Ülke: Malta
Dil: İngilizce
Kaynak: Medicines Authority
OLODATEROL, TIOTROPIUM BROMIDE
Boehringer Ingelheim International GmbH Binger Strasse 173, 55216 Ingelheim am Rhein, Germany
R03AL06
OLODATEROL 2.5 µg TIOTROPIUM BROMIDE 2.5 µg
INHALATION VAPOUR, SOLUTION
OLODATEROL 2.5 µg TIOTROPIUM BROMIDE 2.5 µg
POM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
Authorised
2015-06-24
Page 1 of 14 PACKAGE LEAFLET: INFORMATION FOR THE USER SPIOLTO RESPIMAT 2.5 MICROGRAM/2.5 MICROGRAM, INHALATION SOLUTION tiotropium/olodaterol 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 1. What Spiolto Respimat is and what it is used for 2. What you need to know before you take Spiolto Respimat 3. How to take Spiolto Respimat 4. Possible side effects 5. How to store Spiolto Respimat 6. Contents of the pack and other information 1. 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 relat Belgenin tamamını okuyun
Page 1 of 23 SUMMARY OF PRODUCT CHARACTERISTICS 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. Excipient with known effect: This medicine contains 0.0011 mg benzalkonium chloride in each actuation. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Inhalation solution Clear, colourless, inhalation solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Spiolto Respimat is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult 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 cartridge can only be inserted and used in the Respimat inhaler. Two puffs from the Respimat inhaler comprise one medicinal dose. _Adults _ The recommended dose is 5 microgram tiotropium and 5 microgram olodaterol given as two puffs from the Respimat inhaler once daily, at the same time of the day. The recommended dose should not be exceeded. _Elderly population _ Elderly patients can use Spiolto Respimat at the recommended dose. Page 2 of 23 _Hepatic impairment and Renal impairment _ Spiolto Respimat contains tiotropium which is a predominantly renally excreted drug and olodaterol, which is predominantly metabolized in the liver. _Hepatic impairment _ Patients with mild and moderate hepatic impairment can use Spiolto Respimat at the recommended dose. There are no data available for use of olodaterol in patients with severe hepatic impairment. _Renal impairment _ Renally impaired patients can use Spiolto Respimat at the recommended dose. For patients with moderate to severe impairment (creatinine clearance 50 ml/min) see 4.4 and 5.2. Spiolto Respimat co Belgenin tamamını okuyun