Leflunomide Oral tablet

What is this medicine?

LEFLUNOMIDE (le FLOO na mide) is for rheumatoid arthritis.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

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

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

• alcoholism

• bone marrow problems

• fever or infection

• immune system problems

• kidney disease

• liver disease

• an unusual or allergic reaction to leflunomide, teriflunomide, other medicines, lactose, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a full glass of water. Follow the directions on the prescription label. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

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

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

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.

What may interact with this medicine?

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

• teriflunomide

This medicine may also interact with the following medications:

• charcoal

• cholestyramine

• methotrexate

• NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen

• phenytoin

• rifampin

• tolbutamide

• vaccines

• warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. You will need frequent blood checks while you are receiving the medicine.

If you get a cold or other infection while receiving this medicine, call your doctor or health care professional. Do not treat yourself. The medicine may increase your risk of getting an infection.

If you are a woman who has the potential to become pregnant, discuss birth control options with your doctor or health care professional. You must not be pregnant, and you must be using a reliable form of birth control. The medicine may harm an unborn baby. Immediately call your doctor if you think you might be pregnant.

Alcoholic drinks may increase possible damage to your liver. Do not drink alcohol while taking this medicine.

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

• cough

• difficulty breathing or shortness of breath

• fever, chills or any other sign of infection

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• unusual bleeding or bruising

• unusually weak or tired

• vomiting

• yellowing of eyes or skin

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

• diarrhea

• hair loss

• headache

• nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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). Protect from moisture and light. Throw away any unused medicine after the expiration date.