Patient Medication Information: uses, side effects, how to take - Bio-Ondansetron
ABOUT THIS MEDICATION
What the medication is used for:
The name of your medicine is Bio-ONDANSETRON Tablets (Ondansetron hydrochloride). This medicine is one of a group called antiemetics.
Bio-ONDANSETRON is used for:
- the prevention of nausea (feeling of sickness) and vomiting during treatment for cancer (chemotherapy and radiotherapy).
- the prevention and treatment of nausea and vomiting after surgery.
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. Bio-ONDANSETRON helps to stop this from happening, thus preventing you from vomiting or feeling sick. When it should not be used:
Do not take Bio-ONDANSETRON if:
- you have a history of hypersensitivity (an allergic reaction) to any ingredient (see What the nonmedicinal ingredients are) in Bio-ONDANSETRON
- If you are taking apomorphine (used to treat Parkinson’s disease)
What the medicinal ingredient is:
Bio-ONDANSETRON tablets contain ondansetron hydrochloride dihydrate as the medicinal ingredient. What the nonmedicinal ingredients are:
Bio-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:
Bio-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 Bio-ONDANSETRON talk to your doctor or pharmacist if:
you have a history of hypersensitivity (an allergic reaction) to any ingredient in Bio-ONDANSETRON
- If you have had an allergic reaction to medicines similar to Bio-ONDANSETRON such as medicines containing granisetron or palonosetron.
you are pregnant or likely to become pregnant.
- you are breast feeding
- 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 any more medicine unless your doctor tells you to do so.
Serotonin Syndrome is a rare but potentially life-threatening reaction that may occur if you take ondansetron with certain other medications. It may cause serious changes in how your brain, muscles and digestive system work. Be sure to tell your healthcare professional all the medicines you are taking.
INTERACTIONS WITH THIS MEDICATION
As with most medicines, interactions with other drugs are possible. To avoid potentially life-threatening reactions tell your healthcare professional about ALL the medications you take, including those prescribed by other doctors, vitamins, minerals, natural supplements or alternative medicines. It is important that your doctor know about all your medication so that you get the best possible treatment. Tell your doctor if you are taking carbamazepine, phenytoin or rifampicin. If you are taking any medicines containing tramadol, Bio-ONDANSETRON may decrease its effectiveness.
Also, make sure you tell your doctor or pharmacist if you are taking:
- Drugs used to treat heart rhythm disorders
- Other drugs that may disturb heart rhythm
- Antipsychotics
- Antidepressants
- Antibiotics or antifungals
- Opiod analgesics (painkillers)
- Other drugs to treat nausea and vomiting
- Asthma drugs
- Cancer drugs
- Diuretics
- Other drugs that affect serotonin including SSRI*s, SNRI**s, triptans, MAOIs*** (including the antibiotic linezolid and methylene blue), drugs that contain tryptophan, or St. John’s Wort.
*SSRI (Selective Serotonin-Reuptake Inhibitors) – used to treat depression or anxiety, e.g. escitalopram, citalopram, fluoxetine, paroxetine, sertraline.
**SNRI (Serotonin Noradrenalin Reuptake Inhibitors) – used to treat depression or anxiety, e.g. duloxetine, venlafaxine, desvenlafaxine.
***MAOIs (Monoamine Oxidase Inhibitors) – used to treat depression, Parkinson’s disease, e.g., phenelzine, rasagiline, selegiline.
| IMPORTANT: PLEASE READ |
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. Adult: You may receive Bio-ONDANSETRON before and/or after chemotherapy. The dose of Bio-ONDANSETRON is between 8 and 24 mg 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
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 case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. 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 Bio-ONDANSETRON. Although uncommon, low blood pressure and hiccups have also been reported.
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 Bio-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 seek immediate emergency assistance |
| Uncommon | Heart problems such as fast /slow heart beat, chest pain | X | |
| Seizures | X | ||
| Upward rolling of the eyes, abnormal muscular stiffness/body movements/shaking. | X | ||
| Rare | Eye problems such as blurred vision | X | |
| Immediate allergic reaction and symptoms such as swelling of the mouth, throat, difficulty in breathing, rash, hives, increased heart rate | X | ||
| Disturbance in heart rhythm (dizziness, palpitations, fainting) | X | ||
Serotonin Syndrome: Symptoms of Serotonin Syndrome have been observed while taking Ondansetron with certain other medications. Symptoms include: •agitation, confusion, restlessness, hallucinations, mood changes, unconsciousness, coma. •fast heartbeat, changes in blood pressure
| X | ||
| Very Rare | Eye problems such as temporary blindness. | X | |
| Signs of serious skin reactions (skin rash, redness of the skin, blistering of the lips, eyes or mouth, and skin peeling.) | X | ||
This is not a complete list of side effects. For any unexpected effects while taking Bio-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.
| IMPORTANT: PLEASE READ |
Bio-Ondansetron Page 29 of 29 Your Bio-ONDANSETRON 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 Canada 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, or
- 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 MedEffect™ 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 found by contacting Biomed Pharma
Biomed Pharma
100-5950, Ch. de la Côte de Liesse
Mont-Royal, QC H4T 1E2
Phone# (514) 731-2003; Fax: (514) 731-2004
Date of preparation: September 10, 2015