Jamp Prucalopride: Uses, Side Effects and Dosage

What the medication is used for:

Treatment of chronic constipation in adult females when laxatives do not provide adequate relief.

What it does:

JAMP Prucalopride increases the frequency of bowel movements to provide a feeling of complete evacuation by stimulating peristalsis, the muscular contractions of the gut needed for bowel movements.

When it should not be used:

• If you are allergic to any of the ingredients in JAMP Prucalopride (see What the nonmedicinal ingredients are)
• If you need dialysis
• If you have serious problems with your gut like blockages, holes in your intestine, Crohn’s disease or ulcerative colitis

JAMP Prucalopride is not recommended in children younger than 18 years old.

What the medicinal ingredient is:

Prucalopride succinate

What the nonmedicinal ingredients are:

• 1 mg prucalopride tablets:

Anhydrous colloidal silica, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, macrogol 400, polysorbate 80 and titanium dioxide.

• 2 mg prucalopride tablets:

  Anhydrous colloidal silica, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, macrogol 400, ploysorbate 80 and titanium dioxide.

What dosage forms it comes in:

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

and/or lung;

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

• You are using oral contraceptives for birth control;If you develop severe diarrhea, oral contraceptives may lose effectiveness and an additional method of contraception is recommended. Cases of unintended pregnancies have been reported for JAMP Prucalopride;

• If you have a rare hereditary problem of galactose intolerance, Lapp deficiency or glucose/galactose malabsorption, then you should not use JAMP Prucalopride as it contains lactose;

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

• You are pregnant, planning to become pregnant, breastfeeding or planning to breastfeed. Prucalopride is excreted in human breast milk.

Drugs that may interact with JAMP Prucalopride include: ketoconazole, and erythromycin. Atropine-like substances may reduce the effect of JAMP 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 doctor may increase the dose to 2 mg once daily if needed.

Patients with severe kidney impairment: 1 mg once daily.

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

Do not exceed a dosage of 2 mg per day. This will not add to the relief of constipation.

If there is no bowel movement in 3-4 days, contact your doctor. Your doctor may recommend an additional appropriate medication (e.g., laxative) for relief of immediate, acute constipation, at the same time as ongoing JAMP Prucalopride treatment.

Overdose:

BEFORE you use JAMP Prucalopride talk to your doctor or pharmacist if:

ABOUT THIS MEDICATION

INTERACTIONS WITH THIS MEDICATION

PROPER USE OF THIS MEDICATION

WARNINGS AND PRECAUTIONS

If you think you have taken too much JAMP Prucalopride, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Missed dose:

Do not double your dose. Take your regular dose when you remember.

Like all medicines, JAMP Prucalopride can cause side effects, although not everybody gets them. Please do not be alarmed by this list of side effects, you may not experience any of them.

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 common side effects include passing gas, enlargement of the abdomen or stomach, upset stomach, dizziness, tiredness, back pain, sinusitis, and kidney and urinary disorders.

Uncommon side effects include migraine and spinning sensation (vertigo)

Most of these side effects are mild to moderate in intensity. If you suffer 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 JAMP Prucalopride and consult your doctor.

This is not a complete list of side effects. For any unexpected effects while taking JAMP Prucalopride, contact your doctor or pharmacist.

JAMP Prucalopride should be kept out of the reach and sight of children. Store between 15- 30°C. Protect from moisture.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

HOW TO STORE IT

If you want more information about Jamp Prucalopride:

• Talk to your healthcare professional
• Find the full Product Monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada.html); or by contacting the sponsor, JAMP Pharma Corporation, at: 1-866-399-9091.

1310 rue Nobel, Boucherville, Québec, J4B 5H3

Last Prepared: October 28, 2019

REPORTING SIDE EFFECTS

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

MORE INFORMATION