Patient Medication Information: uses, side effects, how to take - Ondansetron-Odan
ABOUT THIS MEDICATION
What the medication is used for:
The name of your medicine is ONDANSETRON-ODAN Tablets (Ondansetron hydrochloride). This medicine is one of a group called antiemetics.
ONDANSETRON-ODAN 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 anesthesia, 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. ONDANSETRON-ODAN helps to stop this from happening, thus preventing you from vomiting or feeling sick.
When it should not be used:
Do not take ONDANSETRON-ODAN if:
you have a history of hypersensitivity
(an allergic reaction) to any ingredient (see What the nonmedicinal ingredients are) in ONDANSETRON-ODAN.
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.
If you are taking apomorphine (used to treat
Parkinson’s disease)
What the medicinal ingredient is:
ONDANSETRON tablets contain Ondansetron hydrochloride dihydrate as the medicinal ingredient.
What the important non-medicinal ingredients are:
ONDANSETRON-ODAN tablets contain the following non-medicinal ingredients: Lactose, Microcrystalline Cellulose, Croscarmellose Sodium, Pregelatinized Starch, Magnesium Stearate, Hydroxypropyl Methylcellulose, Triacetin, Iron Oxide Yellow and Titanium Dioxide.
What dosage forms it comes in:
ONDANSETRON-ODAN 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 ONDANSETRON-ODAN, talk to your doctor or pharmacist if:
you have a history of hypersensitivity,
(an allergic reaction) to any ingredient to in ONDANSETRON-ODAN.
- 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
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, ONDANSETRON-ODAN 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
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.
Adults: You may receive ONDANSETRON-ODAN before and/or after chemotherapy. The dose of ONDANSETRON-ODAN will be between 8 and 24mg a day (taken orally) for up to 5 days 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 Adults: 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 Adults: Take 16 mg orally one hour before anesthesia.
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 ONDANSETRON-ODAN. 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 ONDANSETRON-ODAN, 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/shaking | 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 Disturbance in heart rhythm (sometimes causing sudden loss of consciousness) | X | 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 ONDANSETRON-ODAN, 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.
ONDANSETRON-ODAN tablets should be kept at room temperature (15-30°C) in a well closed container and protect from light. Do not refrigerate or freeze.
.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canadian Vigilance Program by one of the following 3 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, 0r
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
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,
Odan Laboratories Ltd.
325 Stillview Avenue, Pointe Claire, Quebec, H9R 2Y6
Telephone: 514-428-1628
Fax: 514-428-9783