Ülke: Avustralya
Dil: İngilizce
Kaynak: Department of Health (Therapeutic Goods Administration)
mirabegron, Quantity: 25 mg
Astellas Pharma Australia Pty Ltd
Mirabegron
Tablet, modified release
Excipient Ingredients: butylated hydroxytoluene; magnesium stearate; hyprolose; purified water; macrogol 2000000; macrogol 8000; hypromellose; iron oxide yellow; iron oxide red
Oral
10, 20, 30, 60, 90, 200
(S4) Prescription Only Medicine
Symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence in patients with overactive bladder (OAB) syndrome.
Visual Identification: Oval, brown film-coated tablet, debossed with "325" and the Astellas logo; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius
Licence status A
2013-10-17
BETMIGA ® B E T M I G A ® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING BETMIGA? BETMIGA contains mirabegron, a beta 3-adrenoceptor agonist, which is used to treat symptoms of an overactive bladder. For more information, see Section 1. Why am I using BETMIGA? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE BETMIGA? Do not use if you have ever had an allergic reaction to BETMIGA or any of the ingredients listed at the end of the CMI. Do not take BETMIGA if you have very high blood pressure (systolic greater than or equal to 180mmHg and /or diastolic greater than or equal to 110mmHg). For more information, see Section 2. What should I know before I use BETMIGA? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with BETMIGA and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE BETMIGA? • The usual dose is 25 mg tablet once a day. Based upon your response and tolerability, your doctor may increase your dose to 50 mg once daily. The maximum dose for BETMIGA is 50 mg once daily. More instructions can be found in Section 4. How do I use BETMIGA? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING BETMIGA? THINGS YOU SHOULD DO • If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking BETMIGA. • Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine. • If you become pregnant while taking this medicine, tell your doctor immediately. • Keep all of your doctor's appointments so that your progress can be checked. THINGS YOU SHOULD NOT DO • Do not take BETMIGA to treat any other complaints unless your doctor tells you to. • Do not give your medicine to anyone else, even if they have the same condition as you. • Do not stop taking your medicine or alter t Belgenin tamamını okuyun
1 AUSTRALIAN PRODUCT INFORMATION – BETMIGA ® (MIRABEGRON) PROLONGED-RELEASE FILM-COATED TABLETS 1 NAME OF THE MEDICINE Mirabegron 2 QUALITATIVE AND QUANTITATIVE COMPOSITION BETMIGA contains mirabegron 25 mg or 50 mg as the active ingredient. For the full list of excipients, see Section 6.1 - LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM BETMIGA is available as prolonged-release film-coated tablets for oral administration. The tablets are presented as the following: 25 mg: an oval, brown film-coated tablet, debossed with the (Astellas logo) and “325” 50 mg: an oval, yellow film-coated tablet, debossed with the (Astellas logo) and “355” 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence in patients with overactive bladder (OAB) syndrome. 4.2 D OSE AND METHOD OF ADMINISTRATION Adults (including Elderly Patients) The recommended starting dose of BETMIGA is 25 mg once daily. Based on individual patient efficacy and tolerability the dose may be increased to 50 mg once daily. BETMIGA can be taken with or without food. The tablet should be taken with liquids, swallowed whole and is not to be chewed, divided, or crushed. Patients with Renal Impairment No dose adjustment is necessary in patients with mild or moderate renal impairment (eGFR 30 to 89 mL/min/1.73 m2 as estimated by MDRD). In patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73 m2), the recommended dose is 25 mg once daily with or without food. BETMIGA has not been studied in patients with End Stage Renal Disease (eGFR <15 mL/min/1.73 m2 or patients requiring haemodialysis) (see Section 5.2 - PHARMACOKINETIC PROPERTIES - Pharmacokinetic Characteristics in Special Populations). Patients with Hepatic Impairment No dose adjustment is necessary in patients with mild hepatic impairment (Child-Pugh Class A). In patients with moderate hepatic impairment (Child-Pugh Class B) the recommended dose is 25 mg once daily with or without food. BETMIGA has not bee Belgenin tamamını okuyun