Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Beclometasone dipropionate anhydrous; Formoterol fumarate dihydrate
Chiesi Limited
R03AK; R03AK08
Beclometasone dipropionate anhydrous; Formoterol fumarate dihydrate
100/6 Mcg/Dose
Inhalation powder
Product subject to prescription which may be renewed (B)
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and beclometasone
Not marketed
2018-01-19
C ONFIDENTIAL CTD 1.3.1 1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FOSTAIR NEXTHALER 100 MICROGRAMS/6 MICROGRAMS PER METERED DOSE INHALATION POWDER FOR USE IN ADULTS beclometasone dipropionate anhydrous/formoterol fumarate dihydrate 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, nurse 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, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET 1. What Fostair Nexthaler is and what it is used for 2. What you need to know before you use Fostair Nexthaler 3. How to use Fostair Nexthaler 4. Possible side effects 5. How to store Fostair Nexthaler 6. Contents of the pack and other information 1. WHAT FOSTAIR NEXTHALER IS AND WHAT IT IS USED FOR Fostair Nexthaler is a powder that is inhaled through your mouth and delivered deeply into your lungs. It contains two active ingredients: beclometasone dipropionate anhydrous and formoterol fumarate dihydrate. - Beclometasone dipropionate belongs to a group of medicines called corticosteroids which have an anti-inflammatory action reducing the swelling and irritation in your lungs. - Formoterol fumarate dihydrate belongs to a group of medicines called long-acting bronchodilators. These relax the muscles in your airways, widening the airways so that it is easier for you to breathe air in and out of your lungs. These two active substances make breathing easier by providing relief from symptoms such as shortness of breath, wheezing and coughing in patients with asthma or COPD and also help to prevent asthma symptoms. ASTHMA Fostair Nexthaler is used to treat asthma in adults. If you are prescribed Fostair Nexthaler it is likely tha Læs hele dokumentet
Health Products Regulatory Authority 21 January 2019 CRN008JNW Page 1 of 24 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fostair Nexthaler 100 micrograms/6 micrograms per metered dose inhalation powder 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered dose of 10 mg inhalation powder contains: 100 micrograms of beclometasone dipropionate anhydrous and 6 micrograms of formoterol fumarate dihydrate. This is equivalent to a delivered dose (the dose leaving the mouthpiece) of 81.9 micrograms of beclometasone dipropionate anhydrous and 5.0 micrograms of formoterol fumarate dihydrate. Excipients with known effect: Each inhalation contains 9.9 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Inhalation powder. The multidose inhaler contains a white or almost white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ASTHMA Fostair Nexthaler is indicated in the regular treatment of asthma where use of a combination product (inhaled corticosteroid and long-acting beta 2 -agonist) is appropriate: - patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short-acting beta 2 -agonist or - patients already adequately controlled on both inhaled corticosteroids and long-acting beta 2 -agonists. Fostair Nexthaler is indicated for adult patients. COPD Health Products Regulatory Authority 21 January 2019 CRN008JNW Page 2 of 24 Symptomatic treatment of patients with severe COPD (FEV 1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Fostair Nexthaler is for inhalation use. ASTHMA Fostair Nexthaler is not intended for the initial management of asthma. The dosage of Fostair Nexthaler is individual and should be adjusted to the severity of the disease. This should be considered not only when treatment with combination products is initiated but also when the dose is adjusted. If an Læs hele dokumentet