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Rizaliv General Information

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Rizaliv is used to treat migraines. It helps to relieve headache, pain, and other migraine symptoms (including nausea, vomiting, sensitivity to light/sound). Prompt treatment helps you return to your normal routine and may decrease your need for other pain medications. Rizaliv belongs to a class of drugs known as triptans. It affects a certain natural substance (serotonin) that causes narrowing of blood vessels in the brain. It may also relieve pain by affecting certain nerves in the brain.

Rizaliv does not prevent future migraines or lessen how often you get migraine attacks.

How to Use Rizaliv

Read the Patient Information Leaflet if available from your pharmacist before you start taking Rizaliv and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take Rizaliv by mouth as directed by your doctor, at the first sign of a migraine. It may be taken with or without food, but may work faster when it is taken on an empty stomach. The dosage is based on your medical condition, age, response to treatment, and other drugs you may be taking. For children, the dosage is also based on weight. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

If there is no improvement in your symptoms, do not take more doses of Rizaliv before talking to your doctor. If your symptoms are only partly relieved, or if your headache comes back, adults may take another dose at least 2 hours after the first dose. Children should not take more than one dose, or 5 milligrams in a 24-hour period. For adults, the US manufacturer recommends a maximum dose of 30 milligrams in a 24-hour period. The Canadian manufacturer recommends a maximum dose of 20 milligrams (for adults) in a 24-hour period.

If you have a higher risk for heart problems (see Precautions), your doctor may perform a heart exam before you start taking Rizaliv. He/she may also direct you to take your first dose of Rizaliv in the office/clinic to monitor for serious side effects (such as chest pain). Talk to your doctor for details.

Overuse of drugs to treat sudden migraine attacks can sometimes lead to worsening of headache (medication overuse headache) or rebound headache. Therefore, do not use Rizaliv more often or for longer than prescribed. Tell your doctor if you need to use Rizaliv 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 another medication to help prevent headaches.

Rizaliv Possible Side Effects

Flushing, feelings of tingling/numbness/prickling/heat, tiredness, weakness, drowsiness, or dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed Rizaliv because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using Rizaliv do not have serious side effects.

Rizaliv may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including: blue fingers/toes/nails, cold hands/feet, hearing changes, mental/mood changes.

Rizaliv can commonly cause chest/jaw/neck tightness, pain, or pressure that is usually not serious. However, these side effects are like symptoms of a heart attack, which may include chest/jaw/left arm pain, shortness of breath, or unusual sweating. Get medical help right away if these or other serious side effects occur, including: fast/irregular heartbeat, fainting, severe stomach/abdominal pain, bloody diarrhea, signs of a stroke (such as weakness on one side of the body, trouble speaking, sudden vision changes, confusion).

Rizaliv may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.

A very serious allergic reaction to Rizaliv is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Rizaliv Precautions

Before using Rizaliv, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. Rizaliv may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using Rizaliv, tell your doctor or pharmacist your medical history, especially of: blood circulation problems (for example, in your legs, arms/hands, or stomach), certain types of headaches (hemiplegic or basilar migraine), heart problems (such as chest pain, irregular heartbeat, previous heart attack), liver disease, seizure, stroke or "mini-stroke" (transient ischemic attack).

Certain conditions can increase your risk for heart problems. Tell your doctor if you have any of these conditions, including: high blood pressure, high cholesterol, diabetes, family history of heart disease, overweight, smoker, postmenopausal (women), age more than 40 years (men).

Rizaliv may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

The risk of heart disease, liver disease, and high blood pressure increases with age. Older adults may be more sensitive to the side effects of Rizaliv, especially increased blood pressure and heart problems.

During pregnancy, Rizaliv should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if Rizaliv passes into breast milk. Consult your doctor before breast-feeding.

Rizaliv Possible Intercations

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Taking MAO inhibitors with Rizaliv may cause a serious (possibly fatal) drug interaction. Do not take any MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) during treatment with Rizaliv. Most MAO inhibitors should also not be taken for two weeks before treatment with Rizaliv. Ask your doctor when to start or stop taking Rizaliv.

The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Examples include street drugs such as MDMA/"ecstasy," St. John's wort, certain antidepressants (including SSRIs such as fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine), among others. The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs.

If you also take any ergotamine medication (such as dihydroergotamine or methysergide) or other "triptan" drugs (such as sumatriptan, zolmitriptan), you will need to separate your Rizaliv dose at least 24 hours apart from your dose of these other medications to lessen the chance of serious side effects.

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