Crofelemer is used in adults to treat diarrhea that may be caused by taking antiviral medicine to treat HIV (human immunodeficiency virus). Crofelemer is not for use in treating diarrhea that is caused by an infection.

Crofelemer is not a treatment for HIV.

Crofelemer may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before you start treatment with crofelemer, your doctor may perform medical tests to make sure you do not have infectious diarrhea.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Swallow the tablet whole and do not crush, chew, or break it.

You may take crofelemer with or without food.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Diarrhea:

125 mg orally twice daily

Use: For symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy:

Tell your doctor if you are sick with diarrhea and vomiting or other symptoms of infection.

It is not known whether crofelemer will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Women with HIV or AIDS should not breastfeed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Crofelemer is not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unless your doctor tells you otherwise, continue your normal diet.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Crofelemer may cause serious side effects. Call your doctor at once if you have:

• dark urine, jaundice (yellowing of the skin or eyes);

• wheezing, chest tightness, trouble breathing; or

• worsening diarrhea.

Common side effects of crofelemer may include:

• abnormal blood tests;

• gas; or

• cold symptoms such as stuffy nose, sneezing, cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.