Taking PLENVU

^‡The “One-Day Morning Dosing Regimen” (as it is labeled in the Prescribing Information) is referred to as “Same-Day Morning-of-Colonoscopy Dosing”

INDICATION

PLENVU^® (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride, and potassium chloride
for oral solution) is a prescription medication used by adults to clean the colon before a colonoscopy.

IMPORTANT SAFETY INFORMATION

• Do not take PLENVU® if you have a blockage in your intestine (bowel obstruction), an opening in the wall of your stomach or intestine (bowel perforation), problems with food or fluid emptying from your stomach (gastric retention), a problem with food moving too slowly through your intestines (ileus), a very dilated large intestine, or an allergy to any of the ingredients in PLENVU®.
• It is important to drink sufficient clear liquids before, during, and after the use of PLENVU®. Be sure to consume additional clear liquids after the first dose and second dose of PLENVU®. Stop drinking liquids 2 hours prior to colonoscopy.
• Before you take PLENVU®, talk to your doctor if you:
  • Have problems with serious loss of body fluid (dehydration) and changes in blood salts (electrolytes).
  • Have heart problems or take medication that affects your heart. Your doctor may consider obtaining an electrocardiogram (ECG) test if you are at an increased risk for heart rhythm abnormalities.
  • Have a history of seizures or take antiseizure medication.
  • Have kidney problems or take medication that affects kidney function. Your doctor may want to perform blood testing before and after your colonoscopy.
  • Have a history of stomach or bowel problems, such as ulcerative colitis, a bowel blockage, or a suspected opening in the wall of your stomach or intestine.
  • Have problems swallowing, heartburn (gastric reflux), or if you inhale food or fluid into your lungs when eating or drinking (aspirate).
  • Have a condition that destroys red blood cells, called glucose-6-phosphate dehydrogenase (G6PD) deficiency.
  • Are withdrawing from drinking alcohol.
  • Have phenylketonuria (PKU). PLENVU® contains aspartame equivalent to 491 mg of phenylalanine per treatment.
  • Are pregnant or plan to become pregnant.
  • Are breastfeeding or plan to breastfeed.
• PLENVU® may affect how other medications work. Tell your doctor about all other medications (including prescription and nonprescription medicines, vitamins, and herbal supplements) you take before you take PLENVU®.
• Do not take oral medications within 1 hour before or after starting each dose of PLENVU®. Do not take other laxatives while taking PLENVU® and do not take PLENVU® with starch based thickeners.
• Symptoms of serious allergic reactions may include skin rash, itching, raised red patches on your skin (hives), swelling of the face, lips, tongue, and throat, and kidney problems.
• In clinical studies with PLENVU®, the most common side effects in patients taking PLENVU® were nausea, vomiting, dehydration, and abdominal pain/
  discomfort.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch
or call
1-800-FDA-10881-800-FDA-1088.

For product information, adverse event reports, and product complaint reports, please contact:

Salix Product Information Call Center
Phone: 1-800-321-4576
Fax: 1-510-595-8183
Email: salixmc@dlss.com

Please click here for full Prescribing Information, including Medication Guide and Instructions for Use.