Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CICLESONIDE
DKSH MALAYSIA SDN BHD
CICLESONIDE
1Units Units
Kindeva Drug Delivery Limited
_Consumer Medication Information Leaflet (RiMUP) _ ALVESCO INHALER Ciclesonide (80mcg/actuation, 160mcg/actuation) 1 WHAT IS IN THIS LEAFLET 1. What Alvesco is used for 2. How Alvesco works 3. Before you use Alvesco 4. How to use Alvesco 5. While you are using it 6. Side Effects 7. Storage and Disposal of Alvesco 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT ALVESCO IS USED FOR Alvesco is a preventer medication in the treatment of asthma that has to be taken everyday and which becomes active only after it has been inhaled into your lungs. HOW ALVESCO WORKS Alvesco contains the active ingredient ciclesonide. Ciclesonide belongs to a group of medicines called corticosteroid. Alvesco is prescribed to control persistent asthma in adult, adolescents and children over 6 years. 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. BEFORE YOU USE ALVESCO _-_ _When you must not use it_ You should not take Alvesco if you: • Are allergic to ciclesonide or any of the other ingredients of this medicine. (see section PRODUCT DESCRIPTION). • Are pregnant or plan to become pregnant. Consult your doctor first, as he/she will consider the risk and benefit of you taking Alvesco if you are pregnant. • Are breast-feeding or plan to breastfeed. It is not known if Alvesco passes into your breast milk. You and your doctor should decide if you will take Alvesco or breastfeed. You should not do both without first talking with your doctor. _-_ _Before you start to use it_ Before you take Alvesco, tells your doctor if you: • Have ever been treated, or are currently being treated, for pulmonary tuberculosis (TB), fungal, viral or bacterial infections • Have severe asthma. Alvesco is not indicated in the treatment of severe or acute episodes of asthma. If you have severe asthma, your doctor Baca dokumen lengkap
PRESENTATIONS ALVESCO ® 80 mcg inhaler is a metered-dose inhaler which delivers 80 micrograms of ciclesonide per actuation. ALVESCO ® 160 mcg Inhaler is a metered-dose inhaler which delivers 160 micrograms of ciclesonide per actuation. INDICATIONS Alvesco ® is indicated as prophylactic treatment of asthma in adults, adolescents and children over 6 years. DOSAGE AND ADMINISTRATION The recommended dose range for adults, elderly patients and adolescents over 12 years of age with mild to moderate asthma is 160 to 640 mcg per day. In severe asthma, this dose range may be increased to 1280 mcg per day. The recommended dose range for children over 6 years is 80 mcg to 160 mcg per day. For once daily dosing, Alvesco ® should preferably be administered in the evening although morning dosing of Alvesco ® has also been shown to be effective. The final decision on morning or evening 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 individualized and titrated to the minimum dose needed to maintain good asthma control. Alvesco ® can be used with or without a spacer (i.e., AeroChamber Plus TM ). Specific patient groups: There is no need to adjust the dose in elderly patients or those with hepatic or renal impairment. Adolescent and adult patients taking chronic oral corticosteroid therapy: When transferring a patient from an oral steroid to Alvesco ® , the patient should be in a relatively stable phase. A high dose of Alvesco ® should be given in combination with the oral steroid for about 10 days. Then the oral steroid should be gradually reduced no faster than 2.5 mg/day on a weekly basis to the lowest possible level. INSTRUCTIONS FOR USE/HANDLING Patients need to be instructed how to use the inhaler correctly. If the inhaler is new or has not been used for one week or more, three puffs should be released into the air. No shaking is necessary as this is a solution aerosol. Instruc Baca dokumen lengkap