Patient Medication Information: uses, side effects, how to take - Riva-Ondansetron
ABOUT THIS MEDICATION
What the medication is used for:
The name of your medicine is RIVA-ONDANSETRON Tablets (Ondansetron hydrochloride). This medicine is one of a group called antiemetics.
RIVA-ONDANSETRON is used for:
- the prevention of nausea (feeling of sickness) and vomiting associated with emetogenic chemotherapy, and radiotherapy.
- the prevention and treatment of post-operative nausea and vomiting.
What it does:
Treatments such as general anaesthesia, cancer chemotherapy and radiotherapy are thought to cause the release of a natural substance (serotonin), which can cause you to feel sick and to vomit. RIVA-ONDANSETRON helps to stop this from happening, thus preventing you from vomiting or feeling sick.
When it should not be used:
Do not take RIVA-ONDANSETRON if:
- you have a history of hypersensitivity (an allergic reaction) to any ingredient in RIVA-ONDANSETRON
you are pregnant, or likely to become pregnant, or if you are breast feeding a baby. However, there may be circumstances when your doctor advises you to use this medicine during pregnancy.
What the medicinal ingredients:
RIVA-ONDANSETRON tablets contain ondansetrn hydrochloride as the medicinal ingredient.
What the important non-medicinal ingredients are:
RIVA-ONDANSETRON Tablets contain the following non-medicinal ingredients: lactose, microcrystalline cellulose, pregelatinized starch, magnesium stearate, methyl hydroxypropyl cellulose, triacetin, iron oxide yellow and titanium dioxide.
What dosage forms it comes in:
RIVA-ONDANSETRON tablets are supplied in two strengths, one contains 4 milligrams of ondansetron and the other contains 8 milligrams of ondansetron. Your doctor will decide which strength you need.
WARNINGS AND PRECAUTIONS:
BEFORE you use RIVA-ONDANSETRON talk to your doctor or pharmacist if:
- you have a history of hypersensitivity (an allergic reaction) to any ingredient in RIVA-ONDANSETRON
- you are pregnant or likely to become pregnant.
- you are breast feeding a baby.
- you have liver problems.
- you have signs of intestinal obstruction.
- you have a history of heart problems
If you experience wheezing and tightness of the chest, heart throbbing, swelling of eyelids, face or lips, or develop a skin rash, skin lumps or hives, contact your doctor immediately. Do not take anymore medicine unless your doctor tells you to do so.
INTERACTIONS WITH THIS MEDICATION
I
It is important that your doctor knows about all your medication so that you get the best possible treatment. Tell your doctor about all the medicines you are taking including those you have bought yourself. If you are taking any medicines containing tramadol (such as TRAMACET), RIVA-ONDANSETRON may decrease its effectiveness.
PROPER USE OF THIS MEDICATION
The label on the container of your medicine should tell you how often to take your medicine and how many doses you should take each time. If not, or if you are not sure, consult your doctor or pharmacist.
Do not take more doses, or take them more often than your doctor prescribes. If, however, you vomit within one hour of taking your medicine, you should take the same amount of medicine again. If vomiting persists, consult your doctor.
Usual dose:
Chemotherapy Induced Nausea and Vomiting
You will receive RIVA-ONDANSETRON prior to chemotherapy. Based on how likely you are to experience nausea and/or vomiting, caused by your cancer treatment, your doctor will tell you the amount you need to take and how frequently.
Adult: The dose of Riva-Ondansetron will be between 8 and 32mg a day depending on the potential of your chemotherapy treatment to cause you to vomit and/or have nausea.
Children (4 to 12 years): After chemotherapy, take 4 mg orally every 8 hours for up to 5 days.
Radiotherapy Induced Nausea and Vomiting Adult: Take 8 mg orally 1 to 2 hours before radiotherapy. After therapy, take 8 mg orally every 8 hours for up to 5 days after a course of treatment.
Prevention of Post-Operative Nausea and Vomiting Adult: Take 16 mg orally one hour before anaesthesia.
If you have a liver problem, your dose may be altered. Please follow the instructions of your doctor.
Overdose:
In the event you accidentally take more doses than prescribed, immediately contact your doctor or hospital emergency department or nearest poison control centre.
Missed Dose:
If you miss a dose and do not feel sick, take the next dose when it is due.
If you forget to take your medicine and feel sick or vomit, take a dose as soon as possible.
If your doctor decides to stop the treatment, do Not keep any leftover medicine unless your doctor tells you to.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
You may experience headaches, a feeling of warmness, flushing or constipation, while taking RIVA-ONDANSETRON. There is no need to stop taking your medicine, but you should tell your doctor about these symptoms at your next visit.
If your nausea (feeling of sickness) or vomiting do not improve while taking RIVA-ONDANSETRON, consult your doctor for further advice.
If you feel unwell or have any symptoms that you do not understand, you should contact your doctor immediately.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
| Frequency | Side Effect/Symptom | Talk with your Doctor or Pharmacist | Stop taking drug and call your doctor or pharmacist immediately |
| Uncommon | Heart problems such as fast /slow heart beat, chest pain Seizures Upward rolling of the eyes, abnormal muscular stiffness/body movements/shaki ng. | X | X X |
| Rare | Eye problems such as blurred vision Immediate allergic reaction and symptoms such as swelling of the mouth, throat, difficulty in breathing, rash, hives, increased heart rate | X | X |
| Very Rare | Eye problems such as temporary blindness | X |
This is not a complete list of side effects. For any unexpected effects while taking RIVA-ONDANSETRON, contact your doctor or pharmacist.
HOW TO STORE IT
Keep your medicine in a safe place where children cannot reach it. Your medicine may harm them.
Your RIVA-ONDANSETRON Tablets should be kept at room temperature (15-30⁰C) in a dry place.
Reporting Suspected Side Effects
To monitor drug safety, Health Canada through the Canada Vigilance Program collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada Vigilance:
By toll-free telephone: 866-234-2345
Toll-free fax: 866-678-6789
On-line: www.healthcanada.gc.ca/medeffect By email: CanadaVigilance@hc-sc.gc.ca
By regular mail:
Canada Vigilance National Office
Marketed Health Products Safety and Effectiveness Information Division
Marketed Health products Directorate
Health Products and Food Branch
Health Canada
Tunney’s Pasture, AL 0701 C
Ottawa ON K1A 0K9
NOTE: Before contacting Canada Vigilance, you Should contact your physician or pharmacist.
MORE INFORMATION
Remember: This medicine is for you. Only a doctor can prescribe it for you. Never give it to someone else. It may harm them even if their symptoms are the same as yours.
This leaflet does not contain the complete information about your medicine. If any questions remain unanswered or you are not sure about something, you should ask your doctor or pharmacist.
You may want to read this leaflet again. Please Do not Throw It Away until you have finished your medicine.
This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor,
LaboratoireRiva Inc.,
660 Boul.Industriel, Blainville, Québec
J7C 3V4
Telephone: 450-434-7482
Fax: 450-434-2500
Last Revised: July 2011
J:\Documentation Affaires Réglementaires\Docum\DINSubmission\RIVA\Riva-Ondansetron\ANDS\Riva-Ondansetron PM
2011-06-20.doc, 2011/06/20