Obeticholic Acid tablets

What is this medicine?

OBETICHOLIC ACID is a bile acid drug. This medicine treats primary biliary cholangitis or cirrhosis.

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin; diarrhea; weight loss; vomiting; change in behavior or confusion; feeling anxious

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• constipation

• dizziness

• fast, irregular heartbeat

• fever

• jaw pain

• joint pain

• stomach pain

• swelling of the ankles, feet, hands

• unusually weak or tired

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• elbasvir; grazoprevir

This medicine may also interact with the following medications:

• caffeine

• certain medicines that treat or prevent blood clots like warfarin

• cholestyramine

• colesevelam

• colestipol

• cyclosporine

• omeprazole

• theophylline

• tizanidine

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• liver disease

• skin conditions or sensitivity

• an unusual or allergic reaction to obeticholic acid, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

You may need blood work done while you are taking this medicine.