Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Fannin Limited
R03AK; R03AK06
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
25/250 microgram(s)/dose
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
Marketed
2017-03-10
1 0008a 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. Sereflo 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 Sereflo every day as directed by your doctor. This will make sure that it works properly in controlling your asthma. SEREFLO HELPS TO STOP BREATHLESSNESS AND WHEEZINESS COMING ON. HOWEVER, SEREFLO 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. DO NOT TAKE SEREFLO: If you are allergic (hypersensitive) to salmeterol, fluticasone propionate or to the other ingredient norflurane (HFA134a). WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR BEFORE USING SEREFLO IF YOU HAVE: • Heart disease, including an irregular or fast heart beat • Overactive thyroid gland • High blood pressure • Diabetes mellitus (Sereflo may increase your blood sugar) SEREFLO 25MICROGRAM/125 MICROGRAM PER ACTUATION PRESSURISED INHALATION, SUSPENS Baca dokumen lengkap
Health Products Regulatory Authority 24 October 2019 CRN0091GM Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sereflo 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 dust-caps. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS SEREFLO IS INDICATED FOR USE IN ADULTS WITH ASTHMA 18 YEARS OF AGE AND OLDER ONLY. Sereflo 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 combination product or patients already adequately controlled on an inhaled corticosteroidin a mid or high strength and a long-acting β 2 agonist. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Sereflo is indicated in adults 18 years of age and older only. Sereflo 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 Sereflo must be used daily for optimum benefit, even when asymptomatic. Patients should be regularly reassessed by a doctor, so that the strength of Sereflo 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. NOTE: Sereflo is only available Baca dokumen lengkap