MEDICATION GUIDE

PROPYLTHIOURACIL TABLETS, USP (Pro-pil-thi-o-ur-a-sil)

Read this Medication Guide before you start taking Propylthiouracil and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment.

What is the most important information I should know about Propylthiouracil?
Propythiouracil can cause serious side effects, including:
Severe liver problems. In some cases, these liver problems can lead to liver failure, the need for liver transplant, or death.

Stop taking Propylthiouracil and call your doctor right away if you have:

• fever
• loss of appetite
• nausea
• vomiting
• tiredness
• itchiness
• pain or tenderness in your right upper stomach area (abdomen)
• dark (tea colored) urine
• pale or light colored bowel movements (stools)
• yellowing of your skin or whites of your eyes

What is Propylthiouracil?
Propylthiouracil is a prescription medicine used to treat people who have Graves' disease with hyperthyroidism or toxic multinodular goiter. Propylthiouracil is used when:

• certain other antithyroid medicines do not work well.
• thyroid surgery or radioactive iodine therapy is not a treatment option.
• to decrease symptoms of hyperthyroidism in preparation for a thyroidectomy (removal of the thyroid gland) or radioactive iodine therapy.

Propylthiouracil is not recommended for use in children.

Propylthiouracil may be used when an antithyroid drug is needed during or just before the first trimester of pregnancy.

Who should not take Propylthiouracil?
Do not take Propylthiouracil if you are allergic to Propylthiouracil or any of its ingredients. See the end of this Medication Guide for a complete list of ingredients in Propylthiouracil.

What should I tell my doctor before taking Propylthiouracil?
Before you take Propylthiouracil, tell your doctor if you:

• plan to have surgery.
• have any other medical conditions.
• are pregnant or plan to become pregnant.
  • Propylthiouracil may cause liver problems, liver failure and death in pregnant women.
  • Propylthiouracil may harm your unborn baby.
• are breast-feeding or plan to breast-feed. Propylthiouracil can pass into your breast milk. Talk to you doctor about the best way to feed your baby if you take Propylthiouracil.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Propylthiouracil may affect the way other medicines work.

Especially, tell your doctor if you take:

• a blood thinner medicine warfarin sodium (Coumadin, Jantoven)
• medicine for heart problems
• medicine for high blood pressure
• Digoxin (Lanoxicaps, Lanoxin)
• Theophylline (Elixophyllin, Theolair, Theochron, Theo-24, Uniphyl)

Ask your doctor if you are not sure if your medicine is one of these.
Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I take Propylthiouracil?

• Take Propylthiouracil exactly as your doctor tells you to take it.
• Your doctor may change your dose if needed.
• Propylthiouracil is usually taken 3 times a day (every 8 hours).
• If you take too much Propylthiouracil, call your Regional Poison Control Center or go to the nearest hospital emergency room right away.
• If you take too much Propylthiouracil you may have the following symptoms:
  • nausea
  • vomiting
  • upper stomach pain or tenderness
  • headache
  • fever
  • joint pain
  • swelling of your body, arms, and legs
• If you miss a dose of Propylthiouracil, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Just take the next dose at your regular time. Do not double your dose.

What are the possible side effects of Propylthiouracil?
Propylthiouracil may cause serious side effects, including:

• liver problems. See "What is the most important information I should know about Propylthiouracil?"
• low white blood cell counts. This usually happens within the first 3 months of treatment and can be life-threatening. You may have a higher chance of getting an infection when your white blood cell count is low.

Tell your doctor right away if you have:

• a fever
• chills
• sore throat
• hypothyroidism. Your doctor should do blood tests regularly during treatment to check your thyroid.
• increased bleeding especially with surgical procedures and particularly if you are taking blood thinners.

The most common side effects of Propylthiouracil include:

• skin rash or hives
• nausea
• vomiting
• upper stomach pain or tenderness
• joint pain
• itching or tingling
• loss or change in taste
• loss of hair
• muscle pain
• headache
• sleepiness
• nerve pain
• swelling (edema)
• dizziness
• enlarged salivary glands or enlarged lymph nodes

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of Propylthiouracil. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Propylthiouracil?
Store at 20-25ºC (68-77ºF) [See USP Controlled Room Temperature].
Keep Propylthiouracil and all medicines out of the reach of children.

General information about the sale and effective use of Propylthiouracil:
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.

Do not use Propylthiouracil for a condition for which it was not prescribed.
Do not give Propylthiouracil to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about Propylthiouracil. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Propylthiouracil that is written for health professionals.

West-ward Pharmaceutical Corp.
www.west-ward.com
1-877-233-2001

What are the ingredients in Propylthiouracil?
Active ingredient: propylthiouracil
Inactive ingredients: anhydrous lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate.

West-ward Pharmaceutical Corp.
Eatontown, NJ 07724 USA

This Medication Guide has been approved by the U.S. Food and Drug Administration.
04/2010