Details for: BIO-DOMPERIDONE
Company: BIOMED PHARMA
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02445034 | BIO-DOMPERIDONE | DOMPERIDONE (DOMPERIDONE MALEATE) | 10 MG | TABLET | ORAL |
Summary Reports
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
BIO-DOMPERIDONE is used to treat symptoms of slowed stomach emptying seen in people with some gastrointestinal disorders (e.g. gastritis- inflammation of the GI tract). BIO-DOMPERIDONE is also used to reduce symptoms such as nausea and vomiting caused by some drugs used to treat Parkinson’s disease.
What it does
BIO-DOMPERIDONE increases the mild digestive contractions of the esophagus and stomach and helps to more effectively coordinate the emptying of food from the stomach into the intestine. It also helps to more effectively move digesting food material through the small intestine
When it should not be used
It should not be used in patients who are known to be allergic to domperidone or any of the nonmedicinal ingredients (See What the nonmedicinal ingredients are). It should not be used in patients who show signs of bleeding in the stomach or intestines, or who may have an obstruction or perforation of the stomach or intestines.
It should not be used in patients who have a tumour associated with the pituitary gland known as a prolactinoma.
Do not use BIO-DOMPERIDONE if you have:
- moderate or severe liver problems
- heart disease including congestive heart failure or prolonged QT interval
- prolactinemia (a pituitary tumour releasing prolactin)
- electrolyte imbalance (unbalanced levels of salts) in your blood
- are taking certain drugs listed in the Interactions section of this consumer information
What the medicinal ingredient is
Domperidone Maleate
What the non-medicinal ingredients are
Colloidal silicon dioxide, croscarmellose sodium, fumaric acid, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, and Opadry White (contains polyethylene glycol, titanium dioxide and hypromellose).
What dosage form it comes in
BIO-DOMPERIDONE is available as 10 mg domperidone tablets (as domperidone maleate).
Warnings and precautions
Serious Warnings and Precautions
BIO-DOMPERIDONE may be associated with an increased risk of heart rhythm disorder and sudden death (cardiac arrest). This risk may be more likely in those over 60 years old or taking doses higher than 30 mg per day. Domperidone should be used at the lowest possible dose for the shortest duration necessary.
- The maximum dosage is one 10 mg tablet three times daily, to help avoid adverse heart effects.
- For patients at risk for heart problems, your doctor may request an assessment of your heart function (e.g. EEG) before and/or during domperidone treatment.
BEFORE you use BIO-DOMPERIDONE talk to your doctor or pharmacist if:
- you have, or have ever had breast cancer
- you have an irregular heartbeat, or any other kind of heart disease
- you have any kind of kidney disease
- you are pregnant of plan to become pregnant
- you are breastfeeding or planning to breastfeed. Domperidone is excreted in breast milk. Discuss with your doctor.
- you experience any kind of unusual discharge of breast milk
- you are a male and have any kind of irregular growth of the breasts
- you are taking any other medications (See Interactions with this medication)
Interactions with this medication
Do not take BIO-DOMPERIDONE with the following drugs as they are contraindicated:
- antiarrhymics (drugs for the heart) including disopyramide, quinidine, hydroquinidine, amiodarone, dofetilide, dronedarone, sotalol)
- certain antidepressants (e.g. citalopram, escitalopram)
- certain antibiotics (e.g. erythromycin, clarithromycin, levofloxacin, moxifloxacin, spiramycin, telitromycin)
- certain antifungal agents (e.g. pentamidine)
- certain antimalarial agents (e.g. halofantrine, lumefantrine)
- certain gastrointestinal agents (e.g. cisapride, dolasetron, prucalopride)
- certain antihistamines (e.g. mequitazine, mizolastine)
- certain cancer medicines (e.g. toremifene, vandetanib, vincamine)
- some other medications (e.g. bepridil, methadone, diphemanil)
- do not take BIO-DOMPERIDONE with grapefruit juice
Drugs that may interact with BIO- DOMPERIDONE include:
- a drug called ketoconazole
- any kind of drug known as:
- an “anticholinergic” drug
- an antifungal drug
- an antibiotic drug
- a drug to treat AIDS
- a drug called nefazodone
Proper use of this medication
Usual Adult Dose
For disorders involving movement of food through the stomach and intestines: one 10 mg tablet taken 3 times per day, 15 to 30 minutes before meals.
Overdose
Symptoms of overdosage may include drowsiness, disorientation, difficulty with normal body movements, irregular heartbeat and lowered blood pressure.
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Side effects and what to do about them
Most side effects will gradually disappear with continuing administration of BIO-DOMPERIDONE and are easily tolerated. The more serious or troublesome side effects are dose related and gradually resolve after the dose is lowered or if administration of the drug is discontinued.
Common side effects include dry mouth, headache and migraine. Uncommon side effects include abdominal cramps, diarrhea, regurgitation (bring up stomach contents), nausea and rash. If these side effects become troublesome, talk to your doctor.
Contact your doctor if more serious or troublesome side effects occur such as galactorrhea (excessive or spontaneous flow of breast milk), gynecomastia (excessive development of male mammary gland) or menstrual irregularities (spotting or delayed periods).
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Uncommon | |||
| palpitations | ✔ | ||
| irregular heart beat (arrhythmia) | ✔ | ||
| dizziness | ✔ | ||
| fainting | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking BIO-DOMPERIDONE, contact your doctor or pharmacist.
How to store
Store between 15-30°C. Protect from light and moisture.
Keep out of the reach and sight of children.
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 3 ways:
- Report online at 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, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available at 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
This document plus the full product monograph, prepared for health professionals can be found by contacting Biomed Pharma at 1-888-731-6703 or info@biomed-pharma.ca.
This leaflet was prepared by
Biomed Pharma
Last Revised: September 25, 2020