Motegrity is a serotonin-4 (5-HT4) receptor agonist used in the treatment of gastrointestinal disorders.

Motegrity is a prescription medicine used to treat chronic idiopathic constipation Idiopathic means without a known cause.

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

You should not use Motegrity if you have a blockage in your intestines, Crohn's disease, ulcerative colitis, or intestinal perforation.

Before taking this medicine

You should not use Motegrity if you are allergic to prucalopride, or if you have:

• a blockage in your intestines;

• severe constipation;

• inflammatory bowel disease (Crohn's disease, ulcerative colitis);

• toxic megacolon; or

• perforation (a hole or tear) of your intestines.

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

• kidney disease;

• depression;

• a mood disorder; or

• suicidal thoughts.

Tell your doctor if you are pregnant or breast-feeding.

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

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

You may take this medicine with or without food.

Store Motegrity in the original container at room temperature, away from moisture and heat.

Usual Adult Dose for Chronic Idiopathic Constipation:

2 mg orally once a day

Use: Treatment of chronic idiopathic constipation (CIC)

You should not use Motegrity if you are allergic to prucalopride, or if you have:

• a blockage in your intestines;

• severe constipation;

• inflammatory bowel disease (Crohn's disease, ulcerative colitis);

• toxic megacolon; or

• perforation (a hole or tear) of your intestines.

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

• kidney disease;

• depression;

• a mood disorder; or

• suicidal thoughts.

Tell your doctor if you are pregnant or breast-feeding.

Motegrity 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.

Overdose may cause severe diarrhea.

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 Motegrity: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

• unusual changes in mood or behavior;

• ongoing or worsening depression;

• thoughts about suicide or hurting yourself; or

• if you feel sad or hopeless.

Common Motegrity side effects may include:

• nausea, vomiting, diarrhea;

• stomach pain, bloating, gas;

• headache;

• dizziness; or

• feeling tired.

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.

Other drugs may interact with prucalopride, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.