Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Tiotropium
PCO Manufacturing Ltd.
R03BB; R03BB04
Tiotropium
18 microgram(s)
Inhalation powder, hard capsule
Product subject to prescription which may be renewed (B)
Anticholinergics; tiotropium bromide
Authorised
2007-08-24
_Pil 465-186-1-7597_ _ _ _ _ _Pil 465-186-1-7597_ _ _ PACKAGE LEAFLET : INFORMATION FOR THE USER SPIRIVA ® 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 SPIRIVA 18 microgram is and what it is used for 2. What you need to know before you use SPIRIVA 18 microgram 3. How to use SPIRIVA 18 microgram 4. Possible side effects 5. How to store SPIRIVA 18 microgram 6. Contents of the pack and other information 1. WHAT SPIRIVA 18 MICROGRAM IS AND WHAT IT IS USED FOR SPIRIVA 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 take SPIRIVA 18 microgram every day and not only when you have breathing problems or other symptoms of COPD. SPIRIVA 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 SPIRIVA 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 SPIRIVA 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 hour Les hele dokumentet
Health Products Regulatory Authority 15 June 2020 CRN009S7D Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Spiriva 18 microgram inhalation powder, hard capsule 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 22.5 microgram tiotropium bromide monohydrate equivalent to 18 microgram tiotropium. The delivered dose (the dose that leaves the mouthpiece of the HandiHaler device) is 10 microgram tiotropium. Excipient with known effect: Lactose monohydrate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Inhalation powder, hard capsule. _Product imported from Germany, Spain, Italy, theUnited Kingdom,France, Greece, Romania, Lithuania, Norway and Poland:_ Light green hard capsules with the product code 'TI 01' and company logo printed on the capsule. 4 CLINICAL PARTICULARS As per PA0775/002/001. 5 PHARMACOLOGICAL PROPERTIES As per PA0775/002/001. 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Lactose monohydrate (which may contain small amounts of milk proteins). 6.2 INCOMPATIBILITIES Not applicable 6.3 SHELF LIFE The shelf-life expiry date of this product is the date shown on the container and outer package of the product on the market in the country of origin. After first opening of the blister: 9 days Discard the Handihaler device 12 months after first use. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25°C Do not freeze 6.5 NATURE AND CONTENTS OF CONTAINER Blister strips containing 10 capsules The HandiHaler is a single dose inhalation device. Package sizes and devices supplied: • Cardboard box containing 30 capsules (3 blister strips) Health Products Regulatory Authority 15 June 2020 CRN009S7D Page 2 of 2 • Cardboard box containing 60 capsules (6 blister strips) • Cardboard box containing HandiHaler device and 30 capsules (3 blister strips) Not all pack sizes may be marketed. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL Any unused medicinal product or waste material should be disposed of in accordance with local requirements. 7 PARALLEL Les hele dokumentet