Land: Sverige
Språk: svenska
Källa: Läkemedelsverket (Medical Products Agency)
flutikasonpropionat; salmeterolxinafoat
Sandoz A/S
R03AK06
fluticasone propionate; salmeterol
50 mikrogram/500 mikrogram
Inhalationspulver, avdelad dos
salmeterolxinafoat 73 mikrog Aktiv substans; flutikasonpropionat 500 mikrog Aktiv substans; laktosmonohydrat Hjälpämne
Apotek
Receptbelagt
Salmeterol och flutikason
Förpacknings: Inhalator, 1 x 60 doser
Avregistrerad
2015-03-12
PACKAGE LEAFLET: INFORMATION FOR THE USER Lastenol Forspiro, 50 microgram/500 microgram/dose, inhalation powder, predispensed SALMETEROL/FLUTICASONE PROPIONATE 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 Lastenol Forspiro is and what it is used for 2. What you need to know before you use Lastenol Forspiro 3. How to use Lastenol Forspiro 4. Possible side effects 5. How to store Lastenol Forspiro 6. Contents of the pack and other information 1. WHAT LASTENOL FORSPIRO IS AND WHAT IT IS USED FOR Lastenol Forspiro is used to treat: asthma chronic obstructive pulmonary disease (COPD) This disease is characterized by continuous breathing difficulties caused by narrowed airways, often accompanied with coughing and phlegm. This medicine reduces the number of flare ups of COPD symptoms. This medicine contains two active substances. Salmeterol: a long-acting substance that widens the airways Fluticasone: a corticosteroid which reduces swelling and inflammation in the lungs 2. WHAT YOU NEED TO KNOW BEFORE YOU USE LASTENOL FORSPIRO DO NOT USE LASTENOL FORSPIRO if you are ALLERGIC to salmeterol, fluticasone or to the other ingredient of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Lastenol Forspiro if you have: heart disease, including an irregular or fast heartbeat overactive thyroid gland high blood pressure diabetes mellitus low potassium in your blood tuberculosis now or in the past, or o Läs hela dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Lastenol Forspiro, 50 microgram/500 microgram/dose, inhalation powder, predispensed 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered dose of Lastenol Forspiro provides: For 50 microgram/500 microgram/dose, inhalation powder, predispensed: 50 micrograms of salmeterol (as salmeterol xinafoate) and 500 micrograms of fluticasone propionate Corresponding with a delivered dose of: 45 micrograms of Salmeterol (as salmeterol xinafoate) and 465 micrograms of fluticasone propionate Excipient with known effect: lactose monohydrate: 11.95 mg per metered dose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder, pre-dispensed. White, homogenous powder The pre-dispensed powder, contained in blister, is delivered by a purple plastic dry-powder inhalation device. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ASTHMA_ Lastenol Forspiro is indicated in the regular treatment of asthma where use of a combination product (long-acting β 2 agonist and inhaled corticosteroid) is appropriate: patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short acting β 2 agonist or patients already adequately controlled on both inhaled corticosteroid and long-acting β 2 agonist. _CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)_ Lastenol Forspiro is indicated for the symptomatic treatment of patients with COPD, with a FEV 1 <60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Method of administration: Lastenol Forspiro is for inhalation use only. Patients should be made aware that Lastenol Forspiro must be used daily for optimum benefit, even when asymptomatic. Patients should be regularly reassessed by a doctor, so that the strength of Lastenol Forspiro they are receiving remains optimal and is only changed on medical advice. THE DOSE SHOULD BE T Läs hela dokumentet