Polibar ACB

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Very bad and sometimes deadly allergic reactions have rarely happened. Talk with your doctor.
• This medicine prevents many other drugs from getting into the body. If you take other drugs, check with your doctor or pharmacist to see if you need to take them at some other time than Polibar ACB.
• To prevent hard stools (constipation) or bowel block from this medicine, your doctor may have you use a laxative like milk of magnesia or lactulose after using Polibar ACB. Follow what your doctor has told you. Talk with your doctor.
• Drink lots of noncaffeine liquids after using this medicine unless told to drink less liquid by your doctor.
• If you are 65 or older, use Polibar ACB with care. You could have more side effects.
• Some products are not approved for use in children. Talk with the doctor.
• Some products have sorbitol in them. Very bad health problems like low blood sugar, bleeding, and kidney failure have happened when people who are not able to break down fructose took a product with sorbitol in it. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Use Polibar ACB as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Follow what your doctor has told you to do.
• Shake well before use.
• Most of the time, this medicine is taken by mouth. Take as you have been told by your doctor.
• Some brands of Polibar ACB are to be taken with food. Some brands may be taken with or without food. Ask your pharmacist if you need to take your brand with food.
• Some products may be used as an enema. If you are using this medicine as an enema, it will be given rectally by your doctor.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very hard stools (constipation).
• Very bad belly pain.
• Shortness of breath.
• Very bad dizziness or passing out.
• A heartbeat that does not feel normal.
• Flushing.
• Fast or slow heartbeat.
• Feeling agitated.
• Feeling confused.
• Blue or gray skin color.
• Feeling very tired or weak.
• Pale skin.
• Ringing in ears.
• Sweating a lot.
• Chest pain or pressure.
• Coughing up blood.
• Swelling, warmth, numbness, change of color, or pain in a leg or arm.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.
• Loose stools (diarrhea).
• Stomach cramps.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Most of the time, Polibar ACB (barium suspension) will be given in a hospital or doctor's office. If stored at home, follow how to store as you were told by the doctor.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Polibar® ACB is a barium sulfate for suspension (96% w/w) for rectal administration. Each 100 g contains 96 g barium sulfate. Barium sulfate, due to its high molecular density, is opaque to x-rays and therefore acts as a positive contrast agent for radiographic studies. The active ingredient is barium sulfate and its structural formula is BaSO4. Barium sulfate occurs as a fine, white, odorless, tasteless, bulky powder which is free from grittiness. Its aqueous suspensions are neutral to litmus. It is practically insoluble in water, acidic or alkaline solutions, and organic solvents. Excipients: citric acid, pectin, polysorbate 80, simethicone, sodium citrate, sorbitol, tragacanth.

Barium sulfate, due to its high molecular density, is opaque to x-rays and therefore acts as a positive contrast agent for radiographic studies. Barium sulfate is biologically inert and, therefore, is not absorbed or metabolized by the body, and is eliminated unchanged from the body.

This product should not be used in patients with known or suspect-ed colonic perforation, toxic megacolon, recent rectal surgery or radiotherapy to the rectum or prostate, or hypersensitivity to barium sulfate or any component of this barium sulfate formu-lation. It should also not be used within six days of large forceps or “hot” colonic biopsy or a snare polypectomy.

On rare occasions following repeated administration, severe stomach cramps, nausea, vomiting, diarrhea or constipation may occur. These are transitory in nature and are not considered serious. Symptoms may be treated according to currently accepted standards of medical care.

Polibar® ACB Disposable Barium Enema Kit with Rigid Tip is supplied in the following quantity:
397 g Bag; Cat. No. AP14, NDC 32909-804-01
454 g Bag; Cat No. AP16, NDC 32909-804-02

Manufactured by
E-Z-EM Canada Inc.
for E-Z-EM, Inc.
a subsidiary of Bracco Diagnostics Inc.
Monroe Township, NJ 08831
Tel : 1-516-333-8230    1-800 544-4624

POLIBAR® ACB Barium Sulfate 96% w/w
Prefilled Disposable Barium Enema Kit
NDC:32909-804-01