FROVATM (frovatriptan succinate) Tablets
Read this information before you start taking FROVA (FRO-va). Also, read the information each time you
renew your prescription, in case anything has changed. This leaflet does not contain all of the information about
FROVA. For further information or advice ask your doctor or pharmacist. You and your doctor should discuss FROVA
before you start taking the medicine and at regular checkups.
What is FROVA?
FROVA is a prescription medicine used to treat migraine attacks in adults. It is in the class of drugs
called selective serotonin receptor agonists. FROVA should only be taken for a migraine headache. Do not use FROVA to
treat headaches that might be caused by other conditions. Tell your doctor about your symptoms. Your doctor will
decide if you have migraine headaches and if FROVA is for you. There is more information about migraine at the end of
Who should not take FROVA?
Do not take FROVA if you:
* have uncontrolled high blood pressure
* have heart disease or a history of heart disease
* have hemiplegic or basilar migraine (if you are not sure about this, ask your doctor)
* have had a stroke
* have circulation (blood flow) problems
* have taken a similar drug (a serotonin receptor agonist) in the last 24 hours. These include
sumatriptan (IMITREX® ), naratriptan (AMERGE® ) zolmitriptan (ZOMIG® ),
rizatriptan (MAXALT® ), or almotriptan (AXERTTM)
* have taken ergotamine type medicines in the last 24 hours. These include BELLERGAL®,
CAFERGOT®, ERGOMAR®, WIGRAINE®, DHE 45®, or
* have any allergic reaction to the tablet
What should you tell your doctor before and during treatment with FROVA?
To help your doctor decide if FROVA is right for you, tell your doctor if you:
* are pregnant, or planning to become pregnant
* are breast-feeding or plan to breast-feed
* have any history of chest pain, shortness of breath, or palpitations
* have any risk factors for heart disease, including
- high blood pressure
- high cholesterol
- a family history of heart disease
- past menopause
- male over 40 years old
- are taking any other medicine, including prescription and nonprescription medicines, and herbal supplements
* have any past or present medical problems
* have previous allergies to any medicine Tell your doctor if you take
* selective serotonin reuptake inhibitors (SSRIs) such as Prozac® (fluoxetine), Luvox® (fluvoxamine),
Paxil® (paroxetine), and Zoloft® (sertraline) These medicines may affect how FROVA works, or FROVA may affect
how these medicines work.
How should you take FROVA?
* Take one FROVA tablet anytime after the start of your migraine headache.
* If your headache comes back after your first dose, you may take a second tablet after two (2)
hours. Do not take more than three (3) FROVA tablets in a 24-hour period.
* If you take too much medicine, contact your doctor, hospital emergency department, or poison
control center right away.
What are the common side effects of FROVA?
The most common side effects associated with use of FROVA are:
* fatigue (tiredness)
* headache (other than a migraine headache)
* paresthesia (feeling of tingling)
* dry mouth
* flushing (hot flashes)
* feeling hot or cold
* chest pain
* dyspepsia (indigestion)
* skeletal pain (pain in joints or bones)
Tell your doctor about any symptoms that you develop while taking FROVA. If you feel dizziness or
fatigue, take extra care or avoid driving and operating machinery.
In very rare cases, patients taking this class of medicines experience serious heart problems, stroke,
or increased blood pressure. If you develop pain, tightness, heaviness, or pressure in your chest, throat, neck, or
jaw, contact your doctor right away. Also contact your doctor right away if you develop a rash or itching after
taking FROVA. You may be allergic to this medicine.
What is a migraine and how does it differ from other headaches?
Migraine is an intense, throbbing headache that often affects one side of the head. It often includes
nausea, vomiting, and sensitivity to light and sound. The pain and symptoms from a migraine headache may be worse
than the pain and symptoms of a common headache. Migraine headaches usually last for hours or longer.
Some people have problems with vision (an aura) before they get a migraine headache. These include
flashing lights, wavy lines, and dark spots.
Only your doctor can determine that your headache is a migraine headache, so it is important that you
discuss all of your symptoms with your doctor.
Manufactured under license from Vernalis Limited., FROVA is a trademark of Vernalis Development
© 2002 Elan Pharmaceuticals, Inc.