Land: Storbritannien
Sprog: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Mirabegron
Astellas Pharma Ltd
G04BD12
Mirabegron
25mg
Modified-release tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 07040200; GTIN: 5013346075606
- Tell your doctor if you use dabigatran etexilate (a medicine which is used to reduce the risk of brain or body vessel obstruction by blood clot formation in adult patients with an abnormal heart beat (atrial fibrillation) and additional risk factors). This medicine may require dose adjustment by your doctor. PREGNANCY AND BREAST-FEEDING If you are pregnant, think you may be pregnant or are planning to have a baby you should not take Betmiga. If you are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine. It is likely that this medicine passes into your breast milk. You and your doctor should decide if you should take Betmiga or breast-feed. You should not do both. DRIVING AND USING MACHINES There is no information to suggest that this medicine affects your ability to drive or use machines. 3. HOW TO TAKE BETMIGA Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is one 50 mg tablet by mouth once daily. If you have kidney or liver problems, your doctor may need to reduce your dose to one 25 mg tablet by mouth once daily. You should take this medicine with liquids and swallow the tablet whole. Do not crush or chew the tablet. Betmiga can be taken with or without food. IF YOU TAKE MORE BETMIGA THAN YOU SHOULD If you have taken more tablets than you have been told to take, or if someone else accidentally takes your tablets, contact your doctor, pharmacist or hospital for advice immediately. Symptoms of overdose may include a forceful beating of the heart, an increased pulse rate or an increased blood pressure. IF YOU FORGET TO TAKE BETMIGA If you forget to take your medicine, take the missed dose as soon as you remember. If it is less than 6 hours before your next scheduled dose, skip the dose and continue to take your medicine at the usual time. Do not take a double dose to make up for a forgotten dose. If you miss several doses, tell your doctor and follow the advice given to you. IF YOU STO Læs hele dokumentet
OBJECT 1 BETMIGA 25MG PROLONGED-RELEASE TABLETS Summary of Product Characteristics Updated 25-Sep-2017 | Astellas Pharma Ltd 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). 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: GF Læs hele dokumentet