Zuplenz

This medication is used alone or with other medications to prevent nausea and vomiting caused by cancer drug treatment (chemotherapy), radiation treatment, or drugs used to put you to sleep before surgery. Ondansetron works by blocking one of the body's natural substances (serotonin) that causes vomiting.

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using ondansetron oral soluble film and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is made to be dissolved on top of your tongue. Do not chew or swallow the film whole. If giving this medicine to a young child, help them use it properly.

With dry hands, open the protective foil pouch just before using. Remove one film and place on top of your tongue. Allow it to dissolve completely (usually in 4 to 20 seconds), then swallow it with saliva or with liquid. You do not need to take this product with liquid. If your dose is for more than one film, allow each film to dissolve completely before taking the next film. Wash your hands after taking this medication.

To prevent nausea from chemotherapy, take this medication as directed by your doctor, usually 30 minutes before treatment begins. To prevent nausea from radiation treatment, take this medication 1 to 2 hours before the start of your treatment. To prevent nausea after surgery, take ondansetron 1 hour before the start of surgery.

Carefully follow your doctor's directions for taking this medication. Ondansetron may be taken up to 3 times a day for 1 to 2 days after each chemotherapy or radiation treatment. If you are taking this medication on a prescribed schedule, take it regularly in order to get the most benefit from it. To help you remember, take it at the same times each day.

The dosage is based on your medical condition and response to treatment. The dosage for children may also be based on age and weight. Take this medication exactly as directed. Do not take more medication or take it more often than prescribed.

Tell your doctor if your nausea and vomiting persists or if it worsens.

Headache, lightheadedness, dizziness, drowsiness, tiredness, or constipation may occur. If these effects persist or worsen, tell your doctor promptly.

To minimize dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: abdominal pain, muscle spasm/stiffness.

Get medical help right away if any of these rare but very serious side effects occur: chest pain, slow/fast/irregular heartbeat, severe dizziness, fainting.

This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking ondansetron, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: irregular heartbeat, liver problems, stomach/intestinal problems (such as recent abdominal surgery, ileus).

Ondansetron may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using ondansetron, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using ondansetron safely.

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications out of reach of children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some products that may interact with this drug include: apomorphine, tramadol.

Many drugs besides ondansetron may affect the heart rhythm (QT prolongation), including dofetilide, pimozide, procainamide, amiodarone, quinidine, sotalol, macrolide antibiotics (such as erythromycin), among others. Therefore, before using ondansetron, report all medications you are currently using to your doctor or pharmacist.

The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Examples include street drugs such as MDMA/"ecstasy," St. John's wort, certain antidepressants (including SSRIs such as fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine), among others. The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs.

This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Try to take each dose at the scheduled time. If you miss a dose, take it as soon as you remember unless it is near the time for the next dose. In that case, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Do not share this product with others.

Laboratory and/or medical tests (such as EKG) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.