Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Cipla Europe NV
R03AK; R03AK06
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
25/250 microgram(s)
Pressurised inhalation, suspension
Product subject to prescription which may be renewed (B)
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; salmeterol and fluticasone
Not marketed
2017-03-10
1 0006a 30‐01‐17 Updated at Nat phase PACKAGE LEAFLET: INFORMATION FOR THE USER salmeterol/fluticasone propionate READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • KEEP THIS LEAFLET. YOU MAY NEED IT TO READ IT AGAIN. • IF YOU HAVE FURTHER QUESTIONS, PLEASE ASK YOUR DOCTOR OR YOUR PHARMACIST. • THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU PERSONALLY AND YOU SHOULD NOT PASS IT ON TO OTHERS. IT MAY HARM THEM, EVEN IF THEIR SYMPTOMS 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 Zoreeda is and what it is used for 2. What you need to know before you use Zoreeda 3. How to use Zoreeda 4. Possible side effects 5. How to store Zoreeda 6. Contents of the pack and other information 1. WHAT ZOREEDA IS AND WHAT IT IS USED FOR Zoreeda 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 Zoreeda every day as directed by your doctor. This will make sure that it works properly in controlling your asthma. ZOREEDA HELPS TO STOP BREATHLESSNESS AND WHEEZINESS COMING ON. HOWEVER, ZOREEDA 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ZOREEDA DO NOT TAKE ZOREEDA: If you are allergic (hypersensitive) to salmeterol, fluticasone propionate or to the other ingredient Izlasiet visu dokumentu
Health Products Regulatory Authority 19 November 2021 CRN00C6J0 Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zoreeda 25 microgram/250 microgram per actuation pressurised inhalation, suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered dose (ex valve) contains: 25 micrograms of salmeterol (as salmeterol xinafoate) and 250 micrograms of fluticasone propionate. This is equivalent to a delivered dose (ex actuator) of 21 micrograms of salmeterol and 220 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 rubine red (25 microgram/250 microgram) dust-caps. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ZOREEDA IS INDICATED FOR USE IN ADULTS WITH ASTHMA 18 YEARS OF AGE AND OLDER ONLY. Zoreeda is indicated in the regular treatment of patients with moderate to severe asthma where use of a combination product (long-acting β 2 agonist and inhaled corticosteroid) is appropriate: - patients not adequately controlled on a lower strength corticosteroid 'as needed' inhaled short-acting β 2 agonist. or - patients already adequately controlled on an inhaled corticosteroid in a mid or high strength and a long-acting β 2 agonist. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Zoreeda is indicated in adults 18 years of age and older only. Zoreeda is not indicated for use in children, 12 years of age or younger, or adolescents, 13 to 17 years of age. Posology Route of administration: Inhalation use. Patients should be made aware that Zoreeda must be used daily for optimum benefit, even when asymptomatic. Patients should be regularly reassessed by a doctor, so that the strength of Zoreeda 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 sy Izlasiet visu dokumentu