PLENVU- polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, ascorbic acid, sodium ascorbate 
Salix Pharmaceuticals, Inc

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Medication Guide

MEDICATION GUIDE
PLENVU® (plen-vu)
(polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride
and potassium chloride for oral solution)

Read this Medication Guide and Instructions for Use before your colonoscopy and again before you start taking PLENVU.

What is the most important information I should know about PLENVU?

PLENVU and other bowel preparations can cause serious side effects, including:

Serious loss of body fluid (dehydration) and changes in blood salts (electrolytes) in your blood. These changes can cause:
o
abnormal heartbeats that can cause death.
o
seizures. This can happen even if you have never had a seizure.
o
kidney problems.

Your chance of having fluid loss and changes in body salts with PLENVU is higher if you:

 
have heart problems.
have kidney problems.
take water pills (diuretics), high blood pressure medicine or non-steroidal anti-inflammatory drugs (NSAIDs).

Tell your healthcare provider right away if you have any of these symptoms of serious loss of body fluid (dehydration) while taking PLENVU:

vomiting
dizziness
urinating less often than normal
headache

See “What are the possible side effects of PLENVU?” for more information about side effects.

What is PLENVU?
PLENVU is a prescription medicine used by adults to clean the colon before a colonoscopy. PLENVU cleans your colon by causing you to have diarrhea (loose stools). Cleaning your colon helps your healthcare provider see the inside of your colon more clearly during your colonoscopy.
It is not known if PLENVU is safe and effective in children.

Do not take PLENVU if your healthcare provider has told you that you have:

a blockage in your intestine (bowel obstruction).
an opening in the wall of your stomach or intestine (bowel perforation).
problems with food and fluid emptying from your stomach (gastric retention).
a problem with food moving too slowly through your intestines (ileus).
a very dilated intestine (toxic megacolon).
an allergy to any of the ingredients in PLENVU. See the end of this Medication Guide for a complete list of ingredients in PLENVU.

Before taking PLENVU, tell your healthcare provider about all of your medical conditions, including if you:

have problems with serious loss of body fluid (dehydration) and changes in blood salts (electrolytes).
have heart problems.
have seizures or take medicines for seizures.
have kidney problems or take medicines for kidney problems.
have stomach or bowel problems, including ulcerative colitis.
have problems with swallowing, gastric reflux or if you inhale food or fluid into your lungs when eating or drinking (aspirate).
have a condition called glucose-6-phosphate dehydrogenase (G6PD) deficiency that destroys red blood cells.
are withdrawing from drinking alcohol.
have phenylketonuria (PKU). PLENVU contains phenylalanine.
are allergic to any of the ingredients in PLENVU.
are pregnant or plan to become pregnant. It is not known if PLENVU will harm your unborn baby. Talk to your healthcare provider if you are pregnant.
are breastfeeding or plan to breastfeed. It is not known if PLENVU passes into your breast milk. You and your healthcare provider should decide if you will take PLENVU while breastfeeding.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

PLENVU may affect how other medicines work. Do not take medicines by mouth 1 hour before or after starting each dose of PLENVU.

Especially tell your healthcare provider if you take:

medicines to treat a blood salt (electrolyte) imbalance.
medicines for blood pressure or heart problems.
medicines for seizures (antiepileptics).
medicines for kidney problems.
water pills (diuretics).
non-steroidal anti-inflammatory drugs (NSAIDs).
laxatives. Do not take other laxatives while taking PLENVU.
medicines for depression or other mental health problems.
starch based thickeners. For patients who have trouble swallowing, do not mix PLENVU with starch-based thickeners

Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure if you are taking any of the medicines listed above.

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

How should I take PLENVU?

See the Instructions for Use for dosing instructions. You must read, understand, and follow these instructions to take PLENVU the right way.

Take PLENVU exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you to take the Two-Day Split-Dosing option or the One-Day Morning Dosing option.
Drink clear liquids before, during, and after you take PLENVU, up until 2 hours before your colonoscopy, to help prevent fluid loss (dehydration) and changes in blood salt (electrolyte) levels.
Do not eat solid food while taking PLENVU until after your colonoscopy.
It is important for you to drink the additional amount of clear liquids listed in the Instructions for Use.
You may have stomach-area (abdomen) bloating after your first dose of PLENVU.
o
If you have severe stomach-area (abdomen) discomfort or bloating, stop drinking PLENVU for a short time or wait a longer time between each dose of PLENVU until your stomach-area symptoms improve. If your stomach‑area discomfort or bloating continues, tell your healthcare provider.
Your first bowel movement may happen about 1 to 2 hours after you start taking PLENVU.
If you take too much PLENVU, call your healthcare provider.

What are the possible side effects of PLENVU?

PLENVU can cause serious side effects including:

Changes in certain blood tests. Your healthcare provider may do blood tests after you take PLENVU to check your blood for changes. Tell your healthcare provider if you have any symptoms of too much fluid loss, including:
o
vomiting
o
dizziness
o
heart problems
o
kidney problems
o
seizures
o
dry mouth
o
feel faint, weak or lightheaded especially when you stand up (orthostatic hypotension)
Ulcers of the bowel or bowel problems (ischemic colitis): Tell your healthcare provider right away if you have severe stomach-area (abdomen) pain or rectal bleeding.
Serious allergic reactions. Symptoms of a serious allergic reaction may include:
o
skin rash
o
itching
o
raised red patches on your skin (hives)
o
swelling of the face, lips, tongue and throat
o
kidney problems

The most common side effects of PLENVU include:

nausea
vomiting
dehydration
stomach pain or discomfort

These are not all the possible side effects of PLENVU.

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 PLENVU?

Store PLENVU (before opening and after mixed) at room temperature, between 68°F to 77°F
(20°C to 25°C). PLENVU (before opening and after mixed) may also be stored in a refrigerator.
Use PLENVU within 24 hours after mixing with water.

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

General information about the safe and effective use of PLENVU.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use PLENVU for a condition for which it was not prescribed. Do not give PLENVU to other people, even if they are going to have the same procedure you are. It may harm them.

You can ask your pharmacist or healthcare provider for information that is written for health professionals.

What are the ingredients in PLENVU?

Active ingredient:

Dose 1: PEG 3350, sodium sulfate, sodium chloride, potassium chloride

Dose 2 Pouch A: PEG 3350, sodium chloride, potassium chloride

Dose 2 Pouch B: sodium ascorbate, ascorbic acid

Inactive ingredients:

Dose 1: sucralose, encapsulated citric acid, mango flavoring

Dose 2 Pouch A: aspartame, fruit punch flavoring

Distributed by:

Salix Pharmaceuticals, a division of

Bausch Health US, LLC

Bridgewater, NJ 08807 USA

Manufactured by:

Norgine Limited

7 Tir-y-berth Industrial Estate

New Road, Tir-y-berth

Hengoed, CF82 8SJ

United Kingdom (GBR)

U.S. Patent Numbers: 8,999,313; 9,326,969; 9,592,252; 9,707,297; 10,016,504; 10,646,512; 10,780,112 and 10,792,306

PLENVU is a registered trademark of the Norgine group of companies used under license.

© 2021 Salix Pharmaceuticals, Inc. or its affiliates

For more information, go to www.PLENVU.com or call 1-800-321-4576.

This Medication Guide has been approved by the U.S. Food and Drug Administration.                          Issued: 05/2021
                                                                                                                                                                           9643002 70015340

Revised: 5/2021
Salix Pharmaceuticals, Inc