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

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

Serious loss of body fluid (dehydration) and changes in body 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 SUTAB is higher if you:

• have heart problems.
• have kidney problems.
• take water pills (diuretics) 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 SUTAB:

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

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

What is SUTAB?

SUTAB is a prescription medicine used by adults to clean the colon before a colonoscopy. SUTAB 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 SUTAB is safe and effective in children.

Do nottake SUTAB if your healthcare provider has told you that you have:

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

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

• have heart problems.
• have stomach or bowel problems including ulcerative colitis.
• have problems with swallowing or gastric reflux.
• have a history of seizures.
• are withdrawing from drinking alcohol or from taking benzodiazepines.
• have a low blood salt (sodium) level.
• have kidney problems.
• are pregnant. It is not known if SUTAB 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 SUTAB passes into your breast milk. You and your healthcare provider should decide if you will take SUTAB while breastfeeding.

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

SUTAB 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 SUTAB.

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 drugs (NSAIDs).
• medicines for depression or other mental health problems.
• laxatives. Do nottake other laxatives while taking SUTAB.

The following medicines should be taken at least 2 hours before starting each dose of SUTAB and not less than 6 hours after taking each dose of SUTAB:
• tetracycline                                     • iron                           • chlorpromazine
• fluoroquinolone antibiotics            • digoxin                     • penicillamine

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 SUTAB?

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

• Take SUTAB exactly as your healthcare provider tells you to take it.
• Each bottle contains 12 tablets and a drying agent (desiccant) canister to keep the tablets dry. Remove and throw away (discard) the drying agent (desiccant) canister from both bottles. Use the second bottle for the second dose on the morning of the colonoscopy.
• Each dose of SUTAB is 12 tablets that must be taken while drinking 16 ounces of water. Two doses of SUTAB (24 tablets) are required for a complete colonoscopy preparation.
• It is important for you to drink the additional 32 ounces of water after each dose to prevent fluid loss (dehydration).
• SUTAB is taken using the Split-Dosemethod. See the Instructions for Use for more information.
• All people taking SUTAB should follow these general instructions starting 1 day before your colonoscopy:
  o you can eat a low-residue breakfast. Low-residue foods include eggs, white bread, cottage cheese, yogurt, grits, coffee and tea.
  o after breakfast only drink clear liquids all day and the next day until 2 hours before your colonoscopy. Stop drinking all fluids at least 2 hours before the colonoscopy.
  o after taking the first dose of SUTAB (12 tablets) if you have any bloating or feeling like your stomach is upset, wait to take your second dose of 12 tablets until your stomach feels better.
• While taking SUTAB, do not:
  o take any other laxatives.
  o take any medicines by mouth (oral) within 1 hour of starting SUTAB.
  o eat solid foods, dairy such as milk, or drink alcohol.
  o eat or drink anything colored red or purple.

What are the possible side effects of SUTAB?

SUTAB can cause serious side effects, including:

• See What is the most important information I should know about SUTAB?
• Changes in certain blood tests.Your healthcare provider may do blood tests after you take SUTAB 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 (abdominal)                                 o headache
  o urinate less than usual                       cramping
  o trouble drinking clear liquid
• Heart problems. SUTAB may cause abnormal heartbeats.
• Seizures.
• Ulcers of the bowel or bowel problems (ischemic colitis).Tell your healthcare provider right away if you have severe stomach-area (abdominal) pain or rectal bleeding.
• Serious allergic reactions.Get medical help right away if you have any signs and symptoms of a serious allergic reaction while taking SUTAB, including:
  o Swelling of your hands, face                         o rash
  lips, mouth or tongue                                       o severe itching
  o breathing problems                                       o raised red patches on your skin

The most common side effects of SUTAB include:
• nausea                                                                       • vomiting
• stomach-area swelling (abdominal distention)         • upper stomach (abdominal) pain

These are not all the possible side effects of SUTAB.

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 SUTAB?

Each SUTAB bottle contains a drying agent (desiccant) canister to help keep the tablets dry (protect from moisture).

Store SUTAB at room temperature between 68°F to 77°F (20°C to 25°C).

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

General information about the safe and effective use of SUTAB.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SUTAB for a condition for which it was not prescribed. Do not give SUTAB 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.