Patient Information

Frovatriptan Succinate (froe” va trip’ tan sux’ i nate) Tablets

What is the most important information I should know about frovatriptan succinate tablets ?

Frovatriptan 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 cholesterol levels
are overweight
have a family history of heart disease

W hat are frovatriptan succinate 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.

W ho should not take frovatriptan succinate tablets ?

Do not take frovatriptan succinate tablets i 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, ONZETRA™ XSAIL™, ZEMBRACE™ SYMTOUCH™)
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. See the end of this leaflet for a complete list of ingredients in frovatriptan succinate tablets.

W hat should I tell my doctor before taking 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.

T ell 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.

H ow should I take frovatriptan succinate tablets ?

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.

W hat should I avoid while taking frovatriptan succinate tablets ?

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.

W hat are the possible side effects of frovatriptan succinate tablets ?

Frovatriptan succinate tablets c a n cause serious side effects.

See “What is the most important information I should know about frovatriptan succinate tablets?”

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

M edication 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 seeing things that are not there (hallucinations), agitation, or coma
fast heartbeat
changes in blood pressure

high body temperature
tight muscles
trouble walking

I ncreased blood pressure.

A l l ergic reactions. Call your doctor or get emergency medical help right away if you have symptoms of an allergic reaction, including:

rash
hives
itching

swelling of the face, mouth, throat, or tongue
difficulty breathing

The most common side effects of frovatriptan succinate tablets are:

dizziness
fatigue (tiredness, drowsiness)
headache (other than a migraine headache)
tingling or numbness in your fingers or toes
warm, hot, burning feeling of your face (flushing)

dry mouth
feeling hot or cold
pain in joints or bones
chest pain
indigestion

These are not all the possible side effects of frovatriptan succinate 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.

H ow should I store frovatriptan succinate tablets ?

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.

Keep frovatriptan succinate tablets a nd all medicines out of the reach of children.

G eneral information about the safe and effective use of frovatriptan succinate tablets .

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.

W hat are the Ingredients in frovatriptan succinate tablets ?

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

Packed by:
Amneal Pharmaceuticals Pvt. Ltd.
Ahmedabad 382220, INDIA

Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807

Rev. 09-2019-02

Frovatriptan