Naproxen Sodium (na-PROX-en SOE-dee-um), Sumatriptan Succinate (soo-ma-TRIP-tan SUX-i-nate)
Treats migraine headaches. This medicine does not prevent migraines. This medicine contains a triptan and a nonsteroidal anti-inflammatory drug (NSAID).
There may be other brand names for this medicine.
When This Medicine Should Not Be Used
Do not use this medicine if you have had an allergic reaction to sumatriptan, naproxen, aspirin, or other NSAID medicines (such as diclofenac, ibuprofen, Advil®, Celebrex®). Do not use this medicine if you have liver, heart, or blood vessel disease. Tell your doctor if you have high blood pressure that is not under control, a history of heart disease, heart attack, angina, stroke, transient ischemic attack (TIA), ischemic bowel disease, peripheral vascular disease, or coronary artery bypass graft (CABG) surgery. You should not use this medicine to prevent migraine attacks or for hemiplegic or basilar migraines. Do not use this medicine if in the past 2 weeks you have used an MAO inhibitor (MAOI, such as isocarboxazid, phenelzine, selegiline, tranylcypromine, Eldepryl®, Marplan®, Nardil®, or Parnate®). Do not use this medicine if you have taken another migraine headache medicine in the past 24 hours, such as another triptan or an ergot medicine. These medicines include dihydroergotamine (D.H.E. 45®, Migranal®), ergotamine (Cafergot®, Ergomar®, Wigraine®), Imitrex®, almotriptan (Axert?), eletriptan (Relpax®), frovatriptan (Frova®), naratriptan (Amerge®), rizatriptan (Maxalt®), or zolmitriptan (Zomig®).
How to Use This Medicine
- Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
- Swallow the tablet whole. Do not break, crush, or chew it.
- If your headache does not get any better after 1 dose of medicine, do not use a second dose unless your doctor tells you to.
- If your headache does not completely go away or comes back after 1 dose of medicine, wait at least 2 hours before you take another dose.
- Do not take more than 2 doses in 24 hours.
- This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.
How to Store and Dispose of This Medicine
- Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
- Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
- Keep all medicine away from children and never share your medicine with anyone.
Drugs and Foods to Avoid
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.
- Make sure your doctor knows if you are also using aspirin, lithium (Eskalith®, Lithobid®), methotrexate (Rheumatrex®), probenecid (Benemid®), steroid medicine (such as dexamethasone, prednisolone, prednisone, or Medrol®), or a blood thinner (such as warfarin, Coumadin®). Tell your doctor if you are also using certain blood pressure medicines (such as captopril, enalapril, lisinopril, metoprolol, propranolol, Accupril®, Altace®, Inderal®, Lotrel®, or Toprol®) or a diuretic (water pill, such as furosemide, hydrochlorothiazide [HCTZ], torsemide, Demadex®, or Lasix®).
- Tell your doctor if you are also using medicine to treat depression (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, olanzapine, paroxetine, sertraline, venlafaxine, Celexa®, Cymbalta®, Effexor®, Lexapro®, Luvox®, Paxil®, Prozac®, or Zoloft®).
- Do not take any other medicine that contains naproxen or other NSAID medicines, such as celecoxib, ibuprofen, Advil®, or Celebrex®.
Warnings While Using This Medicine
- Make sure your doctor knows if you are pregnant or breastfeeding. Do not use this medicine during the later part of pregnancy unless your doctor tells you to.
- Make sure your doctor knows if you have kidney disease, asthma, bleeding problems, congestive heart failure, or a history of seizures, stomach or bowel bleeding, Crohn disease, or ulcerative colitis. Tell your doctor if you are on a low-salt diet or if you have edema (retaining water).
- This medicine can cause heart problems, including heart attack. This is more likely to happen if you already have heart disease. Tell your doctor if you have any risk factors for heart disease, such as high blood pressure, high cholesterol, smoking, diabetes, or a family history of heart disease. Men over 40 years old, women who are past menopause, and people who are overweight are also more likely to have heart disease.
- Get emergency help right away if you have any symptoms of a heart attack or stroke. Some possible symptoms are chest pain or discomfort, uneven heartbeat, pain that spreads to you arm or jaw, unusual sweating, feeling faint, trouble breathing, slurred speech, or weakness on one side of your body.
- This medicine might cause bleeding or ulcers in your stomach or intestines. This problem can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years of age, are in poor health, or are using certain other medicines (such as a steroid or a blood thinner).
- This medicine may cause a serious condition called serotonin syndrome, when taken with certain medicines. Call your doctor right away if you have a fever, confusion, mental changes, restlessness, fast heartbeat, muscle spasms, trouble walking, nausea, vomiting, or diarrhea.
- Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.
- Stop using this medicine and check with your doctor right away if you have any symptoms of liver problems, such as dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, or yellow skin or eyes.
- You could make your migraine headaches worse if you take migraine medicine too often (more than 10 days every month). Keep track of how often you have migraines and how much medicine you use.
- This medicine may make you dizzy or drowsy. Do not drive, use machines, or do anything else that could be dangerous if you are not alert until you know how this medicine affects you.
- Do not use this medicine if your headache symptoms are different from your usual migraine headache. Call your doctor if your headache is unusual or severe. If your symptoms do not improve or if they get worse, call your doctor.
- Your doctor will need to check your blood or urine at regular visits while you are using this medicine. Be sure to keep all appointments.
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, fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, seeing or hearing things that are not there
- Blistering, peeling, or red skin rash
- Change in how much or how often you urinate
- Chest pain, especially if it spreads to your arms, jaw, back, or neck; trouble breathing; nausea; unusual sweating; faintness
- Coughing up blood, pain in your lower leg (calf)
- Dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach
- Fast, pounding, or uneven heartbeat
- Numbness or weakness in your arm or leg, or on one side of your body
- Severe stomach pain, bloody or black, tarry stools
- Swelling in your hands, ankles, or feet
- Tightness or discomfort in your chest, neck, or jaw
- Tingling, numbness, or cold feeling in your hands or feet
- Unusual bleeding, bruising, or weakness
- Unusual headache, problems with vision, speech, or walking
- Unusual weight gain
- Vomiting of blood or something that looks like coffee grounds
- Yellowing of your skin or the whites of your eyes
If you notice these less serious side effects, talk with your doctor:
- Dizziness or drowsiness
- 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
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