"March 11, 2014 - The U.S. Food and Drug Administration allowed marketing of the first device as a preventative treatment for migraine headaches. This is also the first transcutaneous electrical nerve stimulation (TENS) device specifically "...
Treximet Consumer (continued)
Dizziness, drowsiness, flushing, nausea, and heartburn may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: difficult/painful swallowing, feelings of tingling/numbness/prickling/heat, swelling hands/ankles/feet, sudden/unexplained weight gain, hearing changes (such as ringing in the ears), unusual tiredness.
Tell your doctor immediately if any of these rare but very serious side effects occur: easy bleeding/bruising, change in the amount of urine, blue fingers/toes/nails, feeling of cold hands/feet, mental/mood changes (such as depression), seizures.
Chest/jaw/neck tightness can commonly occur shortly after using sumatriptan. Only rarely are these signs of a serious condition. However, you may not be able to tell them apart from a serious reaction related to a lack of blood flow to the heart, brain, or other parts of the body. Stop taking this medication and seek immediate medical attention if you notice any of the following rare but very serious side effects: shortness of breath, chest/jaw/left arm pain, fainting, fast/irregular/pounding heartbeat, vision changes, weakness on one side of the body, confusion, slurred speech.
This drug may rarely cause serious (possibly fatal) liver disease. If you notice any of the following rare but very serious side effects, stop taking this product and tell your doctor immediately: yellowing eyes/skin, dark urine, persistent nausea/vomiting.
This medication may rarely cause a very serious condition called serotonin syndrome. The risk increases when this medication is taken with certain other drugs such as other triptans used to treat migraine headaches (such as rizatriptan, zolmitriptan), certain antidepressants including SSRIs (such as citalopram, fluoxetine, paroxetine) and SNRIs (such as duloxetine, venlafaxine), or a certain drug to treat obesity (sibutramine). Before taking this drug, tell your doctor if you take any of these medications. Serotonin syndrome may be more likely when you start or increase the dose of any of these medications. Seek immediate medical attention if you develop some of the following symptoms: mental/mood changes (such as hallucinations, restlessness), loss of coordination, fast heartbeat, high fever, sweating, severe nausea/vomiting/diarrhea, twitchy muscles.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash/blisters, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Treximet (sumatriptan and naproxen sodium tablets) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: See also How to Use section.
Before taking this product, tell your doctor or pharmacist if you are allergic to naproxen or to sumatriptan; or to aspirin or other NSAIDs (such as ibuprofen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), heart disease (such as chest pain, previous heart attack), decreased blood flow in the brain (such as previous stroke, transient ischemic attack), blood circulation disease (such as ischemic bowel disease, Raynaud's disease), certain types of headaches (hemiplegic or basilar migraine), liver disease, previous or planned heart bypass surgery (CABG).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, seizures, stomach/intestine/esophagus problems (such as bleeding, ulcers), congestive heart failure, high blood pressure, swelling (edema, fluid retention), a severe loss of body water (dehydration), blood disorders (such as anemia), bleeding or clotting problems, asthma, growths in the nose (nasal polyps).
Tell your doctor if you have the following risk factors for heart disease: diabetes, family history of heart disease, high cholesterol, overweight, smoker, female after menopause, male over age 40.
This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely.
This product contains salt (sodium). Tell your doctor before using this drug if you are limiting your intake of salt.
Before having surgery, tell your doctor or dentist that you are using this medication.
This medicine may cause stomach bleeding. Daily use of alcohol and tobacco may increase your risk for stomach bleeding, especially when combined with this medicine. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information.
This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.
The risk of heart disease, liver disease, kidney disease, and high blood pressure increases with age. Therefore, older adults may be at greater risk for stomach/intestinal bleeding, high blood pressure, and kidney problems while using this product.
Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks (such as miscarriage). Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It is not recommended for use during the first and last trimesters of pregnancy due to possible harm to the unborn baby and interference with normal labor/delivery.
These drugs pass into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding. Avoid breastfeeding for at least 12 hours after any treatment with sumatriptan.
Additional Treximet Information
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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