Patient Medication Information: uses, side effects, how to take - Ava-Ondansetron
ABOUT THIS MEDICATION
What the medication is used for:
The name of your medicine is Ava-Ondansetron tablets (ondansetron hydrochloride dihydrate). This medicine is one of a group called antiemetics.
Ava-Ondansetron is intended to prevent the nausea (feeling of sickness) and vomiting, which can occur while undergoing cancer chemotherapy and radiotherapy, or after receiving general anaesthesia during an operation.
What it does:
These treatments are thought to cause the release of natural substance (serotonin), which can cause you to feel sick and to vomit. Ondansetron stops this from happening and helps prevent you from vomiting or feeling sick.
When it should not be used:
Do not take Ava-Ondansetron tablets:
If you have a history of hypersensitivity (an allergic
reaction) to any ingredient in Ava-Ondansetron (see What the important nonmedicinal ingredients are).
What the medicinal ingredient is:
The medicinal ingredient is ondansetron (as hydrochloride dihydrate).
What the important nonmedicinal ingredients are:
Ava-Ondansetron tablets also contain : cellulose microcrystalline, lactose monohydrate, maize starch (pregelatinised), magnesium stearate, hypromellose, titanium dioxide, ferric oxide yellow.
What dosage forms it comes in:
Ava-Ondansetron tablets is supplied as 8 milligrams of ondansetron. Your doctor will decide which strength you need.
WARNINGS AND PRECAUTIONS
BEFORE you use Ava-Ondansetron talk to your doctor or pharmacist if:
- you have a history of hypersensitivity (an allergic reaction) to the drug or any components of its composition.
you are pregnant or likely to become pregnant.
- you are breast feeding.
- you have liver problems.
- you have signs of intestinal obstruction.
- you have 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.
INTERACTIONS WITH THIS MEDICATION
Tell your doctor about all medicines you are taking including those you have bought yourself. If you are taking any medicines containing tramadol, (such as TRAMACET) Ava-Ondansetron tablets may reduce 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 Ava-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.
Adults: The dose of Ava-Ondansetron will depend on the potential of your chemotherapy treatment to cause you to vomit and /or have nausea.
Children (4 to 12 years old): 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 Postoperative Nausea and Vomiting Adults: 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 Ava-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 ondansetron, consult your doctor for further advice.
If you feel unwell or have 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 the drug and call your doctor or pharmacist |
| Uncommon | Heart problems such as fast/slow heart beat, chest pain Seizures | 9 9 | |
| 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 | 9 | 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 Ava-Ondansetron tablets, 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.
Ava-Ondansetron tablets should be kept at room temperature in a well closed container and protected from light. Do not refrigerate or freeze.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada 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 by:
Toll-free telephone: 1-866-234-2345
Toll-free fax: 1-866-678-6789
By email: cadrmp@hc-sc.gc.ca
By regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness Information Division
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Before contacting Health Canada, 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, Avanstra Inc., at: 1-855-708-3678
or
by written request at:
10761-25th NE, Suite 110, Building B,
Calgary, Alberta, Canada
T2C 3C2
or by e-mail at :
medinfo@avanstra.com
February 11, 2011