NRA-Prucalopride: Uses, Side Effects and Dosage

What is NRA-PRUCALOPRIDE used for?

NRA-PRUCALOPRIDE is used to treat chronic constipation in adult females when laxatives do not work.

How does NRA-PRUCALOPRIDE work?

NRA-PRUCALOPRIDE increases the number of bowel movements by stimulating a process called peristalsis. Peristalsis is the muscular contractions of the gut needed for bowel movements.

What are the ingredients in NRA-PRUCALOPRIDE?

Medicinal Ingredients: Prucalopride succinate

Non-medicinal ingredients: Colloidal silicon dioxide, FD&C blue #2 aluminum lake (2 mg tablet), hypromellose, iron oxide red (2 mg tablet), iron oxide yellow (2 mg tablet), lactose monohydrate, magnesium stearate, microcrystalline cellulose, macrogol, titanium dioxide, and triacetin.

NRA-PRUCALOPRIDE comes in the following dosage forms:

Tablets, 1 mg and 2 mg prucalopride, as prucalopride succinate

Do not use NRA-PRUCALOPRIDE if:

• you are allergic to any of the ingredients in NRA-PRUCALOPRIDE (see What the nonmedicinal ingredients are)
• you need dialysis
• you have serious problems with your gut like blockages, holes in your intestine, Crohn’s disease ulcerative colitis or toxic megacolon/megarectum.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take NRA-PRUCALOPRIDE. Talk about any health conditions or problems you may have, including if you:

• have any diseases affecting your liver, kidney, or lung;
• have any neurological problems (these affect your nervous system) or suffer from psychiatric problems;
• have cancer, AIDS or endocrine disorders;
• have a history of abnormal heartbeat (arrhythmia) or any heart disease;
• have insulin-dependent diabetes;

• are using oral contraceptives for birth control; If you develop severe diarrhea, oral contraceptives may not work and an additional method of contraception is recommended. Cases of unintended pregnancies have been reported for NRA-PRUCALOPRIDE

• have a problem of galactose intolerance, Lapp deficiency or glucose/galactose malabsorption. If you have any of these you should not use NRA-PRUCALOPRIDE because as it contains lactose;

• are required to drive and use machines or other equipment;

• are pregnant, planning to become pregnant, breastfeeding or planning to breastfeed. NRA-PRUCALOPRIDE is excreted in human breast milk.

Other warnings you should know about

Stop taking NRA-PRUCALOPRIDE and tell your healthcare professional if you have:

• severe or persistent diarrhea
• severe, persistent or worsening abdominal symptoms
• bloody diarrhea or rectal bleeding

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with NRA-PRUCALOPRIDE:

• ketoconazole: used to treat fungus or yeast infections.
• erythromycin: used to manage and treat bacterial infections.
• Atropine-like substances: used to decrease mucus secretions such as saliva before anesthesia, to keep the heart beat normal during anesthesia and surgery, and to block or reverse the adverse effects caused by some medicines and certain type of pesticides.
• Verapamil: used to treat high blood pressure and to control angina
• cyclosporine A: used to treat organ rejection post-transplant
• Quinidine: used to treat irregular heartbeats
• Digoxin: used to treat heart failure and abnormal heart rhythms (arrhythmias)

How to take NRA-PRUCALOPRIDE:

Usual dose:

Adults (18 years of age and older): 2 mg once daily

Elderly (over 65 years of age): 1 mg once daily. Your healthcare professional may increase the dose to 2 mg once daily if needed.

Patients with severe kidney problems: 1 mg once daily.

Patients with severe liver problems: 1 mg once daily. Your healthcare may increase the dose to 2 mg once daily if needed.

Do not take more than 2 mg per day. This will not add to the relief of constipation.

If there is no bowel movement in 3-4 days, tell your healthcare professional. Your healthcare professional may tell you to take another medication (e.g., laxative) with NRA-PRUCALOPRIDE to help with the constipation.

NRA-PRUCALOPRIDE is not recommended in children younger than 18 years old.

Overdose:

Missed dose:

If you miss a dose of NRA-PRUCALOPRIDE, do not double your dose. Take your regular dose when you remember.

What are possible side effects from using NRA-PRUCALOPRIDE ?

These are not all the possible side effects you may have when taking NRA-PRUCALOPRIDE. If you experience any side effects not listed here, tell your healthcare professional.

The most common side effects include headache, stomach pain, nausea and diarrhea. These usually occur on the first day of treatment, and then go away within a day or so.

Other side effects include:

• pounding heart (palpitation)
• vomiting
• upper abdominal pain
• feeling of being slightly ill
• abnormal bowel sounds
• bleeding from anus (anal hemorrhage)
• muscle spasms
• excessive sweating
• frequent urination
• lack of blood
• high blood pressure
• vaginal hemorrhage
• gall stones and swelling of the gallbladder
• pancreas inflammation
• shortness of breath
• cystic ovarian mass
• passing gas
• enlargement of the abdomen or stomach
• upset stomach

If you think you, or a person you are caring for, have taken too much NRA-PRUCALOPRIDE, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

• dizziness
• tiredness
• back pain
• sinusitis
• kidney and urinary disorders.
• eating disorder with abnormally low body weight
• inflammation or swelling of the tissues lining your sinuses

Less common side effects include:

• migraine and spinning sensation (vertigo)
• fever
• loss of appetite
• migraine
• tremors
• anxiety
• loss of bladder control

Most of these side effects are mild to moderate in intensity.

If you have dizziness or tiredness, use caution in driving or operating machinery. In case of persistent, severe or bloody diarrhea, anal bleeding, or worsening abdominal symptoms, discontinue NRA-PRUCALOPRIDE and consult your doctor.

Serious side effects, what to do about them

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to the health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Storage:

Store between 15°C - 30°C. Protect from moisture. Store the tablets in the original blister package to protect from moisture

Keep out of the reach and sight of children.

If you want more information about NRA-PRUCALOPRIDE :

• Talk to your healthcare professional

• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health- canada/services/drugs-health-products/drug-products/drug-product-database.html ); the manufacturer’s website

  • or by calling 1-888-270-9874.

Last Revised: AUG 01, 2024