Patient Medication Information: uses, side effects, how to take - Van-Ondansetron

ABOUT THIS MEDICATION

What the medication is used for:

The name of your medicine is VAN-Ondansetron tablets (ondansetron hydrochloride dihydrate). This medicine is one of a group called antiemetics.

VAN-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 radio therapy are thought to cause the release of a natural substance (serotonin), which can cause you to feel sick and to vomit. VAN-Ondansetron helps to stop this from happening, thus preventing you from vomiting or feeling sick.

When it should not be used:

Do not take VAN-Ondansetron if:

you have a history of hypersensitivity (an allergic
reaction) to any ingredient (see What the nonmedicinal ingredients are) in VAN-Ondansetron.
if you are taking apomorphine (used to treat Parkinson’s
disease).

What the medicinal ingredient is:

ondansetron hydrochloride dihydrate.

What the nonmedicinal ingredients are:

VAN-Ondansetron tablets contain the following nonmedicinal ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, pregelatinized starch, magnesium stearate, triacetin, hypromellose (E5), titanium dioxide, ferric oxide yellow

What dosage form it comes in:

VAN-Ondansetron tablets are supplied in two strengths, one contains 4 mg of ondansetron (as ondansetron hydrochloride

dihydrate) and the other contains 8 mg of ondansetron (as ondansetron hydrochloride dihydrate). Your doctor will decide which strength you need.

WARNINGS AND PRECAUTIONS

Before you use VAN-Ondansetron talk to your doctor or pharmacist if:

you have a history of hypersensitivity (an allergic reaction) to any ingredient in VAN-Ondansetron.
If you have had an allergic reaction to medicines similar to
VAN-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 anymore 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 VAN-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 MEDICATIONS

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 knows about all your medications 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 VAN-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 contains 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.

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 VAN-Ondansetron before and/or after chemotherapy. The dose of VAN-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 VAN-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 VAN-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 heartbeat, 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 (dizziness, palpitations, fainting)	X	X X

Serotonin Syndrome: Symptoms of

Serotonin Syndrome have been observed while taking

ondansetron with certain other

medications.

Symptoms include:

Agitation,
confusion,
restlessness,
hallucination, mood changes, unconsciousness, coma.
Fast heartbeat, changes in blood pressure
Muscle shakes, jerks, twitches or stiffness,
overactive reflexes, loss of
coordination
Nausea, vomiting, diarrhea, fever, sweating,
shivering.
X

Very rare

Eye problems such as temporary blindness

Signs of serious skin reactions (skin rash, redness of the skin, blistering of the lips, eyes or mouth, and skin peeling.)

This is not a complete list of side effects. For any unexpected effects while taking VAN-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.

VAN-Ondansetron tablets should be stored between 15°C - 30°C in a dry place.

Reporting Side Effects

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report:

Online at MedEffect;
By calling 1-866-234-2345 (toll-free);
By completing a Consumer Side Effect Reporting
Form and sending it by:
Fax to 1-866-678-6789 (toll-free), or Mail to: Canada Vigilance Program Health Canada, Postal Locator 0701E Ottawa, ON
K1A 0K9

Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.

NOTE: Contact your health professional if you need information about how to manage your side effects. 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 leaflet plus the full product monograph, prepared for health professionals can be obtained by contacting Vanc Pharmaceuticals Inc.

Vanc Pharmaceuticals Inc. Unit-210, 2639 Viking Way

Richmond, BC V6V 3B7

Safety@vancpharm.com

www.vancpharm.com

Help line: +1-877-929-0699

Date of Preparation: 9 november, 2015

Van-Ondansetron: Uses, Side Effects and Dosage