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

SUFLAVE 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.

• have heart problems.
• have kidney problems.
• take water pills (diuretics), high blood pressure medication, 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 SUFLAVE:

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

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

What is SUFLAVE?

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

Do not take SUFLAVE 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).
• an allergy to any ingredient in SUFLAVE. See the end of this Medication Guide for a complete list of the ingredients in SUFLAVE.

Before taking SUFLAVE, 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 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 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 SUFLAVE 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 SUFLAVE passes into your breast milk. You and your healthcare provider should decide if you will take SUFLAVE while breastfeeding.

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

SUFLAVE 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 SUFLAVE.

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 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 SUFLAVE.
• starch-based thickeners. For patients who have trouble swallowing, do notmix SUFLAVE with starch-based thickeners.

The following medicines should be taken at least 2 hours before starting each dose of SUFLAVE and not less than 6 hours after taking each dose of SUFLAVE:
• 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 SUFLAVE?

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

• Take SUFLAVE exactly as your healthcare provider tells you to take it.
• Two doses of SUFLAVE are required for a complete colonoscopy preparation. One dose of SUFLAVE is equal to one bottle plus one flavor enhancing packet.
• It is important for you to drink the additional prescribed amount of water listed in the Instructions for Use to prevent fluid loss (dehydration).
• SUFLAVE is taken using the Split-Dosemethod. See the Instructions for Use for more information.
• All people taking SUFLAVE should follow these general instructions starting 1 day before your colonoscopy:
  o you can eat a low-residue breakfast. Low-residue foods include white bread, biscuits, muffins (no wheat), cornflakes, eggs, cream of wheat, grits, yogurt, cottage cheese, coffee, tea, juice without pulp, and fruit (no skin or seeds).
  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. Examples of clear liquids include water, fruit juices (without pulp), lemonade, coffee, tea (no cream or non-dairy creamer), chicken broth, and gelatin desserts (no fruit or topping).
  o after taking the first dose of SUFLAVE if you have any nausea, bloating or feeling like your stomach is upset, wait to take your second dose of SUFLAVE until your stomach feels better. Start taking your second dose 5 to 8 hours before the colonoscopy, but no sooner than 4 hours from taking your first dose.
• While taking SUFLAVE, do not:
  o take any other laxatives
  o take oral medicines within 1 hour of starting each dose of SUFLAVE
  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 SUFLAVE?

SUFLAVE can cause serious side effects, including:

• See "What is the most important information I should know about SUFLAVE?"
• Changes in certain blood tests.Your healthcare provider may do blood tests after you take SUFLAVE 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. SUFLAVE 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 SUFLAVE including:
  o difficulty breathing                                                   o itching
  o swelling of the face, lips, taongue and throat           o raised red patches on your skin (hives)
  o skin rash

The most common side effects of SUFLAVE include:
• nausea                                                                       • stomach (abdominal) pain
• stomach bloating (abdominal distention)                 • headache

• vomiting

These are not all the possible side effects of SUFLAVE.

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 SUFLAVE?

• Store SUFLAVE at room temperature between 68°F to 77°F (20°C to 25°C).
• Store mixed (reconstituted) SUFLAVE solution in the refrigerator at 36°F to 46°F (2°C to 8°C). Do not freeze.
• Used mixed (reconstituted) SUFLAVE solution within 24 hours.
• After 24 hours, throw away (discard) any mixed (reconstituted) SUFLAVE solution that is not used.

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

General information about the safe and effective use of SUFLAVE.

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