Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Mirabegron
Astellas Pharma Europe B.V.
G04BD12
mirabegron
Urologicals
Urinary Bladder, Overactive
Symptomatic treatment of urgency.Increased micturition frequency and / or urgency incontinence as may occur in adult patients with overactive-bladder syndrome.
Revision: 13
Authorised
2012-12-20
30 B. PACKAGE LEAFLET 31 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BETMIGA 25 MG PROLONGED-RELEASE TABLETS BETMIGA 50 MG PROLONGED-RELEASE TABLETS mirabegron 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Betmiga is and what it is used for 2. What you need to know before you take Betmiga 3. How to take Betmiga 4. Possible side effects 5. How to store Betmiga 6. Contents of the pack and other information 1. WHAT BETMIGA IS AND WHAT IT IS USED FOR Betmiga contains the active substance mirabegron. It is a bladder muscle relaxant (a so called beta 3-adrenoceptor agonist), which reduces the activity of an overactive bladder and treats the related symptoms. Betmiga is used to treat the symptoms of an overactive bladder in adults such as: - suddenly needing to empty your bladder (called urgency) - having to empty your bladder more than usual (called increased urinary frequency) - not being able to control when to empty your bladder (called urgency incontinence) 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BETMIGA DO NOT TAKE BETMIGA: - if you are allergic to mirabegron or any of the other ingredients of this medicine (listed in section 6) - if you have very high uncontrolled blood pressure. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Betmiga: - if you have trouble emptying your bladder or you have a weak urine stream or if you take other medicines for the treatment of overactive bladder such as anticholinergic medicines. - if you have kidney or liver problems. Your doctor m Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Betmiga 25 mg prolonged-release tablets Betmiga 50 mg prolonged-release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Betmiga 25 mg prolonged-release tablets Each tablet contains 25 mg of mirabegron. Betmiga 50 mg prolonged-release tablets Each tablet contains 50 mg of mirabegron. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release tablet. Betmiga 25 mg tablets Oval, brown tablet, debossed with the company logo and “325” on the same side. Betmiga 50 mg tablets Oval, yellow tablet, debossed with the company logo and “355” on the same side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults (including elderly patients)_ The recommended dose is 50 mg once daily _Special populations _ _Renal and hepatic impairment _ Betmiga has not been studied in patients with end stage renal disease (GFR < 15 mL/min/1.73 m 2 or patients requiring haemodialysis) or severe hepatic impairment (Child-Pugh Class C) and it is therefore not recommended for use in these patient populations (see sections 4.4 and 5.2). The following table provides the daily dosing recommendations for subjects with renal or hepatic impairment in the absence and presence of strong CYP3A inhibitors (see sections 4.4, 4.5 and 5.2). 3 TABLE 1: DAILY DOSING RECOMMENDATIONS FOR SUBJECTS WITH RENAL OR HEPATIC IMPAIRMENT IN THE ABSENCE AND PRESENCE OF STRONG CYP3A INHIBITORS Strong CYP3A inhibitors (3) Without inhibitor With inhibitor Renal impairment (1) Mild 50 mg 25 mg Moderate 50 mg 25 mg Severe 25 mg Not recommended Hepatic impairment (2) Mild 50 mg 25 mg Moderate 25 mg Not recommended 1. Mild: GFR 60 to 89 mL/min/1.73 m 2 ; moderate: GFR 30 to 59 mL/min/1.73 m 2 ; severe: GFR 15 to 29 mL/min/1.73 m 2 . 2. Mild Прочетете целия документ