Negara: Malta
Bahasa: Inggris
Sumber: Medicines Authority
BUDESONIDE
Orion Corporation Orionintie 1, FI-02200 Espoo, Finland
R03BA02
BUDESONIDE 100 µg
INHALATION POWDER
BUDESONIDE 100 µg
POM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
Licence number in the source country: NOT APPLICAPABLE
Authorised
2021-01-20
1 QR code to www.oeh.fi/bumt. See the end of this leaflet, scan this code or visit www.oeh.fi/bumt to see instructions on how to use Easyhaler PACKAGE LEAFLET: INFORMATION FOR THE USER GIONA EASYHALER 100 MICROGRAMS/DOSE INHALATION POWDER budesonide 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 or nurse. - This medicine has been prescribed for you only. Do 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Giona Easyhaler is and what it is used for 2. What you need to know before you use Giona Easyhaler 3. How to use Giona Easyhaler 4. Possible side effects 5. How to store Giona Easyhaler 6. Contents of the pack and other information 1. WHAT GIONA EASYHALER IS AND WHAT IT IS USED FOR The active ingredient in Giona Easyhaler is budesonide. Budesonide powder is packed in an inhaler. You inhale the powder into your lungs through the mouthpiece of the inhaler. Budesonide works by reducing and preventing swelling and inflammation in your lungs. Giona Easyhaler is a medicine called “ PREVENTER ”. It is used to prevent symptoms of asthma. It belongs to a group of medicines called corticosteroids. Page 2 of 10 Budesonide will NOT stop an asthma attack that has already started. Therefore you always need to have a fast acting bronchodilating “ RELIEVER” (a beta 2 -agonist) with you. The effect of budesonide may be noticable after a few days treatment but will only reach its maximum after a few weeks. You should use Giona Easyhaler regularly to prevent the asthmatic inflammation. Go on taking this medicine regularly according to instructions, even if you don’t have any symptoms. 2. WHAT YOU NEED T Baca dokumen lengkapnya
Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Giona Easyhaler 100 micrograms/dose inhalation powder. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One metered dose contains 100 micrograms of budesonide. With the Easyhaler device the delivered dose (ex-actuator) contains the same quantity of active substance as the metered dose (ex-reservoir). Excipient with known effect: Lactose monohydrate. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder. White or almost white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of mild, moderate, and severe persistent asthma. (Note: Giona Easyhaler is not suitable for the treatment of acute asthma attacks.) 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The therapeutic effect begins after a few days´ treatment and reaches its maximum after some weeks of treatment. When transferring a patient to Giona Easyhaler from other inhalation devices, the treatment should be individualised. The previous active substance, dose regimen, and method of delivery should be considered. The patients should be prescribed a starting dose of inhaled budesonide which is appropriate for the severity or level of control of their disease. The dose should be adjusted until control is achieved and then titrated to the lowest dose at which effective control of asthma is maintained. THE STARTING DOSE for adults (including the elderly and adolescents 12 to 17 years) with mild asthma (Step 2) and for children 6 to 11 years of age is 200-400 micrograms/day. If needed, the dose can be increased up to 800 micrograms/day. For adult patients with moderate (Step 3) and severe (Step 4) asthma the starting dose can be up to 1600 micrograms/day. The maintenance dose should be adjusted to meet the requirements of an individual patient taking into _ _ account the severity of the disease and the clinical response of the patient. Page 2 of 11 TWICE DAILY DOSING Adults with mild, moderate or severe asthma (including the elderly Baca dokumen lengkapnya