User manual BOEHRINGER INGELHEIM SPIRIVA RESPIMAT

[. . . ] FURTHER INFORMATION What SPIRIVA RESPIMAT contains: The active substance is tiotropium. 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. The other ingredients are: Benzalkonium chloride, disodium edetate, purified water, and hydrochloric acid 3. 6 % for pH adjustment. [. . . ] Other uncommon side effects experienced by patients are dizziness, headache, blurred vision, itching, palpitations or irregular heart beat (atrial fibrillation, supraventricular tachycardia). Additionally, you may experience your heart to beat faster, constipation, obstruction of bowel movement (intestinal obstruction including paralytic ileus), an increase of the measured eye pressure (intraocular pressure), eye pain or discomfort, blurred vision, seeing halos around lights or coloured images in association with red eyes (i. e. narrow angle glaucoma), inflammation of the sinuses, dental caries, nausea, urinary tract infection or nose bleeds. Immediate allergic reactions such as rash, nettle rash (urticaria), swelling of the mouth and face or sudden difficulties in breathing (angioneurotic oedema) or other hypersensitivity reactions may occur after administration of SPIRIVA RESPIMAT. In addition, in common with all inhaled medicines, some patients may experience an unexpected tightness of the chest, coughing, wheezing or breathlessness immediately after inhalation. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. Further information Double pack: 2 single packages, each containing 1 Respimat inhaler and 1 cartridge, providing 60 puffs (30 medicinal doses) Triple pack: 3 single packages, each containing 1 Respimat inhaler and 1 cartridge, providing 60 puffs (30 medicinal doses) 8 single packages, each containing 1 Respimat inhaler and 1 cartridge, providing 60 puffs (30 medicinal doses) Eight pack: 1. WHAT SPIRIVA RESPIMAT IS AND WHAT IT IS USED FOR SPIRIVA RESPIMAT helps people 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. As COPD is a long-term disease you should take SPIRIVA RESPIMAT every day and not only when you have breathing problems or other symptoms of COPD. 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 sudden, short-term worsening of your COPD symptoms which may last for several days. How to take SPIRIVA RESPIMAT and the instructions for use provided on the other side of the leaflet. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer The marketing authorisation holder for SPIRIVA RESPIMAT is: Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein Germany The manufacturer for SPIRIVA RESPIMAT is: Boehringer Ingelheim Pharma GmbH & Co. KG Binger Straße 173 D-55216 Ingelheim am Rhein Germany This leaflet was last approved in 08/2009 2. BEFORE YOU TAKE SPIRIVA RESPIMAT Please read the following questions carefully. If you can answer any of these questions with 'Yes' please discuss this with your doctor before taking SPIRIVA RESPIMAT ­ are you allergic (hypersensitive) to tiotropium, atropine or similar drugs such as ipratropium or oxitropium?­ are you taking any other medicinal products containing ipratropium or oxitropium?­ are you pregnant, do you think you are pregnant, or are you breast-feeding?­ are you suffering from blurred vision, eye pain and / or red eyes, prostate problems or have difficulty passing urine? [. . . ] (half a turn) Prepare the SPIRIVA RESPIMAT inhaler for use by turning the clear base until it clicks. (half a turn) With the green cap closed, turn the base until it clicks. (half a turn) SPIRIVA RESPIMAT inhaler and the SPIRIVA RESPIMAT cartridge 2 Take the cartridge (H) out of the box. Push the narrow end of the cartridge into the inhaler until it clicks into place. [. . . ]