IMPORTANT SAFETY INFORMATION
Do not use ZOMIG 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 (MAO) inhibitors for depression or other conditions within
the last 14 days
- allergies to zolmitriptan or any of the ingredients in ZOMIG, ZOMIG-ZMT or ZOMIG
If you are not sure about any of the above, ask your doctor.
- Before taking ZOMIG, 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
- 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 can cause serious side effects. Seek emergency help right away if
you have any of the following symptoms of a heart attack such as: severe tightness,
pain, pressure, or heaviness in your chest, throat, neck, or jaw that is severe
or does not go away; shortness of breath or wheezing; or symptoms of a stroke such
as: slurring of speech; or unusual weakness or numbness. Call your doctor right
away if you have any of the following problems after taking ZOMIG: changes in color
or sensation in your fingers and toes; sudden or severe stomach pain; cramping or
pain in your legs or hips; bloody diarrhea; hives; tongue, mouth, lip or throat
swelling; problems seeing. ZOMIG can cause heart attacks, increases in
blood pressure, stroke, life-threatening disturbances of heart rhythm, constriction
of blood vessels in the abdomen or other parts of the body, or serious allergic
reactions. In extremely rare cases, patients have died from these side effects
- 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
- Tell your doctor if you are sensitive to phenylalanine, which can be found in the
artificial sweetener aspartame. ZOMIG-ZMT contains phenylalanine
- The safety and effectiveness of ZOMIG have not been established in patients under
18 years of age or patients over 65 years of age
- The most common side effects reported by patients in clinical trials for ZOMIG Tablets
and ZOMIG-ZMT Orally Disintegrating Tablets include tingling sensation; weakness;
nausea; dizziness; pain, tightness, pressure or heaviness such as in the chest,
throat, neck, or jaw; drowsiness; and warm sensation. The most common side effects
reported by patients in clinical studies for ZOMIG Nasal Spray include unusual taste;
tingling sensation; skin sensitivity; dizziness; nausea; pain, pressure, and tightness
sensations such as in the nose, throat, or chest; drowsiness; weakness; disorder/discomfort
of the nasal cavity; and dry mouth
Approved Use for ZOMIG
ZOMIG is a prescription medicine approved to treat migraine headaches in adults
with or without aura. It is not known if ZOMIG Nasal Spray is safe and effective
in children. Only your doctor can determine if ZOMIG is right for you.
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 doctor will need to determine if you really have a migraine headache before
you take another dose. ZOMIG is not for the prevention of migraines or for the treatment
of hemiplegic or basilar migraines (if you are not sure about this, ask your doctor).
ZOMIG 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).
Click here to see the full Prescribing Information for ZOMIG Nasal Spray
Click here to see the
full Prescribing Information for ZOMIG Tablets and ZOMIG-ZMT Orally Disintegrating
You are encouraged to report negative side effects of prescription drugs to the
FDA. Visit http://www.FDA.gov/medwatch
or call 1-800-FDA-1088.
The health information contained herein is provided for educational purposes only
and is not intended to replace discussions with a healthcare professional. All decisions
regarding patient care must be made with a healthcare professional, considering
the unique characteristics of the patient.
This Web site contains information relating to various medical conditions and treatment.
Such information is provided for educational purposes only and is not meant to be
a substitute for the advice of a physician or other healthcare professionals. You
should not use this information for diagnosing a health problem or disease. In order
for you to make intelligent healthcare decisions, you should always consult with
a physician or other healthcare provider for your, or your loved one’s, personal
medical needs. All quotes included in this Web site represent the individual experience
of some doctors, some patients, and their caregivers. Individual responses to treatment
This site is intended for residents of the United States only. Any products discussed
herein may have different product labeling in different countries.
This product information is intended for residents of the United States only.
ZOMIG and ZOMIG-ZMT are registered trademarks of the AstraZeneca group of companies.
© 2014 Impax Pharmaceuticals™, a division of Impax Laboratories,
Inc. All rights reserved. 3027501 PP-ZNS-US-0005 Last updated 07/14