Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Beclometasone dipropionate
GlaxoSmithKline (Ireland) Limited
R03BA; R03BA01
Beclometasone dipropionate
100 microgram(s)
Pressurised inhalation, solution
Product subject to prescription which may be renewed (B)
Glucocorticoids; beclometasone
Marketed
2005-01-07
Reason for Update: Ethanol Excipient update Market: IE Agency Approval Date: Text Date: 23/03/2022 Issue No.: 9 Draft No.: 1 1 PACKAGE LEAFLET: INFORMATION FOR THE USER BECOTIDE EVOHALER 50, 100 AND 250 MICROGRAMS Pressurised Inhalation Solution (Beclometasone dipropionate) 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 Becotide Evohaler is and what it is used for 2. What you need to know before you use Becotide Evohaler 3. How to use Becotide Evohaler 4. Possible side effects 5. How to store Becotide Evohaler 6. Contents of the pack and other information. 1. WHAT BECOTIDE EVOHALER IS AND WHAT IT IS USED FOR Becotide contains the active substance beclometasone dipropionate. Beclometasone dipropionate belongs to a group of medicines called corticosteroids (often just called steroids). A very small dose of steroid is needed when it is inhaled. This is because it is inhaled straight to your lungs. Becotide works by reducing swelling and irritation in the lungs. It has what is called an ‘anti-inflammatory action’. Becotide helps to prevent asthma attacks in people who need regular treatment. This is why it is sometimes called a 'preventer'. It needs to be used regularly, every day. Becotide will not help treat sudden asthma attacks where you feel breathless. • A different medicine is used for treating sudden attacks (called a ‘reliever’). • If you have more than one medicine, be careful not to confuse them. Becotide is supplied to you in an inhaler. You breathe the medicine di Přečtěte si celý dokument
Health Products Regulatory Authority 20 September 2022 CRN00CVH5 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Becotide Evohaler 100 micrograms, Pressurised Inhalation Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One metered dose contains 100 micrograms Beclometasone Dipropionate Excipient with known effect: One metered dose contains 7.64 mg of ethanol. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Pressurised Inhalation, Solution. Clear and colourless solution in an aluminium canister with a valve. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Severe asthma requires regular medical assessment as death may occur. Patients with severe asthma have constant symptoms and frequent exacerbations, with limited physical capacity, and PEF values below 60% predicted at baseline with greater than 30% variability, usually not returning entirely to normal after a bronchodilator. These patients will require high dose inhaled (see section 4.2) or oral corticosteroid therapy. Sudden worsening of symptoms may require increased corticosteroid dosage which should be administered under urgent medical supervision. _Adults:_ Prophylactic management in: Mild asthma (PEF values greater than 80% predicted at baseline with less than 20% variability): Patients requiring intermittent symptomatic bronchodilator asthma medication on more than an occasional basis. Moderate asthma (PEF values 60 - 80% predicted at baseline with 20 - 30% variability): Patients requiring regular asthma medication and patients with unstable or worsening asthma on other prophylactic therapy or bronchodilator alone. Severe asthma (PEF values less than 60% predicted at baseline with greater than 30% variability): Patients with severe chronic asthma. _Children:_ Children who require prophylactic asthma medication. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Becotide Evohaler is for oral inhalation use only. Patients should be made aware of the prophylactic nature of therapy with inhaled beclometasone Přečtěte si celý dokument