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IMPORTANT INFORMATION FOR ZOMIG (zolmitriptan) Nasal Spray Only


What is ZOMIG Nasal Spray? ZOMIG Nasal Spray is a prescription medicine used to treat migraine headaches with or without aura in adults and pediatric patients (12 to 17 years of age). ZOMIG Nasal Spray is not for other headaches or the prevention of migraine headaches. ZOMIG Nasal Spray is not for people with moderate or severe liver problems. It is not known if ZOMIG Nasal Spray is safe and effective in children under 12 years of age.


Do not use ZOMIG Nasal Spray if you have:


 heart problems, a history of heart problems, or problems with the electrical system of your heart


 had a stroke, transient ischemic attacks, or problems with your blood circulation; hemiplegic or basilar migraines


 narrowing of blood vessels to your legs, arms, or stomach  uncontrolled high blood pressure


 used certain medicines called 5-HT1 agonists (“triptans”), medicines that contain ergotamine, or methysergide in the last 24 hours


 are taking a monoamine oxidase A inhibitor or you stopped taking a MAO-A inhibitor in the last 14 days


 are allergic to zolmitriptan or any of the ingredients in ZOMIG Nasal Spray, including zolmitriptan, citric acid, and disodium phosphate dodecahydrate.


What should I tell my doctor before using ZOMIG Nasal Spray? Before using ZOMIG Nasal Spray, tell your doctor about all of your medical conditions, including if you: Have high blood pressure; have high cholesterol; have diabetes; smoke; are overweight; are a female who has gone through menopause; have heart disease or a family history of heart disease or stroke; have liver problems; are pregnant or plan to become pregnant. (it is not known if ZOMIG Nasal Spray will harm your unborn baby); are breastfeeding or plan to breastfeed (it is not known if ZOMIG Nasal Spray passes into your breast milk. You and your doctor should decide if you will use ZOMIG Nasal Spray or breastfeed).


Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take: medicines used to treat mood disorders, including selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors or monoamine oxidase inhibitors; cimetidine.


What should I avoid while using ZOMIG Nasal Spray? ZOMIG Nasal Spray can cause dizziness, weakness, or drowsiness. If you have these symptoms do not drive a car, use machinery, or do anything that needs you to be alert.


ZOMIG Nasal Spray can cause serious side effects. Call your doctor right away if you have any of the following symptoms after using ZOMIG Nasal Spray:


 Heart attack and other heart problems. Heart problems may lead to death. Stop taking ZOMIG Nasal Spray and get emergency medical help right away if you have any of the following symptoms of a heart attack or other heart problems: discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back; chest pain or chest discomfort that feels like heavy pressure, squeezing, or fullness; pain or discomfort in your arms, back, neck, jaw, or stomach; shortness of breath with or without chest discomfort; breaking out in a cold sweat; feeling


lightheaded; nausea or vomiting with any of the symptoms included above.


 stroke. Symptoms of stroke include face drooping, slurred speech, and unusual weakness or numbness.


 changes in color or sensation in your fingers and toes (Raynaud’s syndrome)


 stomach and intestinal problems (gastrointestinal and colonic ischemic events). Symptoms of gastrointestinal and colonic ischemic events include: sudden or severe stomach pain; stomach pain after meals; weight loss; nausea or vomiting; constipation or diarrhea; bloody diarrhea; fever.


 problems with blood circulation to your legs and feet (peripheral vascular ischemia). Symptoms of peripheral vascular ischemia include: cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in 1 or both legs or feet


 serotonin syndrome. Serotonin syndrome is a serious and life- threatening problem that can happen in people using ZOMIG Nasal Spray, especially if ZOMIG Nasal Spray is used with anti- depressant medicines called selective serotonin reuptake inhibitors or selective norepinephrine reuptake inhibitors. Ask your doctor or pharmacist for a list of these medicines if you are not sure. Call your doctor right away if you have any of the following symptoms of serotonin syndrome: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; trouble walking; nausea, vomiting, or diarrhea


 increased blood pressure


 allergic reactions. Symptoms of an allergic reaction include: rash; hives; itching; swelling of the face, mouth throat, or tongue; difficulty breathing


The most common side effects of ZOMIG Nasal Spray are: unusual taste; numbness; dizziness; skin sensitivity (hyperparesthesia). These are not all the possible side effects of ZOMIG Nasal Spray. For more information ask your doctor or pharmacist.


Call your doctor for medical advice about side effects.


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA- 1088. To report SUSPECTED ADVERSE REACTIONS contact Impax Laboratories, Inc. at 1-877-994-6729.


Keep ZOMIG Nasal Spray out of the reach of children. Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use ZOMIG Nasal Spray for a condition for which it was not prescribed. Do not give ZOMIG Nasal Spray to other people, even if they have the same symptoms that you have. It may harm them. This summarizes the most important information about ZOMIG Nasal Spray. If you would like more information, talk to your doctor. You can ask your pharmacist or doctor for information about ZOMIG Nasal Spray that is written for health professionals. For more information go to www.ZOMIG.com or call 1-877-994-6729. ZOMIG is a registered trademark of the AstraZeneca group of companies.


©AstraZeneca 2013 Distributed by: Impax Specialty Pharma, a division of Impax Laboratories, Inc. Hayward, CA 94544


PP-XPI-ZNS-US-0011 3325613 Revised 11/2016


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