Gemtesa is a selective beta-3 adrenergic agonist that affects the muscles in the bladder.

Gemtesa is used in adults to treat the symptoms of overactive bladder.

Gemtesa helps improve:

• urge urinary incontinence: a strong need to urinate with leaking or wetting accidents:
• urgency: the need to urinate right away: and
• frequency: urinating often.

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

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Use Gemtesa exactly as prescribed by your doctor. Follow all directions on your prescription label and use the medicines exactly as directed. Follow all directions on your prescription label and read all medication guides or instruction sheets.

The normal dose of Gemtesa is one 75mg tablet, taken by mouth, once daily.

Take this medicine with a full glass of water.

You may take Gemtesa with or without food.

If you cannot swallow a tablet whole, you may crush the tablet and mix it with 1 tablespoon of applesauce. Swallow the mixture right away with a glass of water. Do not save the mixture for later use.

Store at room temperature away from moisture and heat.

Do not keep leftover Gemtesa. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, mix the leftover medicine with cat litter or coffee grounds in a sealed plastic bag throw the bag in the trash.

Usual Adult Dose for Overactive Bladder Syndrome:

75 mg orally once a day

Use: For the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults

You should not use Gemtesa if you are allergic to vibegron.

To make sure Gemtesa is safe for you, tell your doctor if you have ever had:

• trouble emptying your bladder;

• a weak stream of urine;

• liver disease; or

• kidney disease.

Tell your doctor if you are pregnant or breastfeeding.

Gemtesa is not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

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

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

Get emergency medical help if you have signs of an allergic reaction to Gemtesa: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if:

• you are unable to completely empty your bladder; or

• you have pain or burning when you urinate.

Common Gemtesa side effects may include:

• painful urination;

• nausea, diarrhea;

• headache; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

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 or digitalis.

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