Naproxen Sodium (na-PROX-en SOE-dee-um), Sumatriptan Succinate (soo-ma-TRIP-tan SUX-i-nate)

Treats migraines. This medicine contains an NSAID.

Brand Name(s):

Treximet

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed. Use only when you have a migraine. Do not use this medicine for regular headaches.
• Swallow the tablet whole. Do not break, crush, or chew it.
• Children 12 years of age or older: If your headache does not improve after the first dose, do not take a second dose. Call your doctor.
• Adults: If your headache does not improve after the first dose, wait at least 2 hours before you take a second dose. Do not take more than 2 tablets in 24 hours.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you have taken an MAO inhibitor in the past 14 days or another migraine medicine within the past 24 hours.
• Do not use aspirin or any other NSAID medicine (including celecoxib, diclofenac, diflunisal, ibuprofen, salsalate) unless your doctor says it is okay.
• Some medicines can affect how sumatriptan/naproxen works. Tell your doctor if you are using any of the following:
  • Cyclosporine, digoxin, lithium, methotrexate, pemetrexed, probenecid
  • Blood pressure medicine
  • Blood thinner (including warfarin)
  • Diuretic (water pill)
  • Medicine to treat depression
  • Steroid medicine

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding. Do not use this medicine during the later part of pregnancy, unless your doctor says it is okay.
• Tell your doctor if you have kidney disease, liver disease, anemia, asthma, bleeding problems, diabetes, fluid retention, high cholesterol, heart rhythm problems, high blood pressure, or a family history of heart disease. Tell your doctor if you have a history of seizures, ulcers, or stomach or bowel bleeding. Tell your doctor if you are on a low-salt diet or if you smoke or drink alcohol.
• This medicine may cause the following problems:
  • Increased risk of blood clots, heart attack, heart rhythm problems, or stroke
  • Stomach or bowel problems (including bleeding, ulcers, or perforation)
  • Serotonin syndrome, when used with certain other medicines
  • Kidney problems
  • Liver problems
  • Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS)
• This medicine may cause a delay in ovulation for women and may affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.
• Your headaches may become worse if you use a headache medicine for 10 or more days per month. Write down how often your headaches occur and how often you use this medicine.
• This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, restlessness, fever, muscle spasms, diarrhea, seeing or hearing things that are not there
• Blistering, peeling, or red skin rash
• Bloody or black, tarry stools, severe stomach pain, vomiting blood or material that looks like coffee grounds
• Change in how much or how often you urinate, painful or difficult urination
• Chest discomfort, jaw or neck tightness
• Chest pain that may spread, trouble breathing, unusual sweating, fainting
• Coughing up blood, numbness or weakness in your arm or leg, or on one side of your body, pain in your lower leg
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fast or slow, pounding, or uneven heartbeat
• Seizure
• Sudden or severe headache, problems with vision, speech, or walking
• Unexplained weight gain, swelling in your hands, ankles, or feet
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Vision changes that are not part of a usual migraine

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088