What is the most important information I should know about SUPREP Bowel Prep Kit?

SUPREP Bowel Prep Kit 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 SUPREP Bowel Prep Kit is higher if you:

   • have kidney problems

   • take water pills or non-steroidal anti-inflammatory drugs (NSAIDS)

Tell your healthcare provider right away if you have any of these symptoms of a loss of too much body fluid (dehydration) while taking SUPREP Bowel Prep Kit:

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

See What are the possible side effects of SUPREP Bowel Prep Kit? for more information about side effects.

What is SUPREP Bowel Prep Kit?

SUPREP Bowel Prep Kit is a prescription medicine used by adults and children 12 years of age and older to clean the colon before a colonoscopy. SUPREP Bowel Prep Kit cleans your colon by causing you to have diarrhea. Cleaning your colon helps your healthcare provider see the inside of your colon more clearly during your colonoscopy.

It is not known if SUPREP Bowel Prep Kit is safe and effective in children under 12 years of age.

Do not take SUPREP Bowel Prep Kit 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)
   • a very dilated intestine (toxic megacolon)
   • problems with the emptying of food and fluid from your stomach (gastric retention)
   • an allergy to any of the ingredients in SUPREP Bowel Prep Kit. See the end of this Medication Guide for a complete list of ingredients in
      SUPREP Bowel Prep Kit.

Before taking SUPREP Bowel Prep Kit, 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 gout
   • have heart problems including an irregular heartbeat, especially a condition called "QT prolongation".
   • have a history of seizures or take medicines for seizures.
   • are withdrawing from drinking alcohol or from taking benzodiazepines.
   • have a low blood salt (sodium) level.
   • have kidney problems or take medicines for kidney problems.
   • have stomach or bowel problems including ulcerative colitis.
   • have problems with swallowing or gastric reflux.
   • are pregnant or plan to become pregnant. It is not known if SUPREP Bowel Prep Kit 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 SUPREP Bowel Prep Kit passes into your breast milk. You and your healthcare
      provider should decide if you will take SUPREP Bowel Prep Kit while breastfeeding.

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

SUPREP Bowel Prep Kit may affect how other medicines work. Medicines taken by mouth may not be absorbed properly when taken within 1 hour before the start of each dose of SUPREP Bowel Prep Kit.

Especially tell your healthcare provider if you take:
   • medicines for blood pressure or heart problems.
   • medicines for kidney problems.
   • medicines for seizures.
   • water pills (diuretics).
   • non-steroidal anti-inflammatory medicines (pain medicines).
   • medicines for depression or mental health problems.
   • laxatives. Do not take other laxatives while taking SUPREP Bowel Prep Kit.

The following medicines should be taken at least 2 hours before starting SUPREP Bowel Prep Kit and not less than 6 hours after taking SUPREP Bowel Prep Kit:
   • tetracycline
   • fluoroquinolone antibiotics
   • iron
   • digoxin (Lanoxin)
   • chloropromazine
   • penicillamine (Cuprimine. Depen)

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 SUPREP Bowel Prep Kit?

See the Instructions for Use in the Patient Instructions for Use Booklet for dosing instructions. You must read, understand, and follow these instructions to take SUPREP Bowel Prep Kit the right way.

   • Take SUPREP Bowel Prep Kit exactly as your healthcare provider tells you to take it.
   • Each bottle of SUPREP Bowel Prep Kit must be mixed with water (diluted) before drinking.
   • It is important for you to drink the additional prescribed amount of water listed in the Instructions for Use to prevent fluid loss
      (dehydration).
   • One bottle of SUPREP Bowel Prep Kit is equal to one dose.
   • Two doses of SUPREP Bowel Prep Kit are required for complete colonoscopy preparation.
   • All people taking SUPREP Bowel Prep Kit should follow these general instructions starting 1 day before your colonoscopy:
         • eat only a light breakfast or clear liquids (for example: water, strained fruit juice without pulp, lemonade, plain coffee or tea, chicken
            broth, gelatin dessert without fruit) on the day before your procedure.
         • only drink clear liquids the rest of the day and the next day until 2 hours before your colonoscopy. Stop drinking all fluids at least 2
            hours before your colonoscopy.
         • after taking SUPREP Bowel Prep Kit if you have any bloating or feeling like your stomach is upset, wait to take your second dose until
            your stomach feels better.

• While taking SUPREP Bowel Prep Kit, do not:

         • take any other laxatives.
         • take any medicines by mouth (oral) within 1 hour of starting SUPREP Bowel Prep Kit.
         • eat solid foods, drink dairy (such as milk), or drink alcohol while taking SUPREP Bowel Prep Kit and until after your colonoscopy
         • eat or drink anything colored red or purple.
Contact your healthcare provider right away if after taking SUPREP Bowel Prep Kit you have severe vomiting, signs of dehydration, changes in consciousness such as feeling confused, delirious or fainting (loss of consciousness) or seizures after taking SUPREP Bowel Prep Kit.

What are the possible side effects of SUPREP Bowel Prep Kit?

SUPREP Bowel Prep Kit can cause serious side effects, including:

   • See What is the most important information I should know about SUPREP Bowel Prep Kit?
• Changes in certain blood tests. Your healthcare provider may do blood tests after you take SUPREP Bowel Prep Kit to check your blood
      for changes. Tell your healthcare provider if you have any symptoms of too much fluid loss, including:
  o vomiting                                         o nausea                                                        o bloating
  o dizziness                                         o stomach area (abdomen) cramping           o headache
  o urinate less than usual                    o trouble drinking clear liquid                      o trouble swallowing
  o seizures                                           o heart problems                                          o worsening gout
•  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.

The most common side effects of SUPREP Bowel Prep Kit in adults include:

  o overall discomfort                                                                o stomach bloating
  o stomach pain                                                                        o nausea
  o vomiting

The most common side effects of SUPREP Bowel Prep Kit in children 12 to 16 years of age include:
  o nausea                                                                                 o stomach pain
  o stomach bloating                                                                 o vomiting

These are not all the possible side effects of SUPREP Bowel Prep Kit.

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 SUPREP Bowel Prep Kit?

   • Store SUPREP Bowel Prep Kit at room temperature, between 68°F to 77°F (20°C to 25°C).

Keep SUPREP Bowel Prep Kit and all medicines out of the reach of children.

General information about the safe and effective use of SUPREP Bowel Prep Kit.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SUPREP Bowel Prep Kit for a condition for which it was not prescribed. Do not give SUPREP Bowel Prep Kit 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 about SUPREP Bowel Prep Kit that is written for healthcare professionals.