Disclaimer

frovatriptan - oral, Frova (cont.)

HOW TO USE: Read the Patient Information Leaflet available from your pharmacist before you start using frovatriptan and each time you get a refill. Ask your doctor or pharmacist if you have any questions.Take this medication by mouth at the first sign of a migraine, or as directed by your doctor. It may be taken with or without food, although faster relief may occur when it is taken on an empty stomach. Do not take frovatriptan to prevent a migraine. If there is no improvement in your symptoms, do not take any more doses of this medication before talking to your doctor.If your symptoms are only partly relieved, of if your headache comes back, the U.S. manufacturer recommends that you may take a second dose after 2 hours, but take no more than 7.5 milligrams (3 doses) in a 24-hour period. The Canadian manufacturer recommends that you may take a second dose after 4 hours, but take no more than 5 milligrams (2 doses) in a 24-hour period. Follow your doctor's direction carefully. If you have any questions, be sure to ask your doctor or pharmacist before you have to take this medication.If you have never taken this medication before and you have risk factors for heart disease (see Precautions), you may be advised to take your first dose in your doctor's office in order to monitor for rare but serious heart problems (e.g., heart attack).Your dosage is based on your medical condition and response to therapy. Tell your doctor if your condition does not improve or if it worsens.Overuse of drugs to treat sudden migraine attacks can lead to worsening of headache (medication overuse headache) or rebound headache. Therefore, do not use this medication more often or for longer than prescribed. Tell your doctor if you need to use this medication more often, if the medication is not working as well, or if you have more frequent or worse headaches. Your doctor may need to change your medication and/or add a separate medication to help prevent the headaches.

SIDE EFFECTS: Flushing, sensations of tingling/numbness/prickling/heat, weakness, stomach upset, dry mouth, drowsiness, or dizziness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Chest/jaw/neck tightness can commonly occur shortly after using frovatriptan. Only rarely are these signs of a serious condition. However, you may not be able to tell this apart from a serious reaction related to a lack of blood flow to the heart, brain or other parts of the body. Seek immediate medical attention if any of these unlikely but very serious (rarely fatal) side effects occur: chest pain, jaw/left arm pain, fainting, fast/irregular/pounding heartbeat, vision changes, weakness on one side of the body, confusion, slurred speech, sudden or severe stomach/abdominal pain, bloody diarrhea.Tell your doctor immediately if any of these unlikely but serious side effects occur: blue fingers/toes/nails, cold sensation of hands/feet, hearing changes, mental/mood changes.This medication may rarely cause a very serious condition called serotonin syndrome. The risk increases when this medication is taken with certain other drugs such as other "triptans" used to treat migraine headaches (e.g., sumatriptan, zolmitriptan), certain antidepressants including SSRIs (e.g., citalopram, fluoxetine, paroxetine) and NSRIs (e.g., duloxetine, venlafaxine), or a certain drug to treat obesity (sibutramine). Before taking this drug, tell your doctor if you take any of these medications. Serotonin syndrome may be more likely when you start or increase the dose of any of these medications. Seek immediate medical attention if you develop some of the following symptoms: hallucinations, unusual restlessness, loss of coordination, fast heartbeat, severe dizziness, high fever, severe nausea/vomiting/diarrhea, twitchy muscles.In the unlikely event you have a serious allergic reaction to this drug, seek immediate medical attention. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.



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