ประเทศ: อิสราเอล
ภาษา: อังกฤษ
แหล่งที่มา: Ministry of Health
MIRABEGRON
ASTELLAS PHARMA INTERNATIONAL B.V., ISRAEL
G04BD12
TABLETS PROLONGED RELEASE
MIRABEGRON 25 MG
PER OS
Required
ASTELLAS PHARMA EUROPE B.V, THE NETHERLANDS
MIRABEGRON
Symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome
2020-02-29
_This leaflet was checked and approved by the Ministry of Health on August 2016 and was updated _ _according to guidelines of the Ministry of Health in June 2019 _ PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor’s prescription only BETMIGA 50MG BETMIGA 25MG _ _ _PROLONGED-RELEASE _ _TABLETS _ _ _ _PROLONGED-RELEASE _ _TABLETS_ COMPOSITION: Each tablet of Betmiga 50mg contains: Mirabegron 50 mg. Each tablet of Betmiga 25mg contains: Mirabegron 25 mg. EXCIPIENTS - see section 6 "Additional Information" PLEASE READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, please ask the physician or the pharmacist. This medicine has been prescribed for the treatment of your ailment. Do not pass it on to others. It may harm them even if it seems to you that their ailment is similar. The medicine is not intended for children under the age of 18 as the safety and efficacy of Betmiga was not established in this age group. 1. WHAT IS THE MEDICINE INTENDED FOR? The medicine is meant for treatment of symptoms of an overactive bladder. THERAPEUTIC GROUP: Beta-3-adrenoreceptor agonist. 2. BEFORE USING THE MEDICINE. SPECIAL WARNINGS REGARDING USE OF THE MEDICINE: Consult your physician before starting of treatment: - If you have difficulties in emptying your bladder, if you have weak urine stream or if you take other medicines for the treatment of an overactive bladder such as anticholinergic medicines. DO NOT USE THE MEDICINE: - If you have hypersensitivity (allergy) to the active substance or any of the additional components which the medicine contains (see section 6). - if you have very high uncontrolled blood pressure - If you have abnormal liver or kidney functions. Your physician may need to reduce your dose or may guide you not to use the medicine, especially if you are taking other medicines, such as Itraconazole, Ketoconazole (fu อ่านเอกสารฉบับเต็ม
1 _ _ _The format of this leaflet was determined by the Ministry of Health and its content was checked and _ _approved in 08.2016. _ _The content of this leaflet was updated according to guidelines of the Ministry of Health in June 2019 _ 1. NAME OF THE MEDICINAL PRODUCT Betmiga 25 mg. Betmiga 50 mg. 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 prolonged-release tablets Oval, brown tablet, debossed with the company logo and “325” on the same side. Betmiga 50 mg prolonged-release 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). _ _ _ _ _ _ 2 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 Hep อ่านเอกสารฉบับเต็ม