Prucalopride

Prucalopride is used to treat chronic idiopathic constipation (CIC; difficult or infrequent passage of stools that lasts for 3 months or longer and is not caused by a disease or a medication). Prucalopride is in a class of medications called serotonin receptor agonists. It works by increasing the movement of waste through the bowel.

Prucalopride comes as a tablet to take by mouth. It is usually taken with or without food once a day. Take prucalopride at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take prucalopride exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking prucalopride,

• tell your doctor and pharmacist if you are allergic to prucalopride, any other medications, or any of the ingredients in prucalopride tablets. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have a hole or blockage in your stomach or intestines or an inflammatory condition of the intestinal tract such as Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever), ulcerative colitis (condition that causes swelling and sores in the lining of the large intestine), or toxic megacolon or megarectum (life-threatening widening of the intestine or rectum). Your doctor will probably tell you not to take prucalopride.

• tell your doctor if you have or have ever had depression, suicidal thoughts or actions (thinking about harming or killing oneself or planning or trying to do so), or other mood problems, or kidney disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking prucalopride, call your doctor.

• you should know that your mental health may change in unexpected ways during treatment with prucalopride. You, your family, or your caregiver should call your doctor right away if you experience any of the following new symptoms or a worsening of these symptoms: depression; thinking about harming or killing yourself, or planning or trying to do so; or changes in mood or behavior. Be sure that your family or caregiver know these symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

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

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

• Prucalopride may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • headache

  • stomach pain

  • nausea

  • diarrhea

  • dizziness

• Some side effects can be serious. If you experience any of these symptoms or those listed in SPECIAL PRECAUTIONS section, stop taking prucalopride and call your doctor immediately or get emergency medical treatment:

  • difficulty breathing or shortness of breath

  • rash

  • itching

  • hives

  • swelling of face, lips, tongue, or throat

• Prucalopride may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

• If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• headache

• nausea

• diarrhea

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.