What is MYRBETRIQ?

MYRBETRIQ is a prescription medicine for adults that can be used alone or with solifenacin succinate 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, when used alone or with solifenacin succinate, is safe and effective in children.

How should I take MYRBETRIQ?

• If your doctor prescribes MYRBETRIQ and solifenacin succinate together, you should take 1 MYRBETRIQ tablet and 1 solifenacin tablet at the same time, 1 time a day.
• You should take MYRBETRIQ with water and swallow the tablet whole.
• Do not chew, break, or crush the tablet.
• You can take MYRBETRIQ with or without food.
• You can take MYRBETRIQ and solifenacin succinate together with or without food.

The most common side effects of MYRBETRIQ, when used with solifenacin succinate, include:

• dry mouth
• urinary tract infection
• constipation
• fast heartbeat

USE OF MYRBETRIQ

Myrbetriq® (mirabegron) is a prescription medicine for adults that can be used alone or with solifenacin succinate to treat overactive bladder (OAB) with symptoms of urgency, frequency and leakage.

IMPORTANT SAFETY INFORMATION FOR MYRBETRIQ

Myrbetriq is not for everyone. Do not take Myrbetriq if you have an allergy to mirabegron or any ingredients in Myrbetriq. 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. Myrbetriq may increase your chances of not being able to empty your bladder. Tell your doctor right away if you have trouble emptying your bladder or you have a weak urine stream.

Myrbetriq may cause allergic reactions that may be serious. If you experience swelling of the face, lips, throat or tongue, with or without difficulty breathing, stop taking Myrbetriq and tell your doctor right away.

Tell your doctor about all the medicines you take including medications for overactive bladder or other medicines such as thioridazine (Mellaril™ and Mellaril-S™), flecainide (Tambocor®), propafenone (Rythmol®), digoxin (Lanoxin®), or solifenacin succinate (VESIcare®). Myrbetriq may affect the way other medicines work, and other medicines may affect how Myrbetriq works.

Before taking Myrbetriq, tell your doctor if you have liver or kidney problems. The most common side effects of Myrbetriq include increased blood pressure, common cold symptoms (nasopharyngitis), dry mouth, flu symptoms, urinary tract infection, back pain, dizziness, joint pain, headache, constipation, sinus irritation, and inflammation of the bladder (cystitis).

The most common side effects of MYRBETRIQ, when used with solifenacin succinate, include dry mouth, urinary tract infection, constipation, and fast heartbeat.

For further information, please talk to your healthcare professional and see accompanying Patient Product Information and complete Prescribing Information for Myrbetriq® (mirabegron).

USE OF VESICARE

VESIcare® (solifenacin succinate) is for overactive bladder with symptoms of urgency, frequency, and leakage.

IMPORTANT SAFETY INFORMATION FOR VESICARE

VESIcare is not for everyone. If you have certain stomach or glaucoma problems, or trouble emptying your bladder, do not take VESIcare. VESIcare may cause allergic reactions that may be serious. If you experience swelling of the face, lips, throat, or tongue, stop taking VESIcare and get emergency help. Tell your doctor right away if you have severe abdominal pain, or become constipated for three or more days. VESIcare may cause blurred vision, so use caution while driving or doing unsafe tasks. Common side effects are dry mouth, constipation, and indigestion.

For further information, please talk to your healthcare professional and see accompanying Patient Product Information and complete Prescribing Information for VESIcare® (solifenacin succinate).

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Myrbetriq® and VESIcare® are registered trademarks of Astellas Pharma Inc. All other trademarks or registered trademarks are the property of their respective owners.