Myrbetriq relaxes the muscles of the urinary bladder, reducing bladder spasms. It is used alone or with solifenacin succinate to treat the symptoms of overactive bladder, such as frequent or urgent urination and urinary incontinence.

Myrbetriq is used in adults to treat overactive bladder with symptoms of frequent or urgent urination and urinary incontinence. It is sometimes used together with another medicine called solifenacin (Vesicare).

Myrbetriq is used in children to treat neurogenic detrusor overactivity (NDO). Urinary incontinence caused by NDO is related to permanent nerve damage from conditions such as multiple sclerosis or spinal injury.

Myrbetriq tablets may be used in children at least 3 years old. Myrbetriq granules are for use in children at least 3 years old who also weigh at least 77 pounds (35 kilograms).

You should not use Myrbetriq if you have

• end stage renal disease (kidney failure)
• severe kidney disease; or
• severe uncontrolled high blood pressure.

A condition called angioedema can occur after taking Myrbetriq. Angioedema is a condition that leads to face, lip, tongue, throat swelling, difficulty breathing and can be fatal. Seek emergency attention immediately if these symptoms occur.

It may take up to 8 weeks before your symptoms improve. Keep using this medicine as directed and tell your doctor if your symptoms do not improve after 8 weeks of treatment.

Before taking this medicine

You should not use Myrbetriq if you are allergic to mirabegron.

To make sure this medicine is safe for you, tell your doctor if you have:

• high blood pressure;

• a bladder obstruction;

• trouble emptying your bladder (very little urine or a weak stream of urine);

• kidney disease; or

• liver disease.

Tell your doctor if you are pregnant or breastfeeding.

Myrbetriq should not be given to a child younger than 3 years old.

Take Myrbetriq exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

If you take Myrbetriq with solifenacin, take both medicines at the same time each day.

Take the Myrbetriq tablet with a full glass of water. Swallow the tablet whole and do not crush, chew, or break it.

An adult may take a Myrbetriq tablet with or without food. However, a child should take the tablet with food.

Both adults and children should take Myrbetriq granules with food.

A pharmacist will mix the granules into a suspension (liquid) before you receive the medicine.

Shake the suspension before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

If the suspension will not be used for 2 days or longer, shake the bottle vigorously for 1 minute each day to keep the granules thoroughly mixed.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Your dose needs may change if you switch from using tablets to using the suspension. Avoid medication errors by using only the form and strength your doctor prescribes.

Your blood pressure will need to be checked often.

It may take up to 8 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Store at room temperature away from moisture and heat. Throw away any unused Myrbetriq suspension after the expiration date on the medicine label has passed.

You should not use Myrbetriq if you are allergic to mirabegron.

To make sure this medicine is safe for you, tell your doctor if you have:

• high blood pressure;

• a bladder obstruction;

• trouble emptying your bladder (very little urine or a weak stream of urine);

• kidney disease; or

• liver disease.

Tell your doctor if you are pregnant or breastfeeding.

Myrbetriq should not be given to a child younger than 3 years old.

Use the medicine as soon as you can, but skip the missed dose if you are more than 12 hours late for the dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose may cause pounding heartbeats or fluttering in your chest.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Stop using Myrbetriq and get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• pain or burning when you urinate; or

• dangerously high blood pressure - severe headache, blurred vision, pounding in your neck or ears.

Common Myrbetriq side effects may include:

• painful urination;

• increased blood pressure;

• sinus pain, sore throat;

• constipation;

• headache; or

• dry mouth or fast heartbeats (when taken with solifenacin).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• digoxin;

• flecainide;

• propafenone;

• solifenacin; or

• thioridazine.

This list is not complete. Other drugs may interact with mirabegron, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.