TERIFLUNOMIDE- teriflunomide tablet, film coated 
Apotex Corp

----------

Medication Guide

Teriflunomide Tablets, for oral use (ter” i floo’ noe mide)

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:

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 may affect the way other medicines work, and other medicines may affect how teriflunomide 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:

The most common side effects of teriflunomide tablets include:

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.

What are the ingredients in teriflunomide tablets?

Active ingredient: teriflunomide

Inactive ingredients in 7 mg and 14 mg tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, meglumine, and microcrystalline cellulose. The film coating for the tablet is made of FD&C Blue #2 lake 12-14%, ferric oxide yellow (7 mg only), polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

For more information, call Apotex Corp. at 1-800-706-5575 or go to www.apotex.com.

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

APOTEX INC.
TERIFLUNOMIDE TABLETS
7 mg and 14 mg

Manufactured By:Manufactured For:
Apotex Inc.Apotex Corp.
Toronto, OntarioWeston, Florida
Canada M9L 1T9USA 33326

Revised: June 2024

Revision: 10

Revised: 6/2024
Apotex Corp