Important Safety Information
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Do not use ZOMIG if you have:
- heart problems, a history of heart problems or heart attacks, 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)
- moderate or severe liver problems (hepatic impairment)
- 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 or ZOMIG Tablets
If you are not sure about any of the above, ask your healthcare provider.
Before taking ZOMIG, tell your healthcare provider:
- about all your medical conditions, including 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 healthcare provider about the best way to feed your baby while using ZOMIG.
- about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
- 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 can cause serious side effects such as heart attacks (symptoms may 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 may 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 may include stomach pain, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever, changes in color or sensation in your fingers and toes, pain, weakness, cold feeling, numbness, tingling, or color change in legs or feet), 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 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 may have a reaction called serotonin syndrome which can be life-threatening. In particular this reaction may occur when ZOMIG 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
- If you are sensitive to phenylalanine (which can be found in aspartame). Phenylalanine can be harmful to patients with phenylketonuria. ZOMIG orally disintegrating tablets contain phenylalanine.
- The most common side effects reported by adult patients in clinical studies for ZOMIG Nasal Spray include unusual taste, numbness, dizziness, and skin sensitivity
- The most common side effect in pediatric patients (12 to 17 years of age) in clinical trials for ZOMIG Nasal Spray was unusual taste
- The most common side effects in adult patients in clinical studies for ZOMIG Tablets were neck/throat/jaw pain/tightness/pressure, dizziness, tingling, tiredness, drowsiness, feeling warm/cold, nausea, heaviness sensation, and dry mouth
These are not all of the possible side effects of ZOMIG. For more information, ask your healthcare provider.
Approved Use for ZOMIG
ZOMIG is a prescription medicine available in a nasal spray, tablet, and orally disintegrating tablet. ZOMIG Nasal Spray is used to treat migraine headaches with or without aura in adults and pediatric patients (12 to 17 years of age). ZOMIG tablets and orally disintegrating tablets are used to treat migraine headaches with or without aura in adults.
Limitations of Use:
ZOMIG 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, then your healthcare provider will need to determine if you really have a migraine headache before you take another dose. ZOMIG is not for the prevention of migraines. ZOMIG is not for other types of headaches, including cluster headache. It is not known if ZOMIG Nasal Spray is safe and effective in children under 12 years of age or patients over 65 years of age. Only your healthcare provider can determine if ZOMIG is right for you.
The maximum daily dose is 10 mg of ZOMIG in any 24-hour period. It is not known if it is safe and effective to use ZOMIG Nasal Spray for more than 4 headaches in 30 days. It is not known if taking more than 1 dose of ZOMIG Nasal Spray in 24 hours is safe and effective in pediatric patients 12 to 17 years of age.
Please see full Prescribing Information and Patient Information for ZOMIG Nasal Spray or ZOMIG Tablets, and discuss with your healthcare provider.
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.