Important Safety Information
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 (TIAs), or problems with your blood circulation
• hemiplegic migraines or basilar migraines. If you are not sure if you have these types of migraines, ask your healthcare provider
• narrowing of blood vessels to your legs, arms, or stomach (peripheral vascular disease)
• uncontrolled high blood pressure
• used other migraine medications in the last 24 hours, including other triptans, ergots, or ergot-type medications
• used monoamine oxidase A inhibitors (MAO-A inhibitors) or you stopped taking a MAO-A inhibitor in the last 14 days
• allergies to zolmitriptan or any of the ingredients in ZOMIG Nasal Spray
If you are not sure about any of the above, ask your doctor.
• Before taking ZOMIG Nasal Spray, tell your doctor about all your medical conditions, including if you have high blood pressure, high cholesterol, diabetes, if you 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, are breastfeeding or plan to breastfeed. Talk to your doctor about the best way to feed your baby while using ZOMIG Nasal Spray.
• 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 (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase (MAO) inhibitors or cimetidine (reduces stomach acid production)
• ZOMIG Nasal Spray can cause serious side effects such as heart attacks (symptoms include severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw that is severe or does not go away), increases in blood pressure, stroke (symptoms include slurring of speech; or unusual weakness or numbness), life-threatening disturbances of heart rhythm, constriction of blood vessels in the abdomen or other parts of the body (symptoms include changes in color or sensation in your fingers and toes), or serious allergic reactions (symptoms include hives; tongue, mouth, lip or throat swelling; problems breathing). In extremely rare cases, patients have died from these side effects. If you experience any of the above side effects, seek emergency help or contact your doctor right away
• ZOMIG Nasal Spray can cause dizziness, weakness, or drowsiness. If you have any of these symptoms do not drive a car, use machinery, or do anything that needs you to be alert
• Some people who take ZOMIG Nasal Spray may have a reaction called serotonin syndrome which can be life- threatening. In particular this reaction may occur when ZOMIG Nasal Spray is used together with certain types of antidepressants known as SSRIs or SNRIs. Symptoms may include mental changes (confusion, seeing things that are not there (hallucinations), agitation, coma), fast heartbeat, changes in blood pressure, feeling faint, fever, sweating, muscle spasm, trouble walking, nausea, vomiting, and/or diarrhea. Call your doctor immediately if you have any of these symptoms after taking ZOMIG Nasal Spray
• The safety and effectiveness of ZOMIG Nasal Spray have not been established in patients under 12 years of age or patients over 65 years of age
• The most common side effects reported by adult patients in clinical studies for ZOMIG Nasal Spray include unusual taste; tingling sensation; skin sensitivity; dizziness; nausea; pain, warm sensation, pressure, and tightness sensations such as in the nose, throat, or chest; drowsiness; weakness; disorder/discomfort of the nasal cavity; and dry mouth
• The most common side effects in pediatrics (12 to 17 years of age) in clinical trials for ZOMIG Nasal Spray were unusual taste, nasal discomfort, dizziness, mouth/throat pain and nausea
These are not all of the possible side effects of ZOMIG Nasal Spray. For more information, ask your doctor
Approved Use for 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). It is not known if ZOMIG Nasal Spray is safe and effective in children under 12 years of age. Only your doctor can determine if ZOMIG Nasal Spray is right for you.
Limitations of Use:
ZOMIG Nasal Spray should only be used where a clear diagnosis of migraine has been established. For a given migraine attack, if you do not respond to the first dose of ZOMIG Nasal Spray, then your doctor will need to determine if you really have a migraine headache before you take another dose. ZOMIG Nasal Spray is not for the prevention of migraines. ZOMIG Nasal Spray is not for other types of headaches, including cluster headache. ZOMIG Nasal Spray is not for people with moderate or severe liver problems (hepatic impairment).
The maximum daily dose should not exceed 10 mg in any 24-hour period.
To report SUSPECTED ADVERSE REACTIONS, contact Amneal Specialty, a division of Amneal Pharmaceuticals LLC at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.