Quốc gia: Thụy Điển
Ngôn ngữ: Tiếng Thụy Điển
Nguồn: Läkemedelsverket (Medical Products Agency)
flutikasonpropionat; salmeterolxinafoat
Cipla Europe NV
R03AK06
fluticasone propionate; salmeterol
25 mikrogram/250 mikrogram/dos
Inhalationsspray, suspension
salmeterolxinafoat 36,32 mikrog Aktiv substans; flutikasonpropionat 250 mikrog Aktiv substans
Receptbelagt
Förpacknings: Spraybehållare, 10 x 120 doser (sjukhusförpackning); Spraybehållare, 2 x 120 doser; Spraybehållare, 3 x 120 doser; Spraybehållare, 120 doser
Godkänd
2016-12-22
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DUOHAL 25 MICROGRAMS /125 MICROGRAMS /DOSE PRESSURISED INHALATION, SUSPENSION DUOHAL 25 MICROGRAMS /250 MICROGRAMS /DOSE PRESSURISED INHALATION, SUSPENSION 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, pharmacist or nurse. - 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Duohal is and what it is used for 2. What you need to know before you use Duohal 3. How to use Duohal 4. Possible side effects 5. How to store Duohal 6. Contents of the pack and other information 1. WHAT DUOHAL IS AND WHAT IT IS USED FOR Duohal contains two medicines, salmeterol and fluticasone propionate: • Salmeterol is a long- acting bronchodilator. Bronchodilators help the airways in the lungs to stay open. This makes it easier for air to get in and out. The effects last for at least 12 hours. • Fluticasone propionate is a corticosteroid which reduces swelling and irritation in the lungs. The doctor has prescribed this medicine to help prevent breathing problems such as asthma. You must use Duohal every day as directed by your doctor. This will make sure that it works properly in controlling your asthma. Duohal helps to stop breathlessness and wheeziness coming on. However Duohal should not be used to relieve a sudden attack of breathlessness or wheezing. If that happens you need to use a fast acting ‘reliever’ (rescue) inhaler, such as salbutamol. You should always have your fast-acting ‘rescue’ inhaler with you. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE DUOHAL DO NOT TAKE DUOHAL: If you Đọc toàn bộ tài liệu
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Duohal 25 micrograms/125 micrograms /dose pressurised inhalation, suspension Duohal 25 micrograms/250 micrograms /dose pressurised inhalation, suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered dose of Duohal provides: 25 micrograms of salmeterol (as salmeterol xinafoate) and 125 or 250 micrograms of fluticasone propionate (delivered from the valve). This is equivalent to 21 micrograms of salmeterol and 110 or 220 micrograms of fluticasone propionate delivered from the actuator (delivered dose). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Pressurised inhalation, suspension. The canister contains a white homogeneous suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Duohal 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 corticosteroids and long-acting β 2 agonist. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Duohal is for inhalation use only. Patients should be made aware that Duohal must be used daily for optimum benefit, even when asymptomatic. Patients should be regularly reassessed by a doctor, so that the strength of Duohal they are receiving remains optimal and is only changed on medical advice. THE DOSE SHOULD BE TITRATED TO THE LOWEST DOSE AT WHICH EFFECTIVE CONTROL OF SYMPTOMS IS MAINTAINED. Where the control of symptoms is maintained with the lowest strength of Duohal (25/125 microgram), the next step could include a swap to a different inhaled salmeterol fluticasone product available in a lower strength (25/50 micrograms). As an alternative, patients requiring a long-acting β 2 agonist could be titrated to salmeterol/fluticasone propionate given once daily if, in the opinion of the prescriber, Đọc toàn bộ tài liệu