IMITREX®*
(sumatriptan succinate tablets)

Please read this leaflet carefully before you take IMITREX 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 IMITREX Tablets. For further information or advice, ask your doctor or pharmacist.

Information About Your Medicine

The name of your medicine is IMITREX (sumatriptan succinate) Tablets. It can be obtained only by prescription from your doctor. The decision to use IMITREX 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 40 years of age), you should tell your doctor, who should evaluate you for heart disease in order to determine if IMITREX is appropriate for you. Although the vast majority of those who have taken IMITREX have not experienced any significant side effects, some individuals have experienced serious heart problems and, rarely, considering the extensiveness of IMITREX use worldwide, deaths have been reported. In all but a few instances, however, serious problems occurred in people with known heart disease and it was not clear whether IMITREX was a contributory factor in these deaths.

1.   The Purpose of Your Medicine:

IMITREX Tablets are intended to relieve your migraine, but not to prevent or reduce the number of attacks you experience. Use IMITREX Tablets only to treat an actual migraine attack.

2.   Important Questions to Consider Before Taking IMITREX Tablets:

If the answer to any of the following questions is YES or if you do not know the answer, then please discuss it with your doctor before you use IMITREX Tablets.

• Are you pregnant? Do you think you might be pregnant? Are you trying to become pregnant? Are you using inadequate contraception? Are you breastfeeding?
• 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 40 years of age)?
• Have you had a stroke, transient ischemic attacks (TIAs), or Raynaud syndrome?
• Do you have high blood pressure?
• Have you ever had to stop taking this or any other medicine because of an allergy or other problems?
• Are you taking any other migraine medicines, including other 5-HT1 agonists or any other medicines containing ergotamine, dihydroergotamine, or methysergide?
• Are you taking any medicine for depression or other disorders such as monoamine oxidase inhibitors, selective serotonin reuptake inhibitors (SSRIs), or serotonin norepinephrine reuptake inhibitors (SNRIs)? Common SSRIs are citalopram HBr (CELEXA®), escitalopram oxalate (LEXAPRO®), paroxetine (PAXIL®), fluoxetine (PROZAC®/SARAFEM®), olanzapine/fluoxetine (SYMBYAX®), sertraline (ZOLOFT®), and fluvoxamine. Common SNRIs are duloxetine (CYMBALTA®) and venlafaxine (EFFEXOR®).*
• 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 discuss it with your doctor.

3.   The Use of IMITREX Tablets During Pregnancy:

Do not use IMITREX 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 IMITREX Tablets:

For adults, the usual dose is a single tablet swallowed whole with water or other fluids. Do not split tablets.

A second tablet may be taken if your symptoms of migraine come back or if you have a partial response to the initial dose, but not sooner than 2 hours following the first tablet. For a given attack, if you have no response to the first tablet, do not take a second tablet without first consulting with your doctor. Do not take more than a total of 200 mg of IMITREX Tablets in any 24-hour period. The safety of treating an average of more than 4 headaches in a 30-day period has not been established.

5.   Side Effects to Watch for:

• Some patients experience pain or tightness in the chest or throat when using IMITREX Tablets. If this happens to you, then discuss it with your doctor before using any more IMITREX Tablets. If the chest pain is severe or does not go away, call your doctor immediately.
• If you have sudden and/or severe abdominal pain following IMITREX Tablets, call your doctor immediately.
• Some people may have a reaction called serotonin syndrome when they use certain types of antidepressants, SSRIs or SNRIs, while taking IMITREX Tablets. Symptoms may include confusion, hallucinations, fast heartbeat, feeling faint, fever, sweating, muscle spasm, difficulty walking, and/or diarrhea. Call your doctor immediately if you have any of these symptoms after taking IMITREX Tablets.
• 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 IMITREX Tablets unless your doctor tells you to do so.
• Some people may have feelings of tingling, heat, flushing (redness of face lasting a short time), heaviness or pressure after treatment with IMITREX Tablets. A few people may feel drowsy, dizzy, tired, or sick. Tell your doctor of these symptoms at your next visit.
• If you feel unwell in any other way or have any symptoms that you do not understand, you should contact your doctor immediately.

6.   What to Do if an Overdose is Taken:

If you have taken more medicine than you have been told, contact either your doctor, hospital emergency department, or nearest poison control center immediately.

7. Storing Your Medicine:

Keep your medicine in a safe place where children cannot reach it. It may be harmful to children. Do not remove tablets from the packaging until you are ready to use them. Do not store the tablets in any other container.

Store your medicine away from heat and light. Do not store at temperatures above 86°F (30°C), or below 36°F (2°C).

If your medicine 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.

*IMITREX and PAXIL are registered trademarks of GlaxoSmithKline. The other brands listed are trademarks of their respective owners and are not trademarks of GlaxoSmithKline. The makers of these brands are not affiliated with and do not endorse GlaxoSmithKline or its products.

Bookmark this page: