TERIFLUNOMIDE- teriflunomide tablet, film coated
Amneal Pharmaceuticals NY LLC
Teriflunomide (ter” i floo’ noe mide) Tablets
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 are teriflunomide tablets?
Teriflunomide tablets are a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease in adults.
It is not known if teriflunomide tablets are safe and effective in children.
Who should not take teriflunomide tablets?
Do not take teriflunomide if you:
What should I tell my doctor before taking teriflunomide tablets?
Before you take teriflunomide tablets, tell your doctor if you:
Tell your doctor about all the medicines you take, including prescription and non-prescription 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:
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:
Tell your doctor if you have any side effect that bothers you or that does not go away.
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 1-800-332-1088.
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.
This Medication Guide summarizes the most important information about teriflunomide tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about teriflunomide tablets that is written for healthcare professionals.
For more information, go to www.amneal.com or call Amneal Pharmaceuticals at 1-877-835-5472.
What are the ingredients in teriflunomide tablets?
Active ingredient: teriflunomide
Inactive ingredients in 7 mg and 14 mg tablets: corn starch, hydroxypropyl cellulose, lactose monohydrate, microcrystalline cellulose, magnesium stearate and sodium starch glycolate. The film coating for the 7 mg and 14 mg tablet is made of colloidal anhydrous silica, FD & C Blue # 2/indigo carmine aluminum lake, hypromellose, polyethylene glycol, titanium dioxide and in addition to these, the 7 mg tablet film coating includes iron oxide yellow.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Amneal Pharmaceuticals Pvt. Ltd.
Oral Solid Dosage Unit
Ahmedabad 382213, INDIA
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807