Crofelemer

Crofelemer is used to control some types of diarrhea in patients with human immunodeficiency virus (HIV) infection who are being treated with certain medications. Crofelemer is in a class of medications called botanicals. It works by decreasing the amount of fluid that flows into the bowel that can cause diarrhea.

Crofelemer comes as a delayed-release (releases the medication in the intestine where its effects are needed) tablet to take by mouth. It is usually taken two times a day, with or without food. Take crofelemer at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take crofelemer exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not chew or crush them.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking crofelemer,

• tell your doctor and pharmacist if you are allergic to crofelemer, any other medications, or any of the ingredients in crofelemer tablets. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking crofelemer, call your doctor.

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

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Crofelemer may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• runny nose, sneezing, or cough
• tiredness, fever, chills, cough with mucus (sputum), or chest tightness
• gas
• nausea
• swelling of the abdomen
• hemorrhoids
• back or joint pain
• difficult, painful, or frequent urination
• urine that is cloudy or discolored
• back pain or pressure in the lower abdomen
• anxiety

Crofelemer may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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 (https://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. https://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

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.

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