Kraj: Wielka Brytania
Język: angielski
Źródło: myHealthbox
salmeterol/fluticasone propionate
3M Health Care Ltd
R03AK06
salmeterol/fluticasone propionate
25microgram/125microgram
Pressurised inhalation, suspension
Inhalation
1x120 metered doses inhaler
POM - Prescription Only Medicine
3M Health Care Ltd
Adrenergics and other anti-asthmatics
is indicated in the regular treatment of asthma where use of a combination product (long-acting β2 agonist and inhaled corticosteroid) is appropriate
Authorised
2015-05-15
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ALOFLUTE 25 MICROGRAM/125 MICROGRAM PER METERED DOSE pressurised inhalation, suspension 25 MICROGRAM/250 MICROGRAM PER METERED DOSE pressurised inhalation, suspension salmeterol/fluticasone propionate 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 symptoms and 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. IN THIS LEAFLET 1. What Aloflute is and what it is used for 2. What you need to know before you use Aloflute 3. How to use Aloflute 4. Possible side effects 5. How to store Aloflute 6. Contents of the pack and other information 1. WHAT ALOFLUTE IS AND WHAT IT IS USED FOR Aloflute 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. ALOFLUTE IS INDICATED FOR USE IN ADULTS 18 YEARS OF AGE AND OLDER ONLY. ALOFLUTE IS NOT INDICATED FOR USE IN CHILDREN 12 YEARS OF AGE AND YOUNGER OR ADOLESCENTS 13 TO 17 YEARS OF AGE. The doctor has prescribed this medicine to help prevent breathing problems such as asthma. You must use Aloflute every day as directed by your doc Przeczytaj cały dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Aloflute 25 microgram/125 microgram per metered dose pressurised inhalation, suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered dose (ex valve) contains: 25 micrograms of salmeterol (as salmeterol xinafoate) and 125 micrograms of fluticasone propionate. This is equivalent to a delivered dose (ex actuator) of 21 micrograms of salmeterol and 110 micrograms of fluticasone propionate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Pressurised inhalation, suspension. The canister contains a white to off white suspension. The canisters are fitted into white plastic actuators incorporating an atomising orifice and fitted with mauve dustcaps. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Aloflute 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 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Aloflute is indicated in adults 18 years of age and older only. Aloflute is not indicated for use in children, 12 years of age and younger or adolescents, 13 to 17 years of age. Posology Route of administration: Inhalation use. Patients should be made aware that Aloflute must be used daily for optimum benefit, even when asymptomatic. Patients should be regularly reassessed by a doctor, so that the strength of Aloflute they are receiving remains optimal and is only changed on medical advice. THE DOSE SHOULD BE TITRATED TO THE LOWEST DOSE AT WHICH EFFECTIVE C Przeczytaj cały dokument