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ELETRIPTAN- eletriptan hydrobromide tablet, film coated


  1. Eletriptan Can Cause Serious Side Effects, Including:
  2. Stop Taking Eletriptan And Get Emergency Medical Help Right Away If You Have Any Of The Following Symptoms Of A Heart Attack:
  3. Eletriptan Is 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:
  4. Call Your Doctor Right Away If You Have Any Of The Following Symptoms Of Serotonin Syndrome:
  5. Who Should Not Take Eletriptan?
  6. Before You Take Eletriptan, Tell Your Doctor If You:
  7. How Should I Take Eletriptan?
  8. What Should I Avoid While Taking Eletriptan?
  9. What Are The Possible Side Effects Of Eletriptan?
  10. What Are The Ingredients In Eletriptan?
  11. Patient Information

Eletriptan Can Cause Serious Side Effects, Including: 

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

Stop Taking Eletriptan And Get Emergency Medical Help Right Away If You Have Any Of The Following Symptoms Of A Heart Attack: 

  • discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
  • chest pain or chest discomfort that feels like an uncomfortable heavy pressure, squeezing, fullness, or pain
  • pain or discomfort in your arms, back, neck, jaw, or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded

Eletriptan Is 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: 

  • have high blood pressure
  • have high cholesterol levels
  • smoke
  • are overweight
  • have diabetes
  • have a family history of heart disease
  • are a female who has gone through menopause
  • are a male over age 40

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

  • mental changes such as

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

    Eletriptan is for people who have been diagnosed with migraine headaches.

    Eletriptan is not used to prevent or decrease the number of migraine headaches you have.

    It is not known if eletriptan is safe and effective to treat cluster headaches.

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

Who Should Not Take Eletriptan? 

Donottake eletriptan if you:

  • have heart problems or a history of heart problems
  • have or have had a stroke or problems with your blood circulation
  • have hemiplegic or basilar migraines. If you are not sure if you have these types of migraines, ask your doctor
  • have narrowing of the blood vessels in your legs, arms, stomach, or kidney (peripheral vascular disease)
  • have ischemic bowel disease
  • have uncontrolled high blood pressure
  • have taken any of the following medicines in the last 24 hours:
    • other "triptans" or triptan combination products such as:
      • almotriptan (Axert)
      • frovatriptan (Frova)
      • naratriptan (Amerge)
      • rizatriptan (Maxalt)
      • sumatriptan (Imitrex)
      • sumatriptan and naproxen sodium, (Treximet)
      • zolmitriptan (Zomig)
    • ergotamines such as:
      • Bellergal-S
      • Ergomar
      • Cafergot
      • Wigraine
    • dihydroergotamines such as:
      • D.H.E. 45or Migranalor methysergide (Sansert)
  • have taken the following medicines within the last 72 hours:
    • ketoconazole (Nizoral)
    • itraconazole (Sporanox)
    • nefazodone (Serzone)
    • troleandomycin (TAO)
    • clarithromycin (Biaxin)
    • ritonavir (Norvir)
    • nelfinavir (Viracept)
  • are allergic to eletriptan or any of the ingredients in eletriptan.

Before You Take Eletriptan, Tell Your Doctor If You: 

  • have heart problems or family history of heart problems or stroke
  • have high blood pressure
  • have high cholesterol
  • have diabetes
  • smoke
  • are overweight
  • are a female who has gone through menopause
  • have kidney problems
  • have liver problems
  • are pregnant or plan to become pregnant. It is not known if eletriptan will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. Eletriptan passes into your breast milk and may harm your baby. Talk to your doctor about the best way to feed your baby if you take eletriptan.

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 with your other medicines. Eletriptan and other medicines may affect each other causing side effects.

Especially tell your doctor if youtake anti-depressant medicines called:

  • selective serotonin reuptake inhibitors (SSRIs)
  • serotonin and norepinephrine reuptake inhibitors (SNRIs)

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? 

  • Take eletriptan exactly as your doctor tells you to take it.
  • Your doctor will tell you how much eletriptan to take and when to take it.
  • Your doctor may change your dose if needed. Do not change your dose without first talking to your doctor.
  • Take 1 eletriptan tablet as soon as you feel a migraine coming on.
  • If you do not get any relief after your first eletriptan tablet, do not take a second tablet without first talking with your doctor.
  • If your headache comes back or you only get some relief from your headache, you can take a second tablet 2 hours after the first tablet.
  • Do not take more than a total of 80 mg of eletriptan tablets in a 24-hour period.
  • If you take too much eletriptan, call your doctor or go to the nearest hospital emergency room right away.
  • You should write down when you have headaches and when you take eletriptan so you can talk to your doctor about how well eletriptan is working for you.

What Should I Avoid While Taking Eletriptan? 

Eletriptan 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? 

Eletriptan may cause serious side effects.

  • Store eletriptan at room temperature between 68 F to 77 F (20 C to 25 C).

General information about the safe and effective use of eletriptan

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use eletriptan for a condition for which it was not prescribed. Do not give eletriptan 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. If you would like more information about eletriptan, talk with your doctor. You can ask your doctor or pharmacist for information on eletriptan that is written for health professionals.

For more information go to http://www.greenstonellc.comor call 1-800-438-1985.

What Are The Ingredients In Eletriptan? 

Active ingredient: eletriptan hydrobromide

Inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, titanium dioxide, hypromellose, triacetin, and FD&C Yellow No. 6 aluminum lake.

All brands are trademarks of their owners.

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

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LAB-0778-1.0

April 2016

Patient Information 

SeeFDA Approved Patient Labeling (Patient Information)

Myocardial Ischemia and/or Infarction, Prinzmetal's Angina, Other Vasospastic Reactions, and Cerebrovascular Events

Inform patients that eletriptan may cause serious cardiovascular adverse reactions such as myocardial infarction or stroke, which may result in hospitalization and even death. Although serious cardiovascular reactions can occur without warning symptoms, instruct patients to be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and instruct them to ask for medical advice when observing any indicative sign or symptoms. Instruct patients to seek medical advice if they have symptoms of other vasospastic reactions[seeWarnings and Precautions (5.1,5.2,5.4,5.5, and5.8)].

Anaphylactic/Anaphylactoid Reactions

Inform patients that anaphylactic/anaphylactoid reactions have occurred in patients receiving eletriptan. Such reactions can be life threatening or fatal. In general, anaphylactic reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens[seeContraindications (4)].

Medication Overuse Headache

Inform patients that use of drugs to treat acute migraines for 10 or more days per month may lead to an exacerbation of headache, and encourage patients to record headache frequency and drug use (e.g., by keeping a headache diary)[seeWarnings and Precautions (5.6)].

Serotonin Syndrome

Inform patients about the risk of serotonin syndrome with the use of eletriptan or other triptans, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs)[seeWarnings and Precautions (5.7)andDrug Interactions (7.3)].

Pregnancy

Inform patients that eletriptan should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus[seeUse in Specific Populations (8.1)].

Nursing Mothers

Inform patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed[seeUse in Specific Populations (8.3)].

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LAB-0777-1.0



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