Sumatriptan Succinate/Naproxen Sodium, Oral

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KEY POINTS

• This medicine is taken by mouth to treat migraine headaches. It will not prevent migraine headaches or reduce the number you may have. Take it exactly as directed.
• NSAIDs may increase the chance of a heart attack or stroke that can lead to death. This medicine may cause ulcers and bleeding in the stomach and intestines at any time during treatment.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• This medicine may cause life-threatening problems if you take this medicine with certain other medicines. Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antimigraine/antiinflammatory

Generic and brand names: sumatriptan succinate/naproxen sodium, oral; Treximet Tablets

What is this medicine used for?

This medicine is taken by mouth to relieve the pain of migraine headaches in adults. It will not prevent migraine headaches or reduce the number you may have. This medicine is not intended to treat other types of headaches.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A bleeding disorder
• A heart attack, irregular heartbeat, heart failure, angina, or other heart disease
• A stroke or transient ischemic attack (TIA)
• Asthma
• Cluster headaches
• Hemiplegic or basilar migraine headaches
• Liver, kidney, or bowel disease
• Peripheral vascular disease or Raynaud syndrome (problems with blood circulation)
• Seizures
• Stomach or intestinal ulcers or bleeding
• Uncontrolled high blood pressure

Also, tell your healthcare provider if you have recently had or are scheduled to have heart bypass surgery. You must not take this medicine if you have had or are scheduled to have coronary artery bypass graft (CABG) surgery.

Talk with your healthcare provider if you have any risk factors for heart disease such as diabetes, high cholesterol, smoking, being overweight, or a family history of heart disease or stroke. Women who have had a hysterectomy or are past menopause and men over the age of 40 are also at risk for heart disease.

Taking this medicine within 1 to 14 days of taking certain other medicines may cause life-threatening side effects. These medicines include some antidepressants, antibiotics, antifungal medicines, antiviral medicines, medicines to treat migraines, pain medicines, some cough medicines, St. John’s wort, and others. It is very important to tell your provider ALL of the medicines that you have taken in the past 2 weeks.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. Do not take this medicine during the last 3 months of pregnancy. It is not known if this medicine will harm an unborn baby. It has been reported to cause birth defects in animals. You may need to stop breast-feeding while taking this medicine.

How do I use it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or take it more often than prescribed. If you are not sure of the directions for taking this medicine, ask your healthcare provider or pharmacist to explain.

Check with your healthcare provider before using this medicine in children under the age of 12.

Take 1 dose with water when you start getting a migraine. Swallow the tablets whole. Do not break, crush, or chew the tablets. If approved by your healthcare provider, you may take a second dose at least 2 hours after the first dose if the migraine returns.

If the first dose is not effective, DO NOT take a second dose unless your healthcare provider approves. Do not take more than 2 tablets in a 24-hour period. Do not take other migraine medicines within 24 hours of a dose of this medicine. Overuse of migraine headache medicine can make your headaches worse.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: black bloody bowel movements, blue-colored lips or fingernails, confusion, drowsiness, fainting, lack of coordination, large pupils, nausea, seizures, shallow breathing, slow breathing, stomach pain, tremors, trouble breathing, vomiting blood, weakness, coma.

What should I watch out for?

Warning: This medicine may cause ulcers and bleeding in the stomach and intestines at any time during treatment. This may happen without warning symptoms. If you have stomach pain, or bloody or black tarry bowel movements, stop taking this medicine and contact your healthcare provider right away.

This medicine has been linked with increased risk for high blood pressure. NSAIDs may increase the chance of a heart attack or stroke that can lead to death. This chance increases if you:

• Use NSAIDs for a long time
• Have heart disease

Talk with your healthcare provider about this.

You may have swelling of the ankles, feet, or hands while taking this medicine. If this becomes bothersome, contact your healthcare provider.

This medicine may cause a life-threatening problem called serotonin syndrome if you take it with certain other medicines, such as antidepressants, migraine medicines, pain medicines, some cough medicines, and St. John’s wort. Make sure that your providers know ALL of the medicines that you take. Contact your healthcare provider right away if you have:

• Restlessness
• Hallucinations
• Loss of coordination or trouble walking
• Fast heart beat
• Rapid changes in blood pressure
• Increased body temperature
• Nausea and vomiting
• Stiff muscles
• Diarrhea

You should not use this medicine for more than 5 days per month. Taking too much of this medicine, or taking it too often, can cause overuse or rebound headaches. Tell your healthcare provider if you need to use the medicine more often, if the medicine is not working as well, if you have headaches more often, or if your headaches get worse.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

This medicine may cause an allergic reaction in people who have asthma or who have had allergic reactions to aspirin or other pain medicines. If you develop hives, itching, a rash, tightness in your chest, or trouble breathing, stop taking this medicine and contact your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.

Contact your healthcare provider if you notice any change in vision.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; chest pain or tightness in your chest; trouble breathing; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Jaw or neck tightness; chest pain; irregular or fast heartbeat; hallucinations; sudden or severe stomach pain; bloody diarrhea; pale or blue-colored hands or feet; severe headache; vision changes; unusual bruising or bleeding, swelling in the arms or legs, or any unexplained swelling; blisters or severe rash, yellowing of your skin or eyes.

Other: Nausea; vomiting; diarrhea; dizziness; drowsiness; depression; tiredness; ringing in the ears; nervousness; tremor; flushing or tingling sensation; muscle or joint pain; sore throat; dry mouth; constipation; sweating; eye pain; weakness; confusion.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• ACE inhibitors such as benazepril (Lotensin), captopril, enalapril (Vasotec), fosinopril, lisinopril (Prinivil, Zestril), moexipril (Univasc), quinapril (Accupril), ramipril (Altace), and trandolapril (Mavik)
• Aliskiren (Tekturna) and aliskiren/hydrochlorothiazide (Tekturna HCT)
• Angiotensin receptor blockers (ARBs) such as azilsartan (Edarbi), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), and valsartan (Diovan)
• Antidepressants such as citalopram (Celexa), desvenlafaxine (Pristiq), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), levomilnacipran (Fetzima), nefazodone, sertraline (Zoloft), and venlafaxine (Effexor)
• Aspirin and other salicylates
• Beta blockers such as atenolol (Tenormin), bisoprolol (Zebeta), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), nebivolol (Bystolic), and timolol
• Diuretics (water pills) such as bumetanide, ethacrynic acid (Edecrin), furosemide (Lasix), hydrochlorothiazide (Microzide), and torsemide (Demadex)
• Ergot medicines such as bromocriptine (Cycloset, Parlodel), cabergoline, dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar), and methylergonovine (Do not take these within 24 hours of a dose of this medicine.)
• Linezolid (Zyvox)
• Lithium (Lithobid)
• Lorcaserin (Belviq)
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), clopidogrel (Plavix), dabigatran (Pradaxa), dalteparin (Fragmin), dipyridamole (Persantine), enoxaparin (Lovenox), fondaparinux (Arixtra), heparin, prasugrel (Effient), rivaroxaban (Xarelto), ticagrelor (Brilinta), and warfarin (Coumadin)
• Methotrexate (Otrexup, Rasuvo, Rheumatrex, Trexall)
• Metoclopramide (Metozolv, Reglan)
• Milnacipran (Savella)
• Natural remedies such as alfalfa, anise, bilberry, chamomile, fenugreek, garlic, ginkgo biloba, ginseng, glucosamine, green tea, horse chestnut, kava, licorice, red clover, SAMe, St. John’s wort, turmeric, and willow
• Nausea medicines such as alosetron (Lotronex), dolasetron (Anzemet), granisetron (Sancuso), ondansetron (Zofran), and palonosetron (Aloxi)
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as celecoxib (Celebrex), diclofenac (Cambia, Voltaren, Zipsor), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Other migraine medicines such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Alsuma, Imitrex, Sumavel), and zolmitriptan (Zomig) (Do not take these within 24 hours of a dose of this medicine.)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Probenecid
• Procarbazine (Matulane)
• Propranolol (Hemangeol, Inderal, InnoPran)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.