TERIFLUNOMIDE- teriflunomide tablet 
Breckenridge Pharmaceutical, Inc.

----------

Medication Guide

Teriflunomide (ter i FLOO noe mide) tablets, for oral use

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

What is the most important information I should know about teriflunomide tablets?
Teriflunomide tablets may cause serious side effects, including:

Call your doctor right away if you have any of the following symptoms of liver problems:

  • nausea
  • stomach pain
  • tiredness
  • dark urine
  • vomiting
  • loss of appetite
  • your skin or the whites of your eyes turn yellow

Teriflunomide may stay in your blood for up to 2 years after you stop taking it. Your doctor can prescribe a medicine to help lower your blood levels of teriflunomide more quickly. Talk to your doctor if you want more information about this.

What are teriflunomide tablets?

Who should not take teriflunomide tablets?
Do not take teriflunomide tablets if you:

What should I tell my doctor before taking teriflunomide tablets?

Before you take teriflunomide tablets, tell your doctor about all of your medical conditions, including if you:

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Using teriflunomide tablets and other medicines may affect each other causing serious side effects. Teriflunomide tablets may affect the way other medicines work, and other medicines may affect how teriflunomide tablets works.

Especially tell your doctor if you take medicines that could raise your chance of getting infections, including medicines used to treat cancer or to control your immune system.

Ask your doctor or pharmacist for a list of these medicines if you are not sure.

Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine.

How should I take teriflunomide tablets?

What are possible side effects of teriflunomide tablets?

Teriflunomide tablets may cause serious side effects, including:

  • severe muscle pain
  • swelling of your face
  • weakness or tiredness
  • swollen lymph glands
  • unusual bruising or bleeding
  • yellowing of your skin or the white part of your eyes

If you have a fever or rash with any of the above symptoms, stop taking Teriflunomide Tablets and call your doctor right away.

Tell your doctor if you have numbness or tingling in your hands or feet that is different from your MS.

The most common side effects of teriflunomide tablets include:

  • headache
  • nausea
  • increases in the results of blood tests to check your liver function
  • diarrhea
  • hair thinning or loss (alopecia)

These are not all the possible side effects of teriflunomide 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 teriflunomide tablets?

General information about the safe and effective use of teriflunomide tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use teriflunomide tablets for a condition for which it was not prescribed. Do not give teriflunomide tablets to other people, even if they have the same symptoms you have. It may harm them.

You can ask your doctor or pharmacist for information about Teriflunomide Tablets that is written for health professionals.

For more information, go to www.bpirx.com or call Breckenridge Pharmaceutical, Inc. at 1-800-367-3395

What are the ingredients in teriflunomide tablets?

Active ingredient: teriflunomide

Inactive ingredients in 7 mg and 14 mg tablets: lactose monohydrate, corn starch, hydroxypropyl cellulose, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, hypromellose, titanium dioxide, talc and polyethylene glycol.

In addition, the 7 mg tablets also contain iron oxide yellow.

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

Manufactured by:
Centaur Pharmaceuticals Pvt. Ltd.
Pune - 411057, Maharashtra, India

Distributed by:
Breckenridge Pharmaceutical Inc.
Berlin, CT 06037

Issued: 06/2022

212137

Revised: 12/2022
Breckenridge Pharmaceutical, Inc.