Details for: TEVA-DOMPERIDONE
Company: TEVA CANADA LIMITED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 01912070 | TEVA-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
TEVA-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). TEVA-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
TEVA-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
In 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 ratio-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
Cornstarch, croscarmelose sodium, hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium docusate 85%-sodium benzoate 15% and, titanium dioxide, triacetin.
What dosage form it comes in
TEVA-DOMPERIDONE is available as 10 mg domperidone tablets (as domperidone maleate).
Warnings and precautions
Serious Warnings and Precautions
TEVA-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 TEVA-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 or plan to become pregnant
- you are breast feeding 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 TEVA-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 ratio-Domperidone with grapefruit juice
Drugs that may interact with TEVA-DOMPERIDONE include:
- a drug called ketoconazole
- any kind of drug known as:
- an “anticholinergic” drug
- an antifungal drug
- an antibiotic drug
- a drug t
- 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.
Side effects and what to do about them
Most side effects will gradually disappear with continuing administration of ratio-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 the 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 with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| Uncommon | |||
| palpitations | ✔ | ||
| irregular heart beat (arrhythmia) | ✔ | ||
| dizziness | ✔ | ||
| fainting | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking TEVA-DOMPERIDONE, contact your doctor or pharmacist.
How to store
Keep out of the reach and sight of children.
Store between 15-30°C. Protect from light.
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 (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
This document plus the full product monograph, prepared for health professionals can be found by contacting Teva Canada Limited by:
Phone: 1-800-268-4127 ext. 3;
Email: druginfo@tevacanada.com; or
Fax: 1-416-335-4472
This leaflet was prepared by:
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
www.tevacanada.com
Last revised: April 11, 2018