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Zomig

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PATIENT INFORMATION

The following wording is contained in a separate leaflet provided for patients.
 
ZOMIG® (zolmitriptan) Tablets
Patient Information about ZOMIG (Zo-mig) for Migraines
Generic Name: zolmitriptan (zol-mi-trip-tan)

Information for the Consumer on ZOMIG (zolmitriptan) Tablets

Please read this leaflet carefully before you administer ZOMIG Tablets. This provides a summary of the information available on your medicine. Please do not throw away this leaflet until you have finished your medicine. You may need to read this leaflet again. This leaflet does not contain all the information on ZOMIG Tablets. For further information or advice, ask your doctor or pharmacist.

Information About Your Medicine

The name of your medicine is ZOMIG Tablets. It can be obtained only by prescription from your doctor. The decision to use ZOMIG Tablets is one that you and your doctor should make jointly, taking into account your individual preferences and medical circumstances. If you have risk factors for heart disease (such as high blood pressure, high cholesterol, obesity, diabetes, smoking, strong family history of heart disease, or you are postmenopausal or a male over the age of 40), you should tell your doctor, who should evaluate you for heart disease in order to determine if ZOMIG Tablets are appropriate for you.

1. The Purpose of Your Medicine: ZOMIG Tablets are intended to relieve your migraine, but not to prevent or reduce the number of attacks you experience. Use ZOMIG Tablets only to treat an actual migraine attack.

2. Important Questions to Consider Before Using ZOMIG Tablets: If the answer to any of the following questions is YES or if you do not know the answer, then you must discuss it with your doctor before you use ZOMIG Tablets.

  • Do you have any chest pain, heart disease, shortness of breath, or irregular heartbeats? Have you had a heart attack?
  • Do you have risk factors for heart disease (such as high blood pressure, high cholesterol, obesity, diabetes, smoking, strong family history of heart disease, or you are postmenopausal or a male over the age of 40)?
  • Do you have high blood pressure?
  • Are you pregnant? Do you think you might be pregnant? Are you trying to become pregnant? Are you not using adequate contraception? Are you breast feeding an infant?
  • Have you ever had to stop taking this or any other medication because of an allergy or other problems?
  • Are you taking any other migraine medications, including 5HT1 agonist or migraine medications containing ergotamine, dihydroergotamine, or methysergide?
  • Are you taking any medication for depression (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors [SSRIs])?
  • Have you had or do you have, any disease of the liver or kidney?
  • Have you had or do you have, epilepsy or seizures?
  • Is this headache different from your usual migraine attacks?
    •

    Remember, if you answered YES to any of the above questions, then you must discuss it with your doctor.

    3. The Use of ZOMIG Tablets During Pregnancy: Do not use ZOMIG Tablets if you are pregnant, think you might be pregnant, are trying to become pregnant, or are not using adequate contraception, unless you have discussed this with your doctor.

    4. How to Use ZOMIG Tablets: Adults should be started on a 2.5 mg dose or lower administered by mouth. A dose lower than 2.5 mg can be achieved by manually breaking a 2.5 mg tablet in half. If your headache comes back after your initial dose, a second dose may be administered anytime after 2 hours of administering the dose. For any attack where you have no response to the first dose, do not take a second dose without first consulting with your doctor. Do not administer more than a total of 10 mg of ZOMIG Tablets in any 24-hour period. Discard any unused tablets or its portion that have been removed from the blister packaging.

    5. Side Effects to Watch for:

  • Some patients experience pain or tightness in the chest or throat when using ZOMIG Tablets. If this happens to you, then discuss it with your doctor before using any more ZOMIG Tablets. If the chest pain is severe or does not go away, call your doctor immediately.
  • Shortness of breath; wheeziness; heart throbbing; swelling of eyelids, face, or lips; or a skin rash, skin lumps, or hives happens rarely. If it happens to you, then tell your doctor immediately. Do not take any more ZOMIG Tablets unless your doctor tells you to do so.
  • Some people may have feelings of tingling, heat, heaviness or pressure after treatment with ZOMIG Tablets. A few people may feel drowsy, dizzy, tired, or sick. Tell your doctor immediately if you have symptoms that you do not understand.

    • 6. What to Do if an Overdose Is Taken: If you have taken more medication than you have been told, contact either your doctor, hospital emergency department, or nearest poison control center immediately. This medicine was prescribed for your particular condition and should not be used by others or for any other condition.

    7. Storing Your Medicine: Keep your medicine in a safe place where children cannot reach it. It may be harmful to children. Store your medication away from heat, light, moisture and at a controlled room temperature. If your medication has expired (the expiration date is printed on the treatment pack), throw it away as instructed. If your doctor decides to stop your treatment, do not keep any leftover medicine unless your doctor tells you to. Throw away your medicine as instructed. Be sure that discarded tablets are out of the reach of children.

    Also see WARNINGS, CONTRAINDICATIONS, and PRECAUTIONS.

    Brand Name: Zomig
    Generic Name: Zolmitriptan

    Report Problems to the Food and Drug Administration

     

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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