TERIFLUNOMIDE- teriflunomide tablet, coated 
SOLA Pharmaceuticals, LLC


                                                                                                                                    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:

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 is Teriflunomide Tablet?

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 work.

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:

If you have a fever or rash with any of the above symptoms, stop taking teriflunomide 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:

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 14 mg tablets: lactose monohydrate, hydroxypropylcellulose, microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate. The film coating for the 14 mg tablet is made of titanium dioxide, talcum, hypromellose, cottonseed oil, and FD&C Blue no. 2 Al-Lake.  In addition to these, the 14 mg tablet includes FD&C Red No. 40.

For more information, call Sola Pharmaceuticals at 1 866-747-7365

Mfd. By:
Combino Pharm Ltd.
HF60, Hal Far Industrial Estate
Hal Far, BBG 3000

Distributed by:
Sola Pharmaceuticals, LLC
Baton Rouge, LA 70810

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

Iss.  01/2023

Revised: 8/2023
SOLA Pharmaceuticals, LLC