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

Prucalopride may also be used for purposes not listed in this medication guide.

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

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

You may take prucalopride with or without food.

Store prucalopride 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 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.

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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

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

Prucalopride may cause serious side effects. Stop using prucalopride 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 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.

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.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.