PROPYLTHIOURACIL- propylthiouracil tablet 
Actavis Pharma, Inc.

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Medication Guide

PROPYLTHIOURACIL (proe" pil thye" oh ure' a sil) TABLETS

Rx only

Read this Medication Guide before you start taking propylthiouracil tablets 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 tablets?

Propylthiouracil tablets can cause serious side effects, including:

• Severe liver problems. In some cases, liver problems can happen in people who take propylthiouracil tablets including: liver failure, the need for liver transplant, or death. Stop taking propylthiouracil tablets and call your doctor right away if you have any of these symptoms:

• Serious risks during pregnancy. Propylthiouracil may cause liver problems, liver failure and death in pregnant women and may harm your unborn baby. Propylthiouracil may also cause liver problems or death of infants born to women who take propylthiouracil during certain trimesters of pregnancy. Propylthiouracil may be used when an antithyroid drug is needed during or just before the first trimester of pregnancy.

If you get pregnant while taking propylthiouracil tablets, call your doctor right away about your therapy.

What are propylthiouracil tablets?

Propylthiouracil tablets are a prescription medicine used to treat people who have Graves’ disease with hyperthyroidism or toxic multinodular goiter. Propylthiouracil tablets are used when:

Propylthiouracil tablets are not recommended for use in children.

Who should not take propylthiouracil tablets?

Do not take propylthiouracil tablets 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 tablets.

What should I tell my doctor before taking propylthiouracil tablets?

Before you take propylthiouracil tablets, tell your doctor if you:

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

Especially, tell your doctor if you take:

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 tablets?

 

What should I avoid while taking Propylthiouracil tablets?

Propylthiouracil can cause dizziness, drowsiness or sleepiness. If you have these symptoms do not drive, operate machinery, or do other dangerous activities until you know how propylthiouracil affects you.

 

What are the possible side effects of propylthiouracil tablets?

Propylthiouracil tablets may cause serious side effects, including:

The most common side effects of propylthiouracil tablets include:

 • nausea • muscle pain
 • vomiting • headache
 • upper stomach pain or tenderness • sleepiness
 • joint pain • nerve pain
 • itching or tingling • swelling (edema)
 • loss or change in taste • dizziness
 • loss of hair  • 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 tablets. 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 tablets?

Keep propylthiouracil tablets and all medicines out of the reach of children.

General information about the safe and effective use of propylthiouracil tablets:

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.

Do not use propylthiouracil tablets for a condition for which they were not prescribed.

Do not give propylthiouracil tablets to other people, even if they have the same symptoms that you have. They may harm them.

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

For more information call Actavis at 1-800-432-8534.

What are the ingredients in propylthiouracil tablets?

Active ingredient: propylthiouracil

Inactive ingredients: lactose monohydrate, corn starch, colloidal silicon dioxide, povidone, pregelatinized corn starch, and magnesium stearate.

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

Brands listed are the trademarks of their respective owners.

Manufactured by:
Actavis Elizabeth LLC
Elizabeth, NJ 07207 USA

Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Rev. A 12/2018

40-9158

(MG 41-1168/1218)

Revised: 12/2018
Actavis Pharma, Inc.