Myr­be­triq® (mirabegron) ex­tended-re­lease tablets 25 mg, 50 mg Brief Sum­mary based on Fda-ap­proved pa­tient la­bel­ing

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Read the Pa­tient In­for­ma­tion that comes with Myr­be­triq® (mirabegron) be­fore you start tak­ing it and each time you get a re­fill. There may be new in­for­ma­tion. This sum­mary does not take the place of talk­ing with your doc­tor about your med­i­cal con­di­tion or treat­ment.

What is Myr­be­triq (meer-beh-trick)?

Myr­be­triq is a pre­scrip­tion med­i­ca­tion for adults used to treat the fol­low­ing symp­toms due to a con­di­tion called over­ac­tive blad­der:

• urge uri­nary in­con­ti­nence: a strong need to uri­nate with leak­ing or wet­ting ac­ci­dents

• ur­gency: a strong need to uri­nate right away

• fre­quency: uri­nat­ing of­ten

It is not known if Myr­be­triq is safe and ef­fec­tive in chil­dren.

Who should not use Myr­be­triq?

'o not use Myr­be­triq if you have an al­lergy to mirabegron or any of the in­gre­di­ents in Myr­be­triq. See the end of this leaflet for a com­plete list of in­gre­di­ents in Myr­be­triq.

What is over­ac­tive blad­der?

Over­ac­tive blad­der oc­curs when you can­not con­trol your blad­der con­trac­tions. When these mus­cle con­trac­tions hap­pen too of­ten or can­not be con­trolled, you can get symp­toms of over­ac­tive blad­der, which are uri­nary fre­quency, uri­nary ur­gency, and uri­nary in­con­ti­nence (leak­age).

What should I tell my doc­tor be­fore tak­ing Myr­be­triq?

Be­fore you take Myr­be­triq, tell your doc­tor if you:

• have liver prob­lems or kid­ney prob­lems

• have very high un­con­trolled blood pres­sure

• have trou­ble emp­ty­ing your blad­der or you have a weak urine stream

• are preg­nant or plan to be­come preg­nant. It is not known if Myr­be­triq will harm your un­born baby.

Talk to your doc­tor if you are preg­nant or plan to be­come preg­nant.

• are breast­feed­ing or plan to breast­feed. It is not known if Myr­be­triq passes into your breast milk. You

and your doc­tor should de­cide if you will take Myr­be­triq or breast­feed. You should not do both.

Tell your doc­tor about all the medicines you take, in­clud­ing pre­scrip­tion and non­pre­scrip­tion medicines, vi­ta­mins, and herbal sup­ple­ments. Myr­be­triq may af­fect the way other medicines work, and other medicines may af­fect how Myr­be­triq works.

Tell your doc­tor if you take:

• thior­i­dazine (Mel­laril™ or Mel­laril-s™)

• fle­cainide (Tam­bo­cor®)

• propafenone (Ryth­mol®)

• digoxin (Lanoxin®)

How should I take Myr­be­triq?

• Take Myr­be­triq ex­actly as your doc­tor tells you to take it.

• You should take 1 Myr­be­triq tablet 1 time a day.

• You should take Myr­be­triq with water and swal­low the tablet whole.

• 'o not crush or chew the tablet.

• You can take Myr­be­triq with or with­out food.

• If you miss a dose of Myr­be­triq, be­gin tak­ing Myr­be­triq again the next day. 'o not take 2 doses of Myr­be­triq the same day.

If you take too much Myr­be­triq, call your doc­tor or go to the near­est hos­pi­tal emer­gency room right away.

What are the pos­si­ble side ef­fects of Myr­be­triq?

Myr­be­triq may cause se­ri­ous side ef­fects in­clud­ing:

• in­creased blood pres­sure. Myr­be­triq may cause your blood pres­sure to in­crease or make your blood pres­sure worse if you have a his­tory of high blood pres­sure. It is rec­om­mended that your doc­tor check your blood pres­sure while you are tak­ing Myr­be­triq. •

• in­abil­ity to empty your blad­der (uri­nary retention). Myr­be­triq may in­crease your chances of not be­ing able to empty your blad­der if you have blad­der out­let ob­struc­tion or if you are tak­ing other medicines to treat over­ac­tive blad­der. Tell your doc­tor right away if you are un­able to empty your blad­der.

an­gioedema. Myr­be­triq may cause an al­ler­gic re­ac­tion with swelling of the lips, face, tongue, throat with or with­out dif­fi­culty breath­ing. Stop us­ing Myr­be­triq and tell your doc­tor right away.

The most com­mon side ef­fects of Myr­be­triq in­clude:

• in­creased blood pres­sure

• com­mon cold symp­toms (na­sopharyn­gi­tis)

• uri­nary tract in­fec­tion

• con­sti­pa­tion

• di­ar­rhea

• dizzi­ness

• headache

Tell your doc­tor if you have any side ef­fect that both­ers you or that does not go away or if you have swelling of the face, lips, tongue, or throat, hives, skin rash or itch­ing while tak­ing Myr­be­triq.

These are not all the pos­si­ble side ef­fects of Myr­be­triq.

For more in­for­ma­tion, ask your doc­tor or phar­ma­cist.

Call your doc­tor for med­i­cal ad­vice about side ef­fects. You may re­port side ef­fects to the FDA at 1-800-FDA-1088.

How should I store Myr­be­triq?

• Store Myr­be­triq be­tween F to F (1 C to C). Keep the bot­tle closed.

• Safely throw away medicine that is out of date or no longer needed.

Keep Myr­be­triq and all medicines out of the reach of chil­dren.

Gen­eral in­for­ma­tion about the safe and ef­fec­tive use of Myr­be­triq

Medicines are some­times pre­scribed for pur­poses other than those listed in the Pa­tient In­for­ma­tion leaflet. 'o not use Myr­be­triq for a con­di­tion for which it was not pre­scribed. 'o not give Myr­be­triq to other peo­ple, even if they have the same symp­toms you have. It may harm them.

Where can I go for more in­for­ma­tion?

This is a sum­mary of the most im­por­tant in­for­ma­tion about Myr­be­triq. If you would like more in­for­ma­tion, talk with your doc­tor. You can ask your doc­tor or phar­ma­cist for in­for­ma­tion about Myr­be­triq that is writ­ten for health pro­fes­sion­als.

For more in­for­ma­tion, visit www.myr­be­ or call ( ) 2 - .

What are the in­gre­di­ents in Myr­be­triq?

Ac­tive in­gre­di­ent: mirabegron

In­ac­tive in­gre­di­ents: poly­eth­yl­ene ox­ide, poly­eth­yl­ene gly­col, hy­drox­ypropyl cel­lu­lose, buty­lated hy­drox­y­toluene, mag­ne­sium stearate, hypromel­lose, yel­low fer­ric ox­ide and red fer­ric ox­ide (2 mg Myr­be­triq tablet only).

Rx Only

PRO'UCT OF -APAN OR IRE­LAN' – See bot­tle la­bel or blis­ter pack­age for ori­gin

Mar­keted and Dis­trib­uted by:

Astel­las Pharma US, Inc.

North­brook, Illi­nois 2 • Myr­be­triq® is a reg­is­tered trade­mark of Astel­las Pharma Inc. All other trade­marks or reg­is­tered trade­marks are the prop­erty of their re­spec­tive own­ers.

2 1 Astel­las Pharma US, Inc.

Re­vised: Au­gust 2 1


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