Patient Medication Information: uses, side effects, how to take - PMS-Prucalopride
ABOUT THIS MEDICATION
What the medication is used for:
Treatment of chronic constipation in adult females when laxatives do not provide adequate relief.
What it does:
pms-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 pms-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
pms-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: Cellulose Microcrystalline, Hypromellose, Isomalt, Macrogol, Magnesium Stearate, Silica Colloidal Anhydrous, Sodium Starch Glycolate, Talc, Titanium Dioxide.
2 mg: Cellulose Microcrystalline, Hypromellose, Indigo Carmine Aluminum Lake, Iron Oxide Red, Iron Oxide Yellow, Isomalt, Macrogol, Magnesium Stearate, Silica Colloidal Anhydrous, Sodium Starch Glycolate, Talc, Titanium Dioxide.
What dosage forms it comes in:
Tablets, 1 mg and 2 mg prucalopride, as prucalopride succinate
WARNINGS AND PRECAUTIONS
BEFORE you use pms-PRUCALOPRIDE talk to your doctor or pharmacist if:
You have any diseases affecting the liver, kidney,
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 prucalopride;
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.
INTERACTIONS WITH THIS MEDICATION
Drugs that may interact with pms-PRUCALOPRIDE include: ketoconazole, and erythromycin. Atropine-like substances may reduce the effect of pms-PRUCALOPRIDE.
PROPER USE OF THIS MEDICATION
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 pms-PRUCALOPRIDE treatment.
Overdose:
| If you have taken too much pms- 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.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, pms-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 pms-PRUCALOPRIDE and consult your doctor.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom/effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | ||
| Only if severe | In all cases | |||
| Common | Severe, persistent or bloody diarrhea or worsening abdominal symptoms (pain) | ✓ | ||
| Uncommon | Strong or irregular or racing heartbeat | ✓ | ||
| Chest pain | ✓ | |||
| Very Rare | Unusual changes in mood or behavior; Worsening depression, feeling sad or hopeless; Suicidal thoughts or actions about hurting or killing yourself | ✓ | ||
This is not a complete list of side effects. For any unexpected effects while taking pms-PRUCALOPRIDE, contact your doctor or pharmacist.
HOW TO STORE IT
pms-PRUCALOPRIDE should be kept out of the reach and sight of children. Store between 15- 30°C. Protect from moisture.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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 want more information about pms-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 Heath Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website www.pharmascience.com, or by calling 1-888-550-6060.
Pharmascience Inc.
Montréal, Québec
H4P 2T4 www.pharmascience.com
Last Approved: June 3, 2020