MEDICATION GUIDE

PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution

(pol˝ ee eth´ i leen glye´ kol, soeˊ dee um sul' fate, soeˊ dee um klor´ ide, poe tasˊee um klor´ ide,    soeˊ dee um a skor´ bate, as koreˊ bik as´ id for oral solution)

Read this Medication Guide and Instructions for Use before your colonoscopy and again before you start taking PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution.

What is the most important information I should know about PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution? PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution 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:
• abnormal heartbeats that can cause death.
• seizures. This can happen even if you have never had a seizure.
• kidney problems.

Your chance of having fluid loss and changes in body salts with PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution 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 PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution:

• vomiting
• dizziness
• urinating less often than normal
• headache

See "What are the possible side effects of PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution?" for more information about side effects.

What is PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution?

PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution is a prescription medicine used by adults to clean the colon before a colonoscopy. PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution 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 PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution is safe and effective in children.

Who should not take PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution?

Do not take PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution 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 PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution. See the end of this Medication Guide for a complete list of ingredients in PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution.

What should I tell my healthcare provider before taking PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution?

Before taking PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution, 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 alcohol or benzodiazepines.
• are allergic to any of the ingredients in PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution.
• are pregnant or plan to become pregnant. It is not known if PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution 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 PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution passes into your breast milk. You and your healthcare provider should decide if you will take PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution while breastfeeding.

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

PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution may affect how other medicines work. Do not take medicines by mouth 1 hour before or after starting each dose of PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution.

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 (NSAID).
• laxatives. Do not take other laxatives while taking PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution.
• medicines for depression or other mental health problems.
• starch-based thickeners. For patients who have trouble swallowing, do not mix PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution 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 PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution?

See the Instructions for Use for dosing instructions. You must read, understand, and follow these instructions to take PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution the right way. 

• Take PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you to take the Two-Day Split-Dosing regimen option or the One-Day Evening Only Dosing regimen option.
• On the day before the procedure, you can have breakfast, followed by a light lunch (no solid foods), and dinner of clear soup with or without plain yogurt, or plain yogurt only. You must finish dinner at least 1 hour before the start of the first PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution dose.
• Drink only clear liquids before, during, and after you take PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution, until 2 hours before your colonoscopy to help prevent fluid loss (dehydration). 
• Do not eat solid food while taking PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution until after your colonoscopy.
• Do not eat or drink alcohol, milk, anything colored red or purple or any other foods with pulp.
• 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 PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution.
• If you have severe stomach-area (abdomen) discomfort or bloating, stop drinking PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution for a short time or wait a longer time between each dose of PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution until your stomach-area symptoms improve. If your stomach-area discomfort or bloating continues, tell your healthcare provider.
• If you take too much PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution, call your healthcare provider

What are the possible side effects of PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution? PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution can cause serious side effects, including:

• Changes in certain blood tests . Your healthcare provider may do blood tests after you take PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution to check your blood for changes. Tell your healthcare provider if you have any symptoms of too much fluid loss, including:
  • vomiting
  • dizziness
  • feel faint, weak or lightheaded especially when you stand up (orthostatic hypotension)
  • heart problems
  • kidney problems
  • seizures
  • dry mouth
• 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:
  • skin rash
  • swelling of the face, lips, tongue and throat
  • raised red patches on your skin (hives)
  • itching
  • kidney problems

The most common side effects of PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution include:

• anal discomfort
• thirst
• nausea
• stomach area (abdomen pain or bloating)
• sleep problems
• chills
• hunger
• discomfort
• vomiting
• indigestion
• dizziness

These are not all the possible side effects of PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution.

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 PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution?

• Store PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution that has not been mixed with water at room temperature, between 68° to 77°F (20° to 25°C).
• Store PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution that has been mixed with water in an upright position in the refrigerator.
• PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution should be taken within 24 hours after it has been mixed with water.

Keep PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution and all medicines out of the reach of children.

General information about the safe and effective use of PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution for a condition for which it was not prescribed. Do not give PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution to other people, even if they are going to have the same procedure you are. It may harm them.

This Medication Guide summarizes the most important information about PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider

for information that is written for healthcare professionals.

For more information, call 1-866-403-7592

What are the ingredients in PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution?

Active ingredients:

Pouch A: polyethylene glycol (PEG) 3350, sodium sulfate, sodium chloride, potassium chloride.

Pouch B: ascorbic acid and sodium ascorbate.

Inactive ingredients:

Lemon Flavor Pack: Natural lemon flavor, maltodextrin and Saccharin Sodium.

Distributed By:

Teva Pharmaceuticals USA, Inc

North Wales, PA 19454

 

SAP Code: 270438

Rev. 04/2022

This Medication Guide has been approved by the U.S. Food and Drug Administration

Revised: April 2022.