Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
Salmeterol; Fluticasone propionate
Glenmark Pharmaceuticals Nordic AB
R03AK06
Salmeterol; Fluticasone propionate
50/500 microgram(s)
Inhalation powder, pre-dispensed
salmeterol and fluticasone
2019-02-08
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT STALPEX 50 MICROGRAM/500 MICROGRAM/DOSE INHALATION POWDER, PRE-DISPENSED 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 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 Stalpex is and what it is used for 2. What you need to know before you use Stalpex 3. How to use Stalpex 4. Possible side effects 5. How to store Stalpex 6. Contents of the pack and other information 1. WHAT STALPEX IS AND WHAT IT IS USED FOR Stalpex 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 • Chronic Obstructive Pulmonary Disease (COPD), reduces the number of flare ups of COPD symptoms. You must use Stalpex every day as directed by your doctor. This will make sure that it works properly in controlling your asthma or COPD. STALPEX HELPS TO STOP BREATHLESSNESS AND WHEEZINESS COMING ON. HOWEVER STALPEX SHOULD NOT BE USED TO RELIEVE A SUDDEN ATTACK OF BREATHLESSNESS OR WHEEZING. IF THIS 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. STALPEX SHOULD ONLY BE USED TO TREAT ASTHMA Διαβάστε το πλήρες έγγραφο
Health Products Regulatory Authority 23 August 2023 CRN00DP1G Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Stalpex 50 microgram/500 microgram/dose inhalation powder, pre-dispensed 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 47 micrograms of salmeterol (as salmeterol xinafoate) and 460 micrograms of fluticasone propionate. This corresponds to a pre-dispensed dose of 50 micrograms of salmeterol (as salmeterol xinafoate) and 500 micrograms fluticasone propionate. Excipient(s) with known effect: Each dose contains lactose up to 12.9 milligram. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Inhalation powder, pre-dispensed. Molded plastic inhaler containing a foil strip with 60 regularly placed blisters. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Asthma_ STALPEX IS INDICATED FOR USE IN PATIENTS WITH SEVERE ASTHMA 12 YEARS OF AGE AND OLDER ONLY. Stalpex is indicated in the regular treatment of patients with SEVERE asthma where use of a combination product (long-acting β2 agonist and inhaled corticosteroid) is appropriate: - patients not adequately controlled on a lower strength corticosteroid combination product or - patients already adequately controlled on an inhaled corticosteroid in a high strength and a long-acting β2 agonist. _Chronic Obstructive Pulmonary Disease (COPD)_ Stalpex is indicated for the symptomatic treatment of patients with COPD, with a FEV 1 <60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Stalpex is indicated in adults and adolescents 12 years of age and older only. Stalpex is not indicated for use in children younger than 12 years of age. Posology Route of administration: Inhalation use. Patients should be made aware that Stalpex must be used daily for optimum benefit, even when asymptomatic. Patie Διαβάστε το πλήρες έγγραφο