国家: 马耳他
语言: 英文
来源: Medicines Authority
CICLESONIDE
Takeda GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Germany
R03BA08
CICLESONIDE 160 µg
PRESSURISED INHALATION, SOLUTION
CICLESONIDE 160 µg
POM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
Withdrawn
2009-12-15
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER ALVESCO 40, 80 AND 160 INHALER CICLESONIDE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET the information is arranged as follows: 1. What Alvesco is and what it is used for 2. Before you use Alvesco (This section contains important information for your safety) 3. How to use Alvesco 4. Possible side effects 5. How to store Alvesco 6. Further information 1. WHAT ALVESCO IS AND WHAT IT IS USED FOR WHAT ALVESCO IS: Alvesco is a clear and colourless 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. The ACTIVE INGREDIENT in this medicine is ciclesonide. (For the OTHER INGREDIENTS, see Section 6). WHAT ALVESCO IS USED FOR: This medicine is prescribed to control persistent asthma in adult and adolescent patients (12 years old and more). It 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. BEFORE YOU USE ALVESCO DO NOT USE A 阅读完整的文件
Page 1 of 8 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. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Pressurised inhalation, solution Clear and colourless 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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. 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. However in severe asthmatics, a 12 week study has shown that a dose of 640 micrograms/day (given 320 micrograms twice daily) has demonstrated a reduction in the frequency of exacerbations but without an improvement in lung function (see section 5.1). 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. 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. 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 阅读完整的文件