Prucalopride

Prucalopride is used to treat chronic idiopathic constipation (constipation without a known cause).

Prucalopride may also be used for reasons not mentioned in this medication guide.

Follow all instructions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You can take prucalopride with or without food.

Keep prucalopride in its original container at room temperature, away from moisture and heat.

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

You should not use prucalopride if you are allergic to it, 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.

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.

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

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

Prucalopride may cause serious side effects. Stop using prucalopride and call your doctor right away 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 side effects of prucalopride 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.

Usual Adult Dose for Chronic Idiopathic Constipation:

2 mg orally once a dayUse: Treatment of chronic idiopathic constipation (CIC)

Take the medicine as soon as possible, but if it is nearly time for your next dose, skip the missed dose. Do not take two doses at the same 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.

Other drugs may affect 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.