Land: Sverige
Språk: svenska
Källa: Läkemedelsverket (Medical Products Agency)
ciklesonid
Medartuum AB
R03BA08
ciclesonide
160 mikrogram/dos
Inhalationsspray, lösning
ciklesonid 0,16 mg Aktiv substans; etanol, vattenfri Hjälpämne
Receptbelagt
Avregistrerad
2017-09-20
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER ALVESCO 80 AND 160 MCG INHALER CICLESONIDE 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 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Alvesco is and what it is used for 2. What you need to know before you use Alvesco 3. How to use Alvesco 4. Possible side effects 5. How to store Alvesco 6. Contents of the pack and other information 1. WHAT ALVESCO IS AND WHAT IT IS USED FOR WHAT ALVESCO IS: Alvesco is a clear and colorless aerosol spray for you to breathe in through your mouth and into your lungs. It is a Preventer medication (corticosteroid) that has to be taken every day and which becomes active only after it has been inhaled into your lungs. WHAT ALVESCO IS USED FOR: Alvesco is used to treat persistent asthma in adult and adolescent patients (12 years old and more). HOW ALVESCO WORKS Alvesco helps you to breathe more easily by decreasing the symptoms of your asthma and by lessening the chances of an asthma attack. The effect builds up over a period of time, so this medicine needs to be taken every day, even when you are feeling well. _THIS MEDICINE IS NOT SUITABLE FOR USE IN AN ACUTE ATTACK OF BREATHLESSNESS. FOR QUICK RELIEF FROM SUCH _ _AN ATTACK, USE ONLY YOUR RELIEVER INHALER. _ 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ALVESCO DO NOT USE ALVESCO if you are allergic to ciclesonide or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Alvesco. • BEFORE BEGINNING treatment with thi Läs hela dokumentet
1. NAME OF THE MEDICINAL PRODUCT Alvesco 160 Inhaler 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 actuation (delivered dose from the mouthpiece) contains 160 micrograms of ciclesonide. Excipient(s) with known effect: 1 actuation contains 4.7 mg of ethanol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Pressurised inhalation, solution Clear and colourless 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Alvesco is indicated in treatment to control persistent asthma in adults and adolescents (12 years and older). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The medicinal product is for inhalation use only. Posology Dosing recommendation for adults and adolescents: The recommended dose of Alvesco is 160 micrograms once daily, which leads to asthma control in the majority of patients. In patients with severe asthma and while reducing or discontinuing oral corticosteroids, a higher dose of up to 640mcg/day (given as 320mcg twice daily) may be used(see section 5.1). Patients should be given a dose of inhaled ciclesonide which is appropriate to the severity of their disease. Symptoms start to improve with Alvesco within 24 hours of treatment. Once control is achieved, the dose of Alvesco should be individualised and titrated to the minimum dose needed to maintain good asthma control.Dose reduction to 80 micrograms once daily may be an effective maintenance dose for some patients. Alvesco should preferably be administered in the evening although morning dosing of Alvesco has also been shown to be effective. The final decision on evening or morning dosing should be left to the discretion of the physician. Patients with severe asthma are at risk of acute attacks and should have regular assessments of their asthma control including pulmonary function tests. Increasing use of short-acting bronchodilators to relieve asthma symptoms indicates deterioration of asthma control. If patients find that short-acting relief bronchodilator treatment becomes less effective, or they need more inhalations than Läs hela dokumentet