When This Medicine Should Not Be Used:
Do not use this medicine if you have had an allergic reaction to zolmitriptan or if you have heart disease, blood vessel disease, or circulation problems. Do not use this medicine if you have high blood pressure that is not under control or a history of heart disease, heart attack, angina, heart rhythm problem, stroke, transient ischemic attack (TIA), or ischemic bowel disease. Do not use this medicine for hemiplegic or basilar migraine headaches. Do not use this medicine if you have used an MAO inhibitor (MAOI) such as phenelzine, tranylcypromine, Nardil®, or Parnate® within the past 14 days. Do not use this medicine if you have taken another migraine headache medicine in the past 24 hours, such as another triptan or an ergot medicine. These medicines include almotriptan (Axert™), dihydroergotamine (D.H.E. 45®, Migranal®), eletriptan (Relpax®), ergotamine (Cafergot®, Ergomar®, Wigraine®), frovatriptan (Frova®), rizatriptan (Maxalt®), or sumatriptan (Imitrex®, Treximet®).

How to Use This Medicine:
Tablet, Dissolving Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Keep the orally disintegrating tablet in the blister pack inside the outer foil pouch until you are ready to take the medicine. Make sure your hands are dry and peel open the blister to remove the tablet. Do not break the tablet. Place the tablet on your tongue and let it dissolve. You do not need to drink water to swallow the dissolved tablet.
• If your headache does not get any better after 1 dose of medicine, you may use 1 additional dose of zolmitriptan if at least 2 hours have passed after the first dose. Do not use more than 2 doses in any 24-hour period.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you use cimetidine (Tagamet®) or a medicine for depression (such as amitriptyline, citalopram, fluoxetine, nortriptyline, sertraline, Cymbalta®, Effexor®, Elavil®, Lexapro®, Pristiq®).

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding or if you have kidney disease, liver disease, high blood pressure, or a family history of heart disease. Tell your doctor if you have a history of stomach or bowel bleeding, Raynaud disease, or other blood flow problems.
• This medicine should be used only for classic or common migraine headaches. It should not be used to treat any other kind of headache or pain.
• This medicine can cause heart problems, including heart attack. This is more likely to happen if you already have heart disease. Tell your doctor if you have any risk factors for heart disease, such as high blood pressure, smoking, diabetes, or a family history of heart disease or stroke.
• Check with your doctor right away if you have chest discomfort, jaw or neck tightness after you take this medicine. Also tell your doctor if you have sudden or severe stomach pain or bloody diarrhea after you use this medicine. Tell your doctor if you have any changes in vision that are not part of your usual migraine.
• Your headaches may become worse if you use zolmitriptan alone or in combination with other migraine medicines for 10 or more days per month. Keep a headache diary to record your headache frequency and drug use.
• This medicine may cause a serious condition called serotonin syndrome when taken with certain medicines. Call your doctor right away if you have a fever, confusion, mental changes, restlessness, fast heartbeat, muscle spasms, trouble walking, nausea, vomiting, or diarrhea.
• This medicine may make you dizzy. Do not drive, use machines, or do anything else that could be dangerous until you know how this medicine affects you.
• The orally disintegrating tablet contains phenylalanine. Tell your doctor if you have phenylketonuria (PKU) before you use this form of zolmitriptan.
• Call your doctor if your symptoms do not improve or if they get worse.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, especially if it spreads to your arms, jaw, back, or neck
• Fast or uneven heartbeat
• Fever, confusion, mental changes, restlessness, muscle spasms, trouble walking
• Numbness or tingling in your hands, arms, legs, or feet
• Severe stomach pain, bloody diarrhea, vomiting, nausea, fever
• Sudden severe headache (other than the one being treated)
• Tightness or discomfort in your chest, neck, or jaw
• Vision changes that are not part of a usual migraine

If you notice these less serious side effects, talk with your doctor:

• Feeling dizzy, drowsy, weak, or tired

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088