FROVA (FRO-va) (frovatriptan succinate) Tablets
FROVA (FRO-va) (frovatriptan succinate) Tablets
Read this Patient Information before you start taking FROVA and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor. You and your doctor should discuss FROVA when you start taking your medication and at regular check-ups.
What is FROVA?
FROVA is a prescription medicine used to treat migraine headaches with or without aura in adults.
FROVA is not used to treat other types of headaches.
FROVA is not used to prevent or decrease the number of migraine headaches.
It is not known if FROVA is safe and effective to treat cluster headaches.
It is not known if FROVA is safe and effective in children under 18 years of age.
Who should not take FROVA? Do not take FROVA if 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
hemiplegic migraines or basilar migraines. If you are not sure if you have these types of migraines, ask your healthcare provider.
narrowing of blood vessels to your legs, arms, or stomach (peripheral vascular disease)
uncontrolled high blood pressure
taken any of the following medicines in the last 24 hours:
o almotriptan (AXERT®)
o eletriptan (RELPAX®)
o naratriptan (AMERGE®)
o rizatriptan (MAXALT®, MAXALT-MLT®)
o sumatriptan (IMITREX®, SUMAVEL® DosePro®, ALSUMA®)
o sumatriptan and naproxen (TREXIMET®)
o zolmitriptan (ZOMIG®)
o Ergotamine or ergotamine-type medicines (BELLERGAL®, CAFERGOT® , ERGOMAR®, WIGRAINE®, D.H.E.45®, MIGRANAL®, SANSERT®) 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 FROVA. See the end of this leaflet for a complete list of ingredients in FROVA.
What should I tell my doctor before taking FROVA?
Before you take FROVA, tell your doctor about all of your medical conditions, including if you:
have high blood pressure
have high cholesterol
are a female who has gone through menopause
have heart disease or a family history of heart disease or stroke
are breastfeeding or plan to breastfeed
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
Especially tell your doctor if you take:
selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), two types of drugs for depression or other disorders. Common SSRIs are CELEXA® (citalopram HBr), LEXAPRO® (escitalopram oxalate), PAXIL® (paroxetine), PROZAC®/SARAFEM® (fluoxetine), SYMBAX® (olanzapine/fluoxetine), ZOLOFT® (sertraline), and fluvoxamine. Common SNRIs are CYMBALTA® (duloxetine) and EFFEXOR® (venlafaxine).
These medicines may affect how FROVA works, or FROVA may affect how these medicines work.
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 FROVA?
Certain people should take their first dose of FROVA 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 FROVA exactly as your doctor tells you.
If you do not get any relief after your first FROVA 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 FROVA tablet 2 hours after the first tablet.
Do not take more than 3 FROVA tablets in a 24-hour period.
It is not known if it is safe and effective to take FROVA for more than 4 headaches in 30 days.
If you take too much FROVA, 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 FROVA so you can talk with your doctor about how FROVA is working for you.
What should I avoid while taking FROVA?
FROVA 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 FROVA? FROVA can cause serious side effects.
Call your doctor right away if you have any of the following symptoms after taking FROVA:
Heart attack or other heart problems. Heart problems may lead to death. Stop taking FROVA and get emergency medical help right away if you have any of the following symptoms of a heart attack or other heart problems:
o Discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
o Chest pain or chest discomfort that feels like heavy pressure, squeezing, or fullness
o Pain or discomfort in your arms, back, neck, jaw, or stomach
o Shortness of breath with or without chest discomfort
o Breaking out in a cold sweat
o Feeling lightheaded
o Nausea or vomiting with any of the symptoms included above
Stroke. Symptoms of stroke include face drooping, slurred speech, and 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:
o Sudden or severe stomach pain
o Stomach pain after meals
o Weight loss
o Nausea or vomiting
o Constipation or diarrhea
o Bloody diarrhea
Problems with blood circulation to your legs and feet (peripheral vacular ischemia). Symptoms of peripheral vascular ischemia include:
o Cramping and pain in your legs or hips
o Feeling of heaviness or tightness in your leg muscles
o Burning or aching pain in your feet or toes while resting
o Numbness, tingling, or weakness in your legs
o Cold feeling or color changes in one or both legs or feet
Allergic reactions. Symptoms of allergic reaction include:
o Swelling of the face, mouth, throat, or tongue
o Difficulty breathing
Medication overuse headache. Some people who use too many FROVA tablets may have worse headaches (medication overuse headache). If your headaches get worse, your doctor may decide to stop your treatment with FROVA.
Serotonin syndrome. Serotonin syndrome is a rare but serious problem that can happen in people using FROVA, especially if FROVA is used with anti-depressant medicines called SSRIs and SNRIs. Call your doctor right away if you have any of the following symptoms of serotonin syndrome:
o Mental changes such as seeing things that are not there (hallucinations), agitation, or coma
o Fast heartbeat
o Changes in blood pressure
o High body temperature
o Tight muscles
o Trouble walking
The most common side effects of FROVA are:
headache (other than a migraine headache)
paresthesia (feeling of tingling)
flushing (hot flashes)
feeling hot or cold
skeletal pain (pain in joints or bones)
Tell your doctor about any symptoms that you develop while taking FROVA.
This is not a complete list of side effects. Talk to your doctor if you develop any symptoms that concern you.
How should I store FROVA?
Store FROVA at between 59°F to 86°F (15°C to 30°C). Protect FROVA from moisture. Discard after expiration date printed on package.
Keep FROVA and all medicines out of the reach of children.
General advice about the safe and effective use of FROVA.
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use FROVA for a condition for which it was not prescribed. Do not give FROVA to other people, even if they have the same symptoms as you. People may be harmed if they take medicines that have not been prescribed for them.
This leaflet summarizes the most important information about FROVA. If you would like more information about FROVA, talk to your doctor. You can ask your doctor or pharmacist for information on FROVA that is written for healthcare professionals. You can also call 1-800-4623636 or visit our website at www.FROVA.com.
What are the Ingredients in FROVA?
Active ingredient: frovatriptan succinate Inactive ingredients: lactose NF, microcrystalline cellulose NF, colloidal silicon dioxide NF, sodium starch glycolate NF, magnesium stearate NF, hypromellose USP, polyethylene glycol 3000 USP, triacetin USP, and titanium dioxide USP
Manufactured for: Endo Pharmaceuticals Inc., Malvern, PA 19355 Manufactured by: Almac Pharma Services Limited, Craigavon, BT63 5UA, UK
FROVA is a registered trademark of Vernalis Development Limited.
© 2013 Endo Pharmaceuticals Inc. All rights reserved.
U.S. Patent Nos 5,962,501, 5,827,871, 5,637,611 and 5,464,864 and 5,616,603 .
Reference ID: 3389176 15
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