Zolmitriptan

What it is used for

Zolmitriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use Only use zolmitriptan tablets if a clear diagnosis of migraine has been established. If a patient has no response to zolmitriptan tablets treatment for the first migraine attack, reconsider the diagnosis of migraine before zolmitriptan tablets are administered to treat any subsequent attacks.

Zolmitriptan tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of zolmitriptan tablets have not been established for cluster headache.

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 take 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. This medicine was prescribed for you to treat your particular condition and should not be used by others or for any other condition.

• 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.
• Important Questions to Consider Before Taking 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. Remember, if you answered YES to any of the above questions, then you must discuss it with your doctor.
  • 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)?
  • Have you had a stroke or problems with your blood circulation?
  • 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?
  • If you are taking ZOMIG-ZMT®, are you sensitive to phenylalanine (a component of the artificial sweetener aspartame)?
  • 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 5-HT 1 agonists (triptans) or migraine medications containing ergotamine, dihydroergotamine, or methysergide?
  • Are you taking selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), two types of drugs for depression or other disorders? Common SSRIs are CELEXA ® (citalopram HBr), LEXAPRO ® (escitalopram oxalate), PAXIL ® (paroxetine), PROZAC ® (fluoxetine), SYMBYAX ® (olanzapine/fluoxetine), ZOLOFT ® (sertraline), SARAFEM ® (fluoxetine), and LUVOX ® (fluvoxamine). Common SNRIs are CYMBALTA ® (duloxetine) and EFFEXOR ® (venlafaxine).
  • Are you taking cimetidine for gastrointestinal symptoms?
  • 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?
• 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.
• How to Use ZOMIG Tablets and ZOMIG-ZMT Orally Disintegrating 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 the conventional film-coated, scored 2.5 mg tablet in half. It is not recommended to break the ZOMIG-ZMT Tablet. If your headache comes back after your initial dose, a second dose may be administered anytime after 2 hours of taking 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 take more than a total of 10 mg of ZOMIG in any 24-hour period. Discard any unused tablets or its portion that have been removed from the blister packaging. Do not take ZOMIG with any other drug in the same class (triptans) within 24 hours or within 24 hours of taking ergotamine-type medications such as ergotamine, dihydroergotamine or methysergide to treat your migraine. Additionally for ZOMIG-ZMT Tablets, the blister pack should be peeled open and the orally disintegrating tablet placed on the tongue, where it will dissolve and be swallowed with the saliva.
• Side Effects to Watch for:
  • Some patients experience pain or tightness in the chest or throat, including muscle aches and pains, when using ZOMIG. If this happens to you, then discuss it with your doctor before using any more ZOMIG. If the chest pain is severe or does not go away, call your doctor immediately. As with other drugs in this class (triptans), there have been very rare reports of heart attack occurring in patients with and without risk factors for heart and blood vessel disease.
  • Some people experience: alterations of heart rate; temporary increase in blood pressure; sudden and severe stomach pain. Call your doctor immediately if you have any of these symptoms after taking ZOMIG.
  • 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 unless your doctor tells you to do so.
  • Some people may have feelings of dry mouth, tingling, heat, heaviness, or pressure after treatment with ZOMIG. A few people may feel drowsy, dizzy, tired, or sick. Tell your doctor immediately if you have symptoms that you do not understand.
  • Some people may have a reaction called serotonin syndrome, which can be life-threatening, when they use ZOMIG. In particular, this reaction may occur when they use ZOMIG together with certain types of antidepressants known as SSRIs or SNRIs. Symptoms may include confusion, hallucinations, fast heart beat, feeling faint, fever, sweating, muscle spasm, difficulty walking, and/or diarrhea. Call your doctor immediately if you have any of these symptoms after taking ZOMIG.
• 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.
• 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 light and 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.

ZOMIG and ZOMIG-ZMT are registered trademarks of the AstraZeneca group of companies.

Other brands mentioned are trademarks of their respective owners and are not trademarks of the AstraZeneca group of companies. The makers of these brands are not affiliated with AstraZeneca or its products.

© AstraZeneca 2007, 2008

ZOMIG ® (zolmitriptan) Tablets

Manufactured for:

AstraZeneca Pharmaceuticals LP

Wilmington, Delaware 19850

By: IPR Pharmaceuticals, Inc.

Canóvanas, PR 00729

ZOMIG-ZMT ® (zolmitriptan) Orally Disintegrating Tablets

Manufactured for:

AstraZeneca Pharmaceuticals LP

Wilmington, Delaware 19850

By: CIMA Labs, Inc.

Eden Prairie, Minnesota 55344

Rev 10/08 SIC 30086–05