Prucalopride belongs to the class of medications called prokinetic agents. This medication is used by adults experiencing chronic (long-term) constipation that is not caused by medications or another medical condition. Prucalopride is used after other laxatives have been tried and have not provided enough relief from the constipation.

Prucalopride works by increasing peristalsis (the rhythmic, wave-like muscle contractions needed for bowel movements) in the digestive system, thereby increasing the number of bowel movements.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

The recommended adult dose for prucalopride is 2 mg taken once a day. For seniors, the recommended starting dose is 1 mg taken once a day. If necessary, the dose may be increased to 2 mg once daily.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

If there has been no bowel movement after taking prucalopride for 3 or 4 days, contact your doctor. Your doctor may suggest adding a "rescue" laxative to be taken occasionally while you are taking prucalopride.

This medication may be taken with food or on an empty stomach. Try to take it at the same time each day.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Prucalopride should be kept in its original blister packaging to protect it from moisture. Store this medication at room temperature, and keep it out of the reach of children.

1 mg
Each white-to-off-white circular, film-coated tablet with “C” debossed on one side and “11” on the other side, contains 1 mg of prucalopride as prucalopride succinate. Nonmedicinal ingredients: anhydrous colloidal silica, lactose monohydrate, microcrystalline cellulose, and magnesium stearate; coating: hypromellose, titanium dioxide, macrogol 400, and polysorbate 80.

2 mg
Each pink, circular, film-coated tablet with “C” debossed on one side and “12” on the other side, contains 2 mg of prucalopride as prucalopride succinate. Nonmedicinal ingredients: anhydrous colloidal silica, lactose monohydrate, microcrystalline cellulose ,and magnesium stearate; coating: hypromellose, titanium dioxide, macrogol 400, iron oxide red, and polysorbate 80.

Do not take this medication if you:

• are allergic to prucalopride or any ingredients of this medication
• have kidney disease that requires dialysis
• have serious problems with your digestive system, such as a tear in the wall of the digestive system, a blockage in the digestive system, or inflammatory disease of the intestine such as Crohn's disease or ulcerative colitis
• have galactose intolerance or glucose malabsorption (a rare hereditary disease)

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal pain
• back pain
• diarrhea
• dizziness
• enlargement of abdomen or stomach
• headache
• gas
• nausea
• sinusitis
• tiredness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• abnormal heart rhythms (such as fast or slow heart rate, palpitations)
• chest pain
• migraine
• pounding, rapid heartbeat (palpitations)
• signs of depression (feeling sad, losing interest in things you used to enjoy, weight changes, changes in sleep habits, feelings of guilt or worthlessness, thoughts of suicide)
• signs of kidney problems (e.g., increased urination at night, decreased urine production, blood in the urine, change of urine colour)
• spinning sensation
• worsening digestive symptoms

Stop taking the medication and seek immediate medical attention if any of the following occur:

• severe diarrhea (watery; may also be bloody) or worsening abdominal pain
• thoughts of suicide or self harm

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Abnormal heart rhythm: Prucalopride has been shown to cause increased heart rate and may contribute to an irregular heartbeat. If you have a history of irregular heartbeat or ischemic heart disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Bowel inflammation: This medication may cause a potentially dangerous condition known as ischemic colitis. This occurs when not enough blood is reaching the walls of the colon. Symptoms include abdominal pain; severe, watery diarrhea that may be bloody; or bleeding from the rectum. If you notice these symptoms, stop taking prucalopride and seek immediate medical attention.

Drowsiness/reduced alertness: This medication may cause dizziness or tiredness when you first start to take it. Do not drive, operate machinery, or perform other hazardous tasks until you have determined how this medication affects you.

Liver function: There is very little information about how prucalopride is affected by reduced liver function. If you have liver problems or reduced liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you have severely reduced liver function you may need a lower dose.

Kidney function: Reduced kidney function or kidney disease may cause prucalopride to build up in the body, causing side effects. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

A lower-than-usual dose is recommended for people with severely reduced kidney function. If you have kidney disease that requires dialysis you should not take prucalopride.

Mental health: In clinical trials of people taking prucalopride there were reports of mood or behavior changes, including suicide. People taking this medication may experience changes in mood or behavior, worsening depression, or they may want to hurt themselves or others. If you experience these side effects or notice them in a family member who is taking this medication, contact your doctor immediately.

Pregnancy: There is not enough information available at this time to determine the safety and effectiveness of using prucalopride during pregnancy. This medication should be avoided by people who are pregnant.

People of childbearing age who are taking prucalopride should use an effective method of birth control (e.g., birth control pill, condoms) during treatment. If you experience severe diarrhea while taking certain types of birth control medications, they may not be as effective.

If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are breast-feeding and taking prucalopride, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children less than 18 years of age.

There may be an interaction between prucalopride and any of the following:

• aclidinium
• antihistamines (e.g., bilastine, cetirizine, doxylamine, diphenhydramine, hydroxyzine, ketotifen, loratadine, rupatadine)
• antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
• atropine
• benztropine
• birth control pills
• buprenorphine
• butorphanol
• clidinium
• darifenacin
• disopyramide
• estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)
• glycopyrrolate
• ipratropium
• methadone
• monoamine oxidase inhibitors (e.g., moclobemide, phenelzine, tranylcypromine)
• muscle relaxants (e.g., cyclobenzaprine, orphenadrine)
• narcotic pain relievers (e.g., codeine, fentanyl, hydromorphone, oxycodone, tramadol)
• oxybutynin
• pizotifen
• propiverine
• progestins (e.g., dienogest, levonorgestrel, medroxyprogesterone, norethindrone)
• scopolamine
• sirolimus
• solifenacin
• tiotropium
• tolterodine
• tricyclic antidepressants (e.g., amitriptyline, doxepin, nortriptyline)
• umeclidinium
• trospium

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.