Țară: Suedia
Limbă: suedeză
Sursă: Läkemedelsverket (Medical Products Agency)
flutikasonpropionat
Cipla Europe NV
R03BA05
fluticasone propionate
250 mikrogram/dos
Inhalationsspray, suspension
flutikasonpropionat 250 mikrog Aktiv substans
Receptbelagt
Förpacknings: Inhalator, 120 doser; Inhalator, 2 x 120 doser; Inhalator, 3 x 120 doser; Inhalator, 10 x 120 doser (sjukhusförpackning)
Godkänd
2016-12-22
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ARQUIST 125 MICROGRAM PER ACTUATION PRESSURISED INHALATION, SUSPENSION ARQUIST 250 MICROGRAM PER ACTUATION PRESSURISED INHALATION, SUSPENSION 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Arquist is and what it is used for 2. What you need to know before you use Arquist 3. How to use Arquist 4. Possible side effects 5. How to store Arquist 6. Contents of the pack and other information 1. WHAT ARQUIST IS AND WHAT IT IS USED FOR This medicine contains the active substance fluticasone propionate which belongs to a group of medicines called corticosteroids. Arquist works by reducing inflammation in the lungs. This helps to prevent asthma attacks in people who need regular treatment. It takes 4-7 days for this medicine to work and it is very important that you use it regularly also when you do not have symptoms. Arquist is used for the regular treatment of asthma in adult and adolescents over 12 years of age. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ARQUIST DO NOT USE ARQUIST • if you are allergic to fluticasone propionate or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Stop using Arquist immediately • if you experience difficulty in breathing with immediate increase in wheezing just after taking a dose of this medicine. In this case, immediately use a short-acting bronchodilator inhaler. Talk to your doctor, pharmacist or nurse before using Arquist • if you Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Arquist 125 microgram per actuation pressurised inhalation, suspension Arquist 250 microgram per actuation pressurised inhalation, suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One metered dose (ex-valve) contains _ _ 125 or 250 micrograms of fluticasone propionate respectively. This is equivalent to a delivered dose (ex-actuator) of 110 microgram or 227 microgram fluticasone propionate respectively. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Pressurised inhalation, suspension An inhaler comprising a fluorocarbon polymer treated aluminium alloy canister, which is sealed with a metering valve, actuator and dust cap. 4. CLINICAL PARTICULARS 4.1THERAPEUTIC INDICATIONS Arquist is indicated for the regular treatment of asthma. Arquist is indicated in adult and adolescent patients over 12 years of age. 4.2POSOLOGY AND METHOD OF ADMINISTRATION Arquist is for oral inhalation use only. Patients should be made aware Arquist should be taken regularly even when they are asymptomatic. If patients find that relief with short-acting bronchodilator treatment becomes less effective or they need more inhalations than usual, medical attention must be sought. _Adult and adolescent patients over 12 years of age: _ 125 micrograms to 500 micrograms twice daily. The dose may be adjusted until control is achieved or reduced to the minimum effective dose, according to the individual response. Where the control of symptoms is maintained with the lowest strength of Arquist (125 microgram/actuation), the next step could include a swap to a different inhaled fluticasone product available in a lower strength (50 micrograms/actuation). The onset of therapeutic effect is within 4 to 7 days. For patients with severe asthma and during asthma exacerbations, as an alternative to oral corticosteroid therapy, a temporary increase in dose may be needed (up to 2000 micrograms daily in adult patients). The treatment effect should be monitored and fo Citiți documentul complet