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Zuplenz

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Zuplenz

PATIENT INFORMATION

ZUPLENZ®
(ZOO-plenz)
(ondansetron) Oral Soluble Film

What is ZUPLENZ®?

ZUPLENZ is a prescription medicine that is used in adults to prevent nausea and vomiting:

In children 4 years of age and older, ZUPLENZ is only used to prevent nausea and vomiting that happens with certain cancer chemotherapy medicines.

It is not known if ZUPLENZ is safe and works in children to prevent nausea and vomiting with radiation therapy, or nausea and vomiting that may happen after surgery in children.

Who should not take ZUPLENZ?

Do not take ZUPLENZ if you:

  • take apomorphine hydrochloride (Apokyn)
  • have had an allergic reaction to ZUPLENZ or are allergic to any of its ingredients. See the end of this leaflet for a complete list of ingredients in ZUPLENZ.

What should I tell my doctor before taking ZUPLENZ?

Before you take ZUPLENZ, tell you doctor if you:

  • have any heart problems, including a condition called “congenital long QT syndrome
  • take a medicine that causes heart problems (QT prolongation)
  • have low blood levels of potassium or magnesium
  • have liver problems
  • have any other medical conditions
  • are pregnant or plan to become pregnant. It is not known if ZUPLENZ will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if ZUPLENZ passes into your breast milk.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines may affect how ZUPLENZ works, and ZUPLENZ may affect how other medicines work. Taking ZUPLENZ with certain other medicines may cause serious side effects. Especially tell your doctor if you take:

  • apomorphine hydrochloride (Apokyn)
  • tramadol hydrochloride (Ultram, Ultram ER, Ryzolt, ConZip, Rybix ODT)
  • any other medicine for nausea and vomiting

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I take ZUPLENZ?

  • Take ZUPLENZ exactly as your doctor tells you to take it.
  • If you take too much ZUPLENZ, call your doctor or go to the nearest hospital emergency room right away.
  • An adult should help a young child use ZUPLENZ.

Read the Instructions for Use at the end of this Patient Information for information about the right way to take ZUPLENZ.

What should I avoid while taking ZUPLENZ?

ZUPLENZ may cause dizziness. Do not drive, operate machinery, or do other dangerous activities until you know how ZUPLENZ affects you.

What are the possible side effects of ZUPLENZ?

ZUPLENZ may cause serious side effects, including:

  • severe allergic reactions. Stop taking ZUPLENZ and get medical help right away if you have any of these signs or symptoms of an allergic reaction to ZUPLENZ:
    • rash
    • hives
    • itching
    • trouble breathing
    • chest tightness or chest pain
    • swelling of your mouth, face, lips, or tongue
  • heart rhythm changes. ZUPLENZ can cause a change in the electrical activity in your heart called QT prolongation, which can cause irregular heartbeats.

The most common side effects of ZUPLENZ include:

  • headache
  • tiredness and body discomfort
  • constipation
  • diarrhea

These are not all the possible side effects of ZUPLENZ. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store ZUPLENZ?

  • Store ZUPLENZ at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep ZUPLENZ in the foil pouch until ready to use. Keep foil pouches in the carton.
  • Use ZUPLENZ right after you take it out of the pouch.

Keep ZUPLENZ and all medicines out of the reach of children.

General information about the safe and effective use of ZUPLENZ

Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use ZUPLENZ for a condition for which it was not prescribed. Do not give ZUPLENZ to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your doctor or pharmacist for information about ZUPLENZ that is written for health professionals.

For more information, go to www.ZUPLENZ.com or call 1 855 636 5710.

What are the ingredients in ZUPLENZ?

Active ingredient: ondansetron

Inactive ingredients: butylated hydroxytoluene, calcium carbonate, colloidal silicon dioxide, erythritol, hypromellose, monoammonium glycyrrhizinate, peppermint flavor, polyethylene oxide, sodium bicarbonate, sucralose, titanium dioxide and xanthan gum.

Instructions for Use

ZUPLENZ®
(ZOO-plenz)
(ondansetron) Oral Soluble Film

Step 1. Keep the ZUPLENZ film in the foil pouch until ready to use. Use ZUPLENZ film right away after you take it out of the pouch.

Step 2. Make sure your hands are dry.

Step 3. Fold the pouch along the dotted line to expose the tear notch. See Figure A.

Figure A

Expose the tear notch - Illustration

Step 4. While still folded, tear the pouch carefully along the edge. See Figure B.

Figure B

Tear the pouch carefully along the edge - Illustration

Step 5. Take the ZUPLENZ film out of the pouch. See Figure C.

Figure C

Take the ZUPLENZ film out - Illustration

Step 6. Put the ZUPLENZ film on top of your tongue. It will dissolve in 4 to 20 seconds. See Figure D

Figure D

Put the ZUPLENZ film on top of your tongue - Illustration

Step 7. Do not chew or swallow the film whole.

Step 8. Swallow after the ZUPLENZ film dissolves. You may swallow the dissolved film with or without liquid.

Step 9. Wash your hands after taking ZUPLENZ.

How should I store ZUPLENZ?

  • Store ZUPLENZ at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep ZUPLENZ in the foil pouch until ready to use. Keep foil pouches in the carton.
  • Use ZUPLENZ right after you take it out of the pouch.

Keep ZUPLENZ and all medicines out of the reach of children.

This “Instructions for Use” has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 10/1/2014
This monograph has been modified to include the generic and brand name in many instances.

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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