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BetmigaTM (mirabegron) Presentation: BetmigaTM


Prescribing Information prolonged-release


film-coated tablets containing 25mg or 50mg mirabegron. Indication: Symptomatic treatment of


urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome. Dosage: Adults (including the elderly):


Recommended dose: 50mg once daily. Children and adolescents: Should not be used. Contraindications: Hypersensitivity to active substance or any of the excipients. Severe uncontrolled hypertension. Warnings and Precautions: Should not be used in patients with end stage renal disease (or patients requiring haemodialysis) or severe hepatic impairment. Not recommended in patients with severe renal impairment and/or moderate hepatic impairment concomitantly receiving strong CYP3A inhibitors. Dose adjustment to 25mg is recommended in patients with; mild/moderate renal and/or mild hepatic impairment receiving strong CYP3A inhibitor concomitantly and in patients with severe renal and/or moderate hepatic impairment. Mirabegron can increase blood pressure. Blood pressure should be measured at baseline and periodically during treatment, especially in hypertensive patients. Caution in patients with a known history of QT prolongation or in patients taking medicines known to prolong the QT interval. Use with caution in patients with clinically significant bladder outlet obstruction (BOO) and in patients taking antimuscarinics for OAB. Not recommended during pregnancy and in women of childbearing potential not using contraception. Not recommended during breastfeeding. Interactions: Clinically relevant drug interactions between BetmigaTM


and medicinal products that inhibit, induce or are a substrate for


one of the CYP isozymes or transporters are not expected, except for inhibitory effect on the metabolism of CYP2D6 substrates. BetmigaTM


is a moderate and


time-dependent inhibitor of CYP2D6 and weak inhibitor of CYP3A. No dose adjustment needed when administered with CYP2D6 inhibitors or CYP2D6 poor metabolisers. Caution if co-administered with medicines with a narrow therapeutic index and significantly metabolised by CYP2D6. When initiating in combination with digoxin, the lowest dose for digoxin should be prescribed and serum digoxin should be monitored and used for titration of digoxin dose. Substances that are inducers of CYP3A or P-gp decrease the plasma concentrations of BetmigaTM


. No dose adjustment is needed for BetmigaTM


when administered with therapeutic doses for rifampicin or other CYP3A or P-gp inducers. The potential for inhibition of P-gp by BetmigaTM


should


be considered when combined with sensitive P-gp substrates. Increases in mirabegron exposure due to drug-drug interactions may be associated with increases in pulse rate. Adverse Effects: Urinary tract infection, tachycardia, nausea, vaginal infection, cystitis, palpitation, atrial fibrillation, dyspepsia, gastritis, urticaria, rash, rash macular, rash papular, pruritus, joint swelling, vulvovaginal pruritus, blood pressure increase, liver enzymes increase, eyelid oedema, lip oedema, leukocytoclastic vasculitis, purpura, angioedema, urinary retention and insomnia. Prescribers should consult the Summary of Product Characteristics in relation to other side effects. Pack and prices: BetmigaTM


25mg and BetmigaTM


Legal Category: POM. Product Licence Number: BetmigaTM EU/1/12/809/001 – 007; BetmigaTM


50mg pack of 30 tablets £29.00. 25mg


50mg EU/1/12/809/008 –


014. Date of Preparation: September 2015. Further information available from: Astellas Pharma Ltd, 2000 Hillswood Drive, Chertsey, Surrey, KT16 0RS, UK. BetmigaTM


is a Registered Trademark. For


full prescribing information please refer to the Summary of Product Characteristics. For Medical Information phone 0800 783 5018.


Adverse events should be reported. Reporting forms and information can be found at


www.mhra.gov.uk/yellowcard Adverse events should also be reported to Astellas Pharma Ltd. Please contact 0800 783 5018


References: 1. Betmiga Summary of Product Characteristics, September 2015. 2. Astellas data on file, BET15124UK. July 2015.


Date of preparation: November 2015 Approval code: BET15152UK(1)d


t


CARRY ON PATIENT.


Prescribe Betmiga for OAB and patients are more likely to stay on the treatment they need than if you choose an antimuscarinic.1,2


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