Details for: APO-PRUCALOPRIDE
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02491591 | APO-PRUCALOPRIDE | PRUCALOPRIDE (PRUCALOPRIDE SUCCINATE) | 1 MG | TABLET | ORAL |
| 02491605 | APO-PRUCALOPRIDE | PRUCALOPRIDE (PRUCALOPRIDE SUCCINATE) | 2 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Treatment of chronic constipation in adult females when laxatives do not provide adequate relief
What it does
APO-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 APOPRUCALOPRIDE (see What the non-medicinal 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
APO-PRUCALOPRIDE is not recommended in children younger than 18 years old.
What the medicinal ingredient is
Prucalopride succinate
What the non-medicinal ingredients are
1 mg prucalopride tablets:
hydroxypropyl cellulose, hydroxypropyl methylcellulose,
magnesium stearate, microcrystalline cellulose, titanium
dioxide, triethyl citrate
2 mg prucalopride tablets:
ferric oxide red, ferric oxide yellow, hydroxypropyl
cellulose, hydroxypropyl methylcellulose, magnesium
stearate, microcrystalline cellulose, titanium dioxide,
triethyl citrate
What dosage form it comes in
Tablets, 1 mg and 2 mg prucalopride, as prucalopride succinate
Warnings and precautions
BEFORE you use APO-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 succinate;
- 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 APO-PRUCALOPRIDE include: ketoconazole, and erythromycin. Atropinelike substances may reduce the effect of APOPRUCALOPRIDE.
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 APO-PRUCALOPRIDE treatment.
Overdose
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, APO-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 APOPRUCALOPRIDE and consult your doctor.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| 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 APO-PRUCALOPRIDE, contact your doctor or pharmacist.
How to store
APO-PRUCALOPRIDE should be kept out of the reach and sight of children. Store at room temperature 15°C30°C. Protect from moisture.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
If you want more information about APOPRUCALOPRIDE:
- 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://health-products.canada.ca/dpd-bdpp/index-eng.jsp). Find the Consumer Information on the manufacturer’s website http://www.apotex.ca/products, or by calling 1-800-667-4708.
Inc., Toronto, Ontario, M9L 1T9.
Last Prepared: August 15, 2019