Patient Medication Information: uses, side effects, how to take - Nu-Ondansetron (Nu-Pharm, 4 mg, 8 mg)
ABOUT THIS MEDICATION
What the medication is used for:
The name of your medicine is NU-ONDANSETRON Tablets (ondansetron hydrochloride dihydrate). This medicine is one of a group called antiemetics.
NU- 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. NU- ONDANSETRON helps to stop this from happening, thus preventing you from vomiting or feeling sick.
When it should not be used:
Do not take NU- ONDANSETRON if:
you have a history of hypersensitivity (an
allergic reaction) to any ingredient (see What the important nonmedicinal ingredients are).
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 ingredient is:
Ondansetron hydrochloride dihydrate.
What the important nonmedicinal ingredients are:
NU- ONDANSETRON tablets contain the following non-medicinal ingredients: croscarmellose sodium, hydroxypropylcellulose, hydroxypropyl
methylcellulose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, titanium dioxide and for the 8mg tablets, a yellow colouring agent containing yellow iron oxide.
What dosage forms it comes in:
NU-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 NU- ONDANSETRON talk to your doctor or pharmacist if:
you have a history of hypersensitivity (an allergic reaction) to any ingredient in NU-
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
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), NU- 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 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 NU- ONDANSETRON will be between 8 and 32 mg 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 left over 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 NU- 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 does not improve while taking NU- 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 AND WHAT TO DO ABOUT THEM
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking the drug and call your doctor or pharmacist immediately | |
| Uncommon | Heart problems such as fast/ slow heart beat, chest pain | 9 | |
| Seizures | 9 | ||
| Upward rolling of the eyes, abnormal muscular stiffness/ body movements/ shaking | 9 | ||
| Rare | Eye problems such as blurred vision | 9 | |
Immediate allergic reaction and symptoms such as swelling of the mouth, throat, difficulty in breathing, rash, hives, increased heart rate | 9 | ||
| Very Rare | Eye problems such as temporary blindness | 9 | |
This is not a complete list of side effects. For any unexpected effects while taking NU-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.
NU-ONDANSETRON tablets should be kept at room temperature (15°C-30°C) in a well closed container and protected from light.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health product to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free to 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 0701C Ottawa, ON K1A 0K9 Postage paid labels, Canada Vigilance Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you should require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
For more information, please contact your doctor, pharmacist or other healthcare professional.
This leaflet plus the full product monograph, prepared for health professionals, can be obtained by contacting the sponsor, Nu-Pharm Inc. at:
1-800-267-1438