shelf life expiry date for this product shall be the date shown on the inhaler, cartridge and outer package of the product on the market in the country of origin. In-use shelf life: 3 months 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_ _1_ _/_ _0_ _6_ _/_ _2_ _0_ _1_ _8_ _C_ _R_ _N_ _ _ _2_ _2_ _0_ _4_ _6_ _7_ _3_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _ Lue koko asiakirja