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ELETRIPTAN HYDROBROMIDE tablet, film coated


  1. Eletriptan Hydrobromide Tablets Can Cause Serious Side Effects, Including:
  2. Other Triptans Or Triptan Combination Products Such As:
  3. Ergotamines Such As:
  4. Dihydroergotamines Such As:
  5. Have Taken The Following Medicines Within The Last 72 Hours:
  6. What Should I Avoid While Taking Eletriptan Hydrobromide Tablets?
  7. What Are The Possible Side Effects Of Eletriptan Hydrobromide Tablets?
  8. Manufactured In Canada By:
  9. Manufactured For:
  10. N Cause Serious Side Effects, Including:
  11. P Taking Eletriptan Hydrobromide Tablets And Get Emergency Medical Help Right Away If You Have Any Of The Following Symptoms Of A Heart Attack:
  12. Call Your Doctor Right Away If You Have Any Of The Following Symptoms Of Serotonin Syndrome:
  13. O Should Not Take Eletriptan Hydrobromide Tablets?
  14. O Not Take Eletriptan Hydrobromide Tablets If You:
  15. Other "triptans" Or Triptan Combination Products Such As:
  16. Have Taken The Following Medicines Within The Last 72 Hours:
  17. Before You Take Eletriptan Hydrobromide Tablets, Tell Your Doctor If You:
  18. W Should I Take Eletriptan Hydrobromide Tablets?
  19. T Should I Avoid While Taking Eletriptan Hydrobromide Tablets?
  20. T Are The Possible Side Effects Of Eletriptan Hydrobromide Tablets?
  21. Manufactured By:
  22. Distributed By:
  23. Patient Information
  24. Stop Taking Eletriptan Hydrobromide Tablets And Get Emergency Medical Help Right Away If You Have Any Of The Following Symptoms Of A Heart Attack:
  25. 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:
  26. Who Should Not Take Eletriptan Hydrobromide Tablets?
  27. How Should I Take Eletriptan Hydrobromide Tablets?
  28. What Are The Ingredients In Eletriptan Hydrobromide Tablets?
  29. Myocardial Ischemia And/or Infarction, Prinzmetal S Angina, Other Vasospastic Reactions, And Cerebrovascular Events:
  30. Anaphylactic/anaphylactoid Reactions:
  31. Medication Overuse Headache:
  32. Serotonin Syndrome:
  33. Pregnancy:
  34. Nursing Mothers:

Eletriptan Hydrobromide Tablets Can Cause Serious Side Effects, Including: 

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

Other Triptans Or Triptan Combination Products Such As: 

  • almotriptan (Axert)
  • sumatriptan and naproxen sodium (Treximet )
  • frovatriptan (FrovaTM)
  • zolmitriptan (Zomig)
  • naratriptan (Amerge)
  • rizatriptan (Maxalt)
  • sumatriptan (Imitrex)

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)
  • clarithromycin (Biaxin)
  • itraconazole (Sporanox)
  • ritonavir (Norvir)
  • nefazodone (Serzone)
  • nelfinavir (Viracept)
  • troleandomycin (TAO)
  • are allergic to eletriptan or any of the ingredients in 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.

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

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 they were not prescribed. Do not give eletriptan hydrobromide tablets to other people, even if they have the same symptoms you have. They 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.

For more information, call 1-888-838-2872.

Manufactured In Canada By: 

TEVA CANADA LIMITED

Toronto, Canada M1B 2K9

Manufactured For: 

TEVA PHARMACEUTICALS USA, INC.

North Wales, PA 19454

Iss. 4/2016

N Cause Serious Side Effects, Including: 

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

Sto

P Taking Eletriptan Hydrobromide Tablets 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 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:

  • 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 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: 

  • mental changes such as

    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.

    Wh

O Should Not Take Eletriptan Hydrobromide Tablets? 

D

O Not Take Eletriptan Hydrobromide Tablets 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

Other "triptans" Or Triptan Combination Products Such As: 

  • almotriptan (Axert*)
  • sumatriptan and naproxen sodium, (Treximet *)
  • frovatriptan (FrovaTM*)
  • naratriptan (Amerge*)
  • zolmitriptan (Zomig*)
  • rizatriptan (Maxalt*)
  • sumatriptan (Imitrex*)
  • Have Taken The Following Medicines Within The Last 72 Hours: 

  • ketoconazole (Nizoral*)
  • clarithromycin (Biaxin*)
  • itraconazole (Sporanox*)
  • ritonavir (Norvir*)
  • nefazodone (Serzone*)
  • nelfinavir (Viracept*)
  • troleandomycin (TAO*)
  • are allergic to eletriptan or any of the ingredients in eletriptan hydrobromide tablets.

  • Before You Take Eletriptan Hydrobromide Tablets, 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 hydrobromide will harm your unborn baby.
    • are breastfeeding or plan to breastfeed. Eletriptan hydrobromide passes into your breastmilk and may harm your baby. Talk to your doctor about the best way to feed your baby if you take eletriptan hydrobromide tablets.

    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 youtake anti-depressant medicines called:

    • selective serotonin reuptake inhibitors (SSRIs)
    • serotonin 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.

    Ho

    W Should I Take Eletriptan Hydrobromide Tablets? 

    • Take eletriptan hydrobromide tablets exactly as your doctor tell you to take it.
    • Your doctor will tell you how much eletriptan hydrobromide tablets 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 hydrobromide tablets as soon as you feel a migraine coming on.
    • If you do not get any relief after your first eletriptan hydrobromide tablets, 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 hydrobromide tablets in a 24-hour period.
    • If you take too much eletriptan hydrobromide tablets, 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 hydrobromide tablets so you can talk to your doctor about how well eletriptan hydrobromide tablets is working for you.

    Wha

    T 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.

    Wha

    T Are The Possible Side Effects Of Eletriptan Hydrobromide Tablets? 

    Eletriptan hydrobromide tabletsmay cause serious side effects.

    • Store eletriptan hydrobromide tablets at 20 to 25 C (68 to 77 F) [

      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

    Patient Information 

    Eletriptan Hydrobromide Tablets
    (el e trip tan hye droe broe mide)

    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.

    Stop Taking Eletriptan Hydrobromide Tablets 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 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: 

    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 hydrobromide tablets, especially if eletriptan hydrobromide tablets are taken with antidepressant 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.

    Who Should Not Take Eletriptan Hydrobromide Tablets? 

    Donottake eletriptan hydrobromide tablets 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

    How Should I Take Eletriptan Hydrobromide Tablets? 

    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 one eletriptan hydrobromide tablet as soon as you feel a migraine coming on.
    If you do not get any relief after your first eletriptan hydrobromide 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 hydrobromide 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 hydrobromide tablets so you can talk to your doctor about how well eletriptan hydrobromide tablets are working for you.

    What Are The Ingredients In Eletriptan Hydrobromide Tablets? 

    Active ingredient: eletriptan hydrobromide

    Inactive ingredients: anhydrous lactose, croscarmellose sodium, FD&C Yellow No. 6 Aluminum Lake, lecithin, microcrystalline cellulose, magnesium stearate, polyvinyl alcohol, talc, titanium dioxide and xanthan gum.

    The brands listed are trademarks of their respective owners.

    Manufactured for:
    Mylan Pharmaceuticals Inc.
    Morgantown, WV 26505 U.S.A.

    Manufactured in India by:
    Mylan Laboratories Limited
    Hyderabad 500 096, India

    Revised: 12/2018
    75066915
    MXA:ELET:R2U

    Myocardial Ischemia And/or Infarction, Prinzmetal S Angina, Other Vasospastic Reactions, And Cerebrovascular Events: 

    Inform patients that eletriptan hydrobromide tablets 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 hydrobromide tablets. 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 hydrobromide tablets or other triptans, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs)[seeWarnings and Precautions (5.7)andDrug Interactions (7.3)].

    Pregnancy: 

    Inform patients that eletriptan hydrobromide tablets 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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