ELETRIPTAN HYDROBROMIDE- eletriptan hydrobromide tablet, film coated 
Zydus Pharmaceuticals (USA) Inc.

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Patient Information

Eletriptan hydrobromide (el-e-TRIP-tan HYE-droe-BROE-mide) Tablets

Please read this information before you start taking eletriptan hydrobromide 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 eletriptan hydrobromide tablets?

Eletriptan hydrobromide tablets can cause serious side effects, including:

Heart attack and other heart problems. Heart problems may lead to death.

Stop taking eletriptan hydrobromide tablets and get emergency medical help right away if you have any of the following symptoms of a heart attack:

Eletriptan hydrobromide tablets are not for people with risk factors for heart disease unless a heart exam is done and shows no problem. You have a higher risk for heart disease if you:

Serotonin syndrome. Serotonin syndrome is a serious and life-threatening problem that can happen in people taking eletriptan hydrobromide tablets, especially if eletriptan hydrobromide tablets is taken with anti-depressant medicines called selective serotonin reuptake inhibitors (SSRIs) or selective norepinephrine reuptake inhibitors (SNRIs).

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

Call your doctor right away if you have any of the following symptoms of serotonin syndrome:

What is eletriptan hydrobromide tablets?

Eletriptan hydrobromide tablets are a prescription medicine used to treat acute migraine headaches with or without aura in adults.

Eletriptan hydrobromide tablets are for people who have been diagnosed with migraine headaches.

Eletriptan hydrobromide tablets are not used to prevent or decrease the number of migraine headaches you have. It is not known if eletriptan hydrobromide tablets is safe and effective to treat cluster headaches.

It is not known if eletriptan hydrobromide tablets are safe and effective in children.

Who should not take eletriptan hydrobromide tablets?

Do not take eletriptan hydrobromide tablets if you:

What should I tell my doctor before taking eletriptan hydrobromide tablets?

Before you take eletriptan hydrobromide 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. Your doctor will decide if you can take eletriptan hydrobromide tablets with your other medicines. Eletriptan hydrobromide tablets and other medicines may affect each other causing side effects.

Especially tell your doctor if you take anti-depressant medicines called:

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 eletriptan hydrobromide tablets?

What should I avoid while taking eletriptan hydrobromide tablets?

Eletriptan hydrobromide tablets can cause dizziness, weakness, or drowsiness. If you have these symptoms, do not drive a car, use machinery, or do anything where you need to be alert.

What are the possible side effects of eletriptan hydrobromide tablets?

Eletriptan hydrobromide tablets may cause serious side effects. See "What is the most important information I should know about eletriptan hydrobromide tablets?"

These serious side effects include:

Symptoms of gastrointestinal and colonic ischemic events include:

Symptoms of peripheral vascular ischemia include:

The most common side effects of eletriptan hydrobromide 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 eletriptan hydrobromide 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 eletriptan hydrobromide tablets?

General information about the safe and effective use of eletriptan hydrobromide tablets

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use eletriptan hydrobromide tablets for a condition for which it was not prescribed. Do not give eletriptan hydrobromide tablets to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information summarizes the most important information about eletriptan hydrobromide tablets. If you would like more information about eletriptan hydrobromide tablets, talk with your doctor. You can ask your doctor or pharmacist for information on eletriptan hydrobromide tablets that is written for health professionals.

Please address medical inquiries to, (MedicalAffairs@zydususa.com) Tel.: 1-877-993-8779.

What are the ingredients in eletriptan hydrobromide tablet?

Active ingredient: eletriptan hydrobromide

Inactive ingredients: anhydrous lactose, croscarmellose sodium, FD & C Yellow No. #6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, titanium dioxide and triacetin. Additionally, each 20 mg tablet contains D & C Yellow #10 aluminum lake and FD & C Blue #2 aluminum lake and each 40 mg tablet contains ferric oxide yellow and ferric oxide red.

*All Product/Brand names are the trademarks of their respective owners.

This product's label may have been updated. For current full prescribing information, please visit www.zydususa.com.

Manufactured by:

Cadila Healthcare Ltd.

Ahmedabad, India

Distributed by:

Zydus Pharmaceuticals USA Inc.

Pennington, NJ 08534

Rev.: 05/16

Revised: 11/2019
Zydus Pharmaceuticals (USA) Inc.