Propylthiouracil Oral tablet

What is this medicine?

PROPYLTHIOURACIL (PTU) (proe pill thye oh YOOR a sill) lowers the amount of thyroid hormone made by the thyroid gland. It treats hyperthyroidism (where the thyroid gland makes too much hormone). It also is used before thyroid surgery or radioactive iodine treatment.

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:

• blood disease

• liver disease

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

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth. Follow the directions on the prescription label. Take your doses at regular intervals. Do not take your medicine 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. While this drug may be prescribed for children as young as 6 years of age for selected conditions, precautions do apply.

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?

• amiodarone

• digoxin

• potassium iodide

• propranolol

• sodium iodide

• theophylline

• thyroid hormones, such as levothyroxine

• 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. It may take time for your condition to improve. You will need tests to check your blood counts and to make sure your body is making the right amount of thyroid hormone.

If you are going to have surgery or dental surgery, tell your doctor, dentist, or health care professional that you are taking this medicine.

This medicine may lower your blood counts and lower your resistance to infection. Contact your doctor or health care professional if you have symptoms of an infection. Do not treat yourself for fever or sore throat. Check before receiving any vaccines.

While this medicine is sometimes used during pregnancy, side effects are possible in the unborn infant. Careful monitoring is needed. This medicine does pass to breast milk. Side effects in a breast-feeding infant are possible. Talk to your doctor or pharmacist for more information.

This medicine may cause serious liver problems. Contact your doctor or health care professional if you have flu-like symptoms, dark urine, light-colored stools, right upper belly pain, or yellowing of the eyes or skin.

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

• goiter (enlarged thyroid gland causing swelling in the throat)

• low blood counts - this medicine may decrease the number of white blood cells. You may be at increased risk for infection

• mouth sores

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

• signs of infection - fever or chills, cough, sore throat

• 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

• swelling of the ankles or legs

• unusual bleeding or bruising

• unusual or sudden weight gain

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

• drowsiness

• changes in taste

• headache

• joint pain

• muscle pain

• nausea

• pain, tingling, numbness in the hands or feet

• upset stomach

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 heat and moisture. Keep tightly closed. Throw away any unused medicine after the expiration date.