Patient prescribing information

PATIENT INFORMATION ABOUT
FROVA® (frovatriptan succinate) Tablets Read this information before you start taking FROVA (FRO-va). (olanzapine/fluoxetine), ZOLOFT® (sertraline), and fluvoxamine. Also, read the information each time you renew your prescription, Common SNRIs are CYMBALTA® (duloxetine) and EFFEXOR® 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 These medicines may affect how FROVA works, or FROVA may FROVA before you start taking the medicine and at regular How should you take FROVA?
What is FROVA?
Take one FROVA tablet anytime after the start of your migraine FROVA is a prescription medicine used to treat migraine attacks in headache. If your headache comes back after your first dose, you adults. It is in the class of drugs called selective serotonin may take a second tablet after two (2) hours. Do not take more than three (3) FROVA tablets in a 24-hour period. FROVA should only be taken for a migraine headache. Do not use If you take too much medicine, contact your doctor, hospital FROVA to treat headaches that might be caused by other emergency department, or poison control center right away. conditions. Tell your doctor about your symptoms. Your doctor will decide if you have migraine headaches and if FROVA is for you. What are the common side effects of FROVA?
There is more information about migraine at the end of this The most common side effects associated with use of FROVA are: Who should not take FROVA?
• headache (other than a migraine headache) • 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 • skeletal pain (pain in joints or bones) • have circulation (blood flow) problems • have taken a similar drug (a serotonin receptor agonist) in the Tell your doctor about any symptoms that you develop while last 24 hours. These include sumatriptan (IMITREX®), taking FROVA. If you feel dizziness or fatigue, take extra care or naratriptan (AMERGE™), zolmitriptan (ZOMIG™), rizatriptan (MAXALT™), eletriptan hydrobromide (RELPAX®), or almotriptan In very rare cases, patients taking this class of medicines • have taken ergotamine type medicines in the last 24 hours. experience serious heart problems, stroke, or increased blood These include BELLERGAL®, CAFERGOT®, ERGOMAR®, pressure. If you develop pain, tightness, heaviness, or pressure in your chest, throat, neck, or jaw, contact your doctor right away. • have any allergic reaction to the tablet Also contact your doctor right away if you develop a rash or What you should tell your doctor before and during
itching after taking FROVA. You may be allergic to this medicine. treatment with FROVA?
What is a migraine and how does it differ from other
To help your doctor decide if FROVA is right for you, tell your headaches?
• are pregnant, or planning to become pregnant Migraine is an intense, throbbing headache that often affects one • are breast-feeding or plan to breast-feed side of the head. It often includes nausea, vomiting, and • have any history of chest pain, shortness of breath, or sensitivity to light and sound. The pain and symptoms from a migraine headache may be worse than the pain and symptoms of • have any risk factors for heart disease, including a common headache. Migraine headaches usually last for hours or Some people have problems with vision (an aura) before they get a migraine headache. These include flashing lights, wavy lines, Only your doctor can determine that your headache is a migraine headache, so it is important that you discuss all of your symptoms • are taking any other medicines, including prescription and non- prescription medicines, and herbal supplements • have any past or present medical problems LEXAPRO® / CELEXA® are registered trademarks of Forest • have previous allergies to any medicine PAXIL® is a registered trademark of GlaxoSmithKline. PROZAC® / SARAFEM® / SYMBYAX® / CYMBALTA® are registered • selective serotonin reuptake inhibitors (SSRIs) or serotonin ZOLOFT® is a registered trademark of Pfizer Pharmaceuticals. norepinephrine reuptake inhibitors (SNRIs), two types of drugs EFFEXO R® is a registered trademark of Wyeth Pharmaceuticals. for depression or other disorders. Common SSRIs are CELEXA® FROVA is a registered trademark of Vernalis Development Limited.
(citalopram HBr), LEXAPRO® (escitalopram oxalate), PAXIL® (paroxetine), PROZAC®/SARAFEM® (fluoxetine), SYMBYAX®

Source: http://www.accurateclinic.com/docs/Accurate-educ_Frova_Patient_Info.pdf

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Material safety data sheet

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