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FROVATRIPTAN- frovatriptan succinate tablet, film coated


  1. Succinate Tablets Can Cause Serious Side Effects, Including:
  2. Frovatriptan Succinate 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:
  3. F You Have:
  4. Taken Any Of The Following Medicines In The Last 24 Hours:
  5. Before Taking Frovatriptan Succinate Tablets, Tell Your Doctor About All Of Your Medical Conditions, Including If You:
  6. Specially Tell Your Doctor If You Take:
  7. Antidepressant Medicines Called:
  8. Patient Information

Succinate Tablets Can Cause Serious Side Effects, Including: 

  • Heart attack and other heart problems.Heart problems may lead to death. Stop taking frovatriptan succinate 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
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • 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

Frovatriptan Succinate 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
  • smoke
  • have diabetes
  • have high cholesterol levels
  • are overweight
  • have a family history of heart disease

What arefrovatriptansuccinate tablets?

Frovatriptan succinate tablets are a prescription medicine used to treat migraine headaches with or without aura in adults.

Frovatriptan succinate tablets are not used to treat other types of headaches.

Frovatriptan succinate tablets are not used to prevent or decrease the number of migraine headaches.

It is not known if frovatriptan succinate tablets are safe and effective to treat cluster headaches.

It is not known if frovatriptan succinate tablets are safe and effective in children under 18 years of age.

Who should not takefrovatriptansuccinate tablets?

Do not takefrovatriptansuccinate tabletsi

F You Have: 

  • heart problems, a history of heart problems, or problems with the electrical system of your heart.
  • had a stroke, transient ischemic attacks (TIAs), or problems with your blood circulation.
  • had hemiplegic migraines or basilar migraines. If you are not sure if you have had these types of migraines, ask your healthcare provider.
  • narrowing of blood vessels to your legs, arms, or stomach (peripheral vascular disease).
  • injury to your bowel (intestine) due to poor blood circulation (ischemic bowel disease).
  • uncontrolled high blood pressure.

Taken Any Of The Following Medicines In The Last 24 Hours: 

  • almotriptan (AXERT)
  • eletriptan (RELPAX)
  • naratriptan (AMERGE)
  • rizatriptan (MAXALT, MAXALT-MLT)
  • sumatriptan (IMITREX, IMITREX STATDOSE, ONZETRAXSAIL, ZEMBRACESYMTOUCH)
  • sumatriptan and naproxen (TREXIMET)
  • zolmitriptan (ZOMIG, ZOMIG-ZMT)
  • ergotamine or ergotamine-type medicines (CAFERGOT, ERGOMAR, D.H.E.45, MIGRANAL, MIGERGOT)

Ask your healthcare provider if you are not sure if your medicine is listed above.

  • an allergy to frovatriptan or any of the ingredients in frovatriptan succinate tablets.

Before Taking Frovatriptan Succinate Tablets, Tell Your Doctor About All Of Your Medical Conditions, Including If You: 

  • have high blood pressure.
  • have high cholesterol.
  • have diabetes.
  • have liver problems.
  • smoke.
  • are overweight.
  • have heart disease or a family history of heart disease or stroke.
  • have any allergies.
  • are pregnant or plan to become pregnant. It is not known if frovatriptan succinate tablets can harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if frovatriptan succinate passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take frovatriptan succinate tablets.

Tell your doctor about all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Frovatriptan succinate tablets and certain other medicines can affect each other, causing serious side effects.

E

Specially Tell Your Doctor If You Take: 

  • ergotamine or triptan medicine
  • opioid pain medicine

Antidepressant Medicines Called: 

  • selective serotonin reuptake inhibitors (SSRIs)
  • serotonin norepinephrine reuptake inhibitors (SNRIs)
  • tricyclic antidepressants (TCAs)
  • monoamine oxidase inhibitors (MAOIs)

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 takefrovatriptansuccinatetablets?

  • Certain people should take their first dose of frovatriptan succinate tablet in their doctor s office or in another medical setting. Ask your doctor if you should take your first dose in a medical setting.
  • Take frovatriptan succinate tablets exactly as your doctor tells you.
  • Take frovatriptan succinate tablets by mouth with fluids.
  • If you do not get any relief from your headache after your first frovatriptan succinate 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 may take a second frovatriptan succinate tablet if it has been at least 2 hours after the first tablet.
  • Do not take more than 3 frovatriptan succinate tablets in a 24-hour period.
  • It is not known if it is safe to take frovatriptan succinate tablets for more than 4 headaches in 30 days.
  • If you take too much frovatriptan succinate 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 frovatriptan succinate tablets so you can talk with your doctor about how frovatriptan succinate tablets are working for you.

What should I avoid while takingfrovatriptansuccinatetablets?

Frovatriptan succinate 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 offrovatriptansuccinatetablets?

Frovatriptansuccinatetabletscan cause serious side effects.

  • Stroke.Stop taking frovatriptan succinate tablets and get emergency medical help right away if you have any of the following symptoms of a stroke:
  • face drooping
  • slurred speech
  • unusual weakness or numbness
  • Changes in color or sensation in your fingers and toes (Raynaud s syndrome).
  • Stomach and intestinal problems(gastrointestinal and colonic ischemic events). Symptoms of gastrointestinal and colonic ischemic events include:
  • sudden or severe stomach pain
  • stomach pain after meals
  • weight loss
  • nausea or vomiting
  • constipation or diarrhea
  • bloody diarrhea
  • fever
  • Problems with blood circulation to your legs and feet(peripheral vascular ischemia). Symptoms of peripheral vascular ischemia include:
  • cramping and pain in your legs or hips
  • feeling of heaviness or tightness in your leg muscles
  • burning or aching pain in your feet or toes while resting
  • numbness, tingling, or weakness in your legs
  • cold feeling or color changes in one or both legs or feet
  • Medication overuse headache.Some people who use too many frovatriptan succinate tablets may have worse headaches (medication overuse headache). If your headaches get worse, your doctor may decide to stop your treatment with frovatriptan succinate tablets.
  • Serotonin syndrome.Serotonin syndrome is a rare but serious problem that can happen in people using frovatriptan succinate tablets, especially if frovatriptan succinate tablets are used with anti-depressant medicines called SSRIs, SNRIs, TCAs, and MAOIs. Call your doctor right away if you have any of the following symptoms of serotonin syndrome:
  • mental changes such as

    • Store frovatriptan succinate tablets at 20 to 25 C (68 to 77 F); excursions permitted between 15 to 30 C (59 to 86 F).
    • Protect frovatriptan succinate tablets from moisture.
    • Throw away (discard) after expiration date printed on the carton.

    Keepfrovatriptansuccinatetabletsand all medicines out of the reach of children.

    General information about the safe and effective use offrovatriptansuccinatetablets.

    Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use frovatriptan succinate tablets for a condition for which it was not prescribed. Do not give frovatriptan succinate tablets to other people, even if they have the same symptoms that you have. It may harm them.

    You can ask your doctor or pharmacist for information about frovatriptan succinate tablets that is written for health professionals.

    What are the Ingredients infrovatriptansuccinatetablets?

    Active Ingredient: frovatriptan succinate

    Inactive Ingredients: anhydrous lactose, hypromellose, lactose monohydrate, polyethylene glycol, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium starch glycolate, titanium dioxide and triacetin.

    For more information, go to www.amneal.com or call 1-877-835-5472.

    All trademarks are the property of their respective owners.

    This Patient Information has been approved by the U.S. Food and Drug Administration.

    Manufactured by:
    Amneal Pharmaceuticals Pvt. Ltd.
    Oral Solid Dosage Unit

    Ahmedabad 382213, INDIA

    Distributed by:
    Amneal Pharmaceuticals LLC
    Bridgewater, NJ 08807

    Rev. 01-2019-01

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Patient Information).

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

Inform patients that frovatriptan succinate 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)].

HypersensitivityReactions

Inform patients that anaphylactic reactions have occurred in patients receiving frovatriptan succinate. Inform patients that such reactions can be life threatening or fatal and to seek immediate medical attention if they have anaphylactic symptoms. 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 frovatriptan succinate or other triptans, particularly during combined use with SSRIs, SNRIs, TCAs, and MAO inhibitors[seeWarnings and Precautions (5.7)andDrug Interactions (7.3)].

Pregnancy

Advise patients to notify their healthcare provider if they become pregnant during treatment or plan to become pregnant[seeUse in Specific Populations (8.1)].

Lactation

Inform patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed[see Use in SpecificPopulations (8.2)].

Manufactured by:
Amneal Pharmaceuticals Pvt. Ltd.
Oral Solid Dosage Unit

Ahmedabad 382213, INDIA

Distributed by:
Amneal Pharmaceuticals LLC

Bridgewater, NJ 08807



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