Zolmitriptan 2.5mg Tablet - 6 Tablet Box

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

ZOLMITRIPTAN - ORAL

(zol-meh-TRIP-tan)

COMMON BRAND NAME(S): Zomig

USES: Zolmitriptan is used to treat migraines. It helps to relieve headaches, pain, and other symptoms of migraines, including nausea, vomiting, and sensitivity to light/sound. Prompt treatment allows you to get back to your normal routine and may decrease your need for other pain medications. Zolmitriptan does not prevent future migraines or reduce how often you may get a migraine. Zolmitriptan belongs to a group of drugs called "triptans." Migraines are thought to occur when certain blood vessels in the brain become swollen (dilated). This drug works by helping blood vessels in the brain to return to normal size. It may also block pain signals in the brain.

HOW TO USE: Read the Patient Information Leaflet available from your pharmacist before you start using zolmitriptan and each time you get a refill. Ask your doctor or pharmacist if you have any questions. Your dosage is based on your medical condition and response to treatment. Take this medication by mouth, with or without food, at the first sign of a migraine as directed by your doctor. 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, or if your headache comes back, you may take a second dose after 2 hours or as directed by your doctor. Do not take more than 10 milligrams in a 24-hour period. If you have certain conditions that increase your risk of heart disease and you have never taken this medication before, you may need to be monitored for rare but serious side effects (e.g., chest pain) when you take the first dose. Your doctor may ask you to take the first dose in the office. See Precautions section for more information. 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: Tingling/numbness, nausea, dry mouth, 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 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. Tell your doctor immediately if any of these unlikely but serious side effects occur: blue fingers/toes/nails, cold feeling in the hands/feet. Pain/pressure/tightness in the chest/neck/jaw can occur shortly after using zolmitriptan. These side effects are usually not serious. However, you may not be able to tell them apart from a rare but very serious reaction related to a lack of blood flow to the heart, brain, or other parts of the body. Therefore, seek immediate medical attention if you notice any of these unlikely side effects: chest/jaw/left arm pain, fainting, irregular/pounding heartbeat, vision changes, severe nausea, weakness on one side of the body, confusion, seizures, slurred speech, sudden or severe stomach/abdominal pain, trouble swallowing, bloody diarrhea. This medication may rarely cause a very serious condition called serotonin syndrome. The risk increases when this medication is used with certain other drugs such as other "triptans" used to treat migraine headaches (e.g., sumatriptan, eletriptan), 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. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: 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.

PRECAUTIONS: See also How to Use section. Before taking zolmitriptan, tell your doctor or pharmacist if you are allergic to it; or to other "triptan" migraine drugs; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: heart disease (e.g., chest pain, heart attack, irregular heartbeat, coronary artery disease, vasospasm), blood flow problems in the brain (e.g., stroke, transient ischemic attack), blood vessel disease (e.g., peripheral vascular disease, ischemic bowel disease), uncontrolled high blood pressure (hypertension), certain types of headaches (hemiplegic or basilar migraine), severe liver disease. Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood circulation disorder (e.g., Raynaud's disease), kidney disease. Before using this medication, tell your doctor or pharmacist if you have any condition that increases your risk of heart disease, including: high cholesterol level, high blood pressure, diabetes, smoking history, family history of heart disease or stroke, overweight, female after menopause, male older than 40 years. If you are at high risk for heart disease, your doctor may want to check your heart before prescribing zolmitriptan. This drug 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. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: See also Side Effects section. Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first. This drug should not be used with the following medications because very serious interactions may occur: sibutramine. Do not take MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) within 2 weeks before, during, and after treatment with this medication. In some cases a serious (possibly fatal) drug interaction may occur. This drug should not be used within 24 hours of the following medication because very serious interactions may occur: ergot-type drugs (e.g., ergotamine, dihydroergotamine, methysergide), other "triptan" migraine drugs (e.g., sumatriptan). If you are currently using any of the above medications, tell your doctor or pharmacist before starting zolmitriptan. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription products you may use, especially of: hormonal birth control (pill, patch, ring), cimetidine, certain types of antidepressants (e.g., SSRIs such as fluoxetine/paroxetine/sertraline, NSRIs such as venlafaxine), St John's wort. Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone). Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely. Cimetidine is a nonprescription drug that is commonly used to treat extra stomach acid. Because it may interact with zolmitriptan, ask your pharmacist about other products to treat stomach acid. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others. Laboratory and/or medical tests (e.g., EKG) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: Not applicable.

STORAGE: Store the US product at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Store the Canadian product at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised January 2012. Copyright(c) 2012 First Databank, Inc.