Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Beclometasone dipropionate anhydrous; Formoterol fumarate dihydrate
Chiesi Farmaceutici S.p.A.
R03AK; R03AK08
Beclometasone dipropionate anhydrous; Formoterol fumarate dihydrate
200/6 Mcg/Acutuation
Inhalation powder
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and beclometasone
Not marketed
2018-04-13
C ONFIDENTIAL CTD 1.3.1 1.3.1 PL 0873 2021-04 1 CHF 1535 NEXTHALER ® 200 ΜG /6 ΜG PER INHALATION INHALATION POWDER PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FOSTAIR NEXTHALER 200 MICROGRAMS/6 MICROGRAMS PER INHALATION INHALATION POWDER For use in adults beclometasone dipropionate anhydrous/formoterol fumarate dihydrate 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, 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. See section 4. 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 substances: beclometasone dipropionate anhydrous and formoterol fumarate dihydrate. - Beclometasone dipropionate belongs to a group of medicines called corticosteroids which gave 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. They also help to prevent asthma symptoms, such as shortness of breath, wheezing and coughing. Fostair Nexthaler is used to treat asthma in adults. If you are prescribed Read the complete document
Health Products Regulatory Authority 25 September 2020 CRN009D4Y Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fostair Nexthaler 200 micrograms/6 micrograms per metered dose inhalation powder 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered dose of 10 mg inhalation powder contains: 200 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 158.8 micrograms of beclometasone dipropionate anhydrous and 4.9 micrograms of formoterol fumarate dihydrate. Excipient with known effect: Each metered dose contains 9.8 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 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 in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 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 individual patient should require a combination of doses other than those available in the combination inhaler, appropriate doses of beta 2 -agonists and/or corticosteroids by individual inhalers should be prescribed. Because of its extrafine particle size distribution, dose adjustment is required when patients are transferred to Fostair Nexth Read the complete document