Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Tiotropium
IMED Healthcare Ltd.
R03BB; R03BB04
Tiotropium
18 microgram(s)
Inhalation powder, hard capsule
Anticholinergics; tiotropium bromide
2006-11-27
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 micrograms is and what it is used for 2. What you need to know before you use SPIRIVA 18 micrograms 3. How to use SPIRIVA 18 micrograms 4. Possible side effects 5. How to store SPIRIVA 18 micrograms 6. Contents of the pack and other information 1. WHAT SPIRIVA 18 MICROGRAMS 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 SPIRIVA18 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. For correct Přečtěte si celý dokument
Health Products Regulatory Authority 09 October 2020 CRN009XJ3 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 the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Inhalation powder, hard capsule _Product imported from Bulgaria, France, Italy, Romania, Spain and the UK:_ Light green hard capsules containing the inhalation powder 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 blister strips and outer carton of the product as marketed in the country of origin. After first opening of the blister use within the next 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 Health Products Regulatory Authority 09 October 2020 CRN009XJ3 Page 2 of 2 Cardboard box containing HandiHaler device and 3 blister strips (3 x 10 capsules) Cardboard box containing 3 blister strips (3 x 10 capsules) 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 PRODUCT AUTHORISATION HOLDER IMED Healthcare Ltd. Unit 625 Kilshane Avenue Northwest Business Park Ballycoolin Dublin 15 Ireland 8 PARALLEL PRODUCT AUTHORISATION NUM Přečtěte si celý dokument