Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
TIOTROPIUM BROMIDE MONOHYDRATE
Boehringer Ingelheim International GmbH
R03BB04
TIOTROPIUM BROMIDE MONOHYDRATE
18 Microgram
Inhalation Powder, Capsule
Product subject to prescription which may be renewed (B)
Anticholinergics
Authorised
2015-08-13
F1/IE/MT/PI/2 1 PACKAGE LEAFLET: INFORMATION FOR THE USER FAVYND 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 Favynd 18 microgram is and what it is used for 2. What you need to know before you use Favynd 18 microgram 3. How to use Favynd 18 microgram 4. Possible side effects 5. How to store Favynd 18 microgram 6. Contents of the pack and other information 1. WHAT FAVYND 18 MICROGRAM IS AND WHAT IT IS USED FOR Favynd 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 use Favynd 18 microgram every day and not only when you have breathing problems or other symptoms of COPD. Favynd 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 Favynd 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 Favynd 18 microgram will also help to prevent sudden, short-term worsening of your COPD symptoms which Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Favynd 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: Each capsule contains approximately 5.5 milligrams of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Inhalation powder, hard capsule. Light green hard capsules containing the inhalation powder,with the product code TI 01 and company logo printed on the capsule. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tiotropium is indicated as a maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease (COPD). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The medicinal product is intended for inhalation use only. The recommended dosage of tiotropium bromide is inhalation of the contents of one capsule once daily with the HandiHaler device at the same time of day. The recommended dose should not be exceeded. Tiotropium bromide capsules are only for inhalation and not for oral intake. Tiotropium bromide capsules must not be swallowed. Tiotropium bromide should only be inhaled with the HandiHaler device. Special populations Geriatric patients can use tiotropium bromide at the recommended dose. Renally impaired patients can use tiotropium bromide at the recommended dose. For patients with moderate to severe impairment (creatinine clearance 50 ml/min) see section 4.4 and section 5.2. Hepatically impaired patients can use tiotropium bromide at the recommended dose (see section 5.2). Paediatric Lees het volledige document