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|Sumatriptan Tablets

Sumatriptan

Sumatriptan is used for:

The treatment of migraine headaches with or without aura (eg, flashing lights, wavy lines, dark spots). It may also be used for other conditions as determined by your doctor.

Sumatriptan is a serotonin 5-HT ₁receptor agonist ("triptan"). It works by narrowing blood vessels in the brain, which helps to relieve migraines.

Do NOT use Sumatriptan if:

• you are allergic to any ingredient in Sumatriptan
• you have a history of ischemic heart disease (eg, angina, heart attack), coronary artery disease (CAD), other moderate to severe heart problems, brain blood vessel disease (eg, stroke, transient ischemic attack), or other blood vessel disease (eg, Raynaud syndrome, ischemic bowel disease)
• you have uncontrolled high blood pressure or severe liver problems
• you have certain types of migraines (eg, hemiplegic, basilar)
• you are taking or have taken a monamine oxidase inhibitor (MAOI) (eg, phenelzine) within the past 14 days
• you have used certain other migraine medicines within the past 24 hours. These include an ergot derivative (eg, dihydroergotamine, methysergide) or another serotonin 5-HT ₁ receptor agonist (eg, eletriptan, rizatriptan)
• you are taking sibutramine

Contact your doctor or health care provider right away if any of these apply to you.

Before using Sumatriptan:

Some medical conditions may interact with Sumatriptan. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have history of liver or kidney problems, seizures (eg epilepsy), heart problems, or other types of headaches (eg, cluster headaches)
• if you have shortness of breath, chest pain, or a history of high blood pressure, heart attack, stroke, high cholesterol, diabetes, or smoking
• if you are a woman who is past menopause
• if you are a man who is older than 40 years of age
• if you are very overweight
• if a family member has had heart disease

Some MEDICINES MAY INTERACT with Sumatriptan. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), serotonin norepinephrine reuptake inhibitors (eg, duloxetine), orsibutramine because the risk of a serious side effect called serotonin syndrome may be increased. Symptoms of serotonin syndrome may include mental or mood changes, hallucinations, fast heartbeat, fever, loss of coordination, muscle spasms, increased sweating, nausea, vomiting, or diarrhea
• MAOIs (eg, phenelzine) because they may increase the risk of Sumatriptan"s side effects
• Ergot derivatives (eg, dihydroergotamine, methysergide) or other serotonin 5-HT ₁ receptor agonists (eg, eletriptan, rizatriptan) because the risk of their side effects may be increased by Sumatriptan

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sumatriptan may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Sumatriptan:

Use Sumatriptan as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Sumatriptan. Talk to your pharmacist if you have questions about this information.
• Take Sumatriptan by mouth with or without food.
• Swallow Sumatriptan whole. Do not break, crush, or chew before swallowing.
• It is best to take a dose of Sumatriptan as soon as you notice symptoms of a migraine attack.
• If your migraine symptoms go away and then come back, or if you have a partial response to the first dose, you may take a second dose as directed by your doctor. Wait at least 2 hours between doses.
• If your symptoms do not improve after the first dose, do not take a second dose for the same attack. Contact your doctor.
• Do not take more than the amount prescribed by your doctor in a 24-hour period or treat more than 4 headaches within 30 days without checking with your doctor.
• If you miss a dose of Sumatriptan and you still have a headache, follow your doctor"s dosing instructions. Contact your doctor immediately if you are unsure of what to do if you miss a dose. Do not take Sumatriptan more often than prescribed. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Sumatriptan.

Important safety information:

• Sumatriptan may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Sumatriptan with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Rarely, serious heart problems (eg, heart attack, irregular heartbeat) have been reported within a few hours of using Sumatriptan. Contact your doctor at once if fast or irregular heartbeat; chest, jaw, or neck pain or numbness; numbness of an arm or leg; severe stomach pain, dizziness, or vomiting; fainting; or vision changes occur. Discuss any questions or concerns with your doctor.
• Sumatriptan should not be used to prevent or reduce the number of migraine headaches you have. If you have a headache that is different than your usual migraine headaches, check with your doctor before using Sumatriptan.
• Lab tests, including heart function tests, may be performed while you use Sumatriptan. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Sumatriptan should not be used in the ELDERLY; the risk of serious side heart and blood pressure side effects may be increased.
• Sumatriptan should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: It is not known if Sumatriptan can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Sumatriptan while you are pregnant. Sumatriptan is found in breast milk. If you are or will be breast-feeding while you use Sumatriptan, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Sumatriptan:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Burning; dizziness; drowsiness; feeling of heaviness or pressure; muscle aches; numbness or tingling of the skin; sick feeling; tingling; tiredness; warm/hot sensation.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody diarrhea; chest pain; confusion; fainting; fast or irregular heartbeat; hearing problems; numbness or tingling of an arm or leg; one-sided weakness; pain, tightness, or pressure in the jaw, neck, or chest; seizures; severe headache, dizziness, or vomiting; severe or prolonged flushing; severe stomach pain; shortness of breath; speech changes; very cold or blue fingers or toes; vision changes or loss of vision; wheezing.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include blue skin or lips; chest pain; dilated pupils; loss of coordination; paralysis; redness of the fingers or toes; seizures; slow or difficult breathing; tremor.

Store Sumatriptan between 36 and 86 degrees F (2 and 30 degrees C). Store away from heat, moisture, and light. Do not freeze. Do not store at temperatures above 86 degrees F (30 degrees C). Do not store in the bathroom. Keep Sumatriptan in the case provided. Throw away expired medicine as directed by your doctor (the expiration date is printed on the treatment pack). Keep Sumatriptan out of the reach of children and away from pets.

General information:

• If you have any questions about Sumatriptan, please talk with your doctor, pharmacist, or other health care provider.
• Sumatriptan is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is summary only. It does not contain all information about Sumatriptan. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.