Sumatriptan Succinate, Naproxen Sodium Oral tablet

What is this medicine?

NAPROXEN; SUMATRIPTAN (na PROS en; soo ma TRIP tan) is used to treat migraines with or without aura. An aura is a strange feeling or visual disturbance that warns you of an attack. This medicine is not used to prevent migraines.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• angina

• diabetes

• heart disease

• hemiplegic or basilar migraine

• high blood pressure

• high cholesterol

• if you frequently drink alcohol containing drinks

• irregular heartbeat

• ischemic bowel disease

• kidney disease

• liver disease

• low blood counts, like low white cell, platelet, or red cell counts

• lung or breathing disease, like asthma

• peripheral vascular disease like intermittent claudication

• seizures

• stomach problems

• stroke

• take medicines that treat or prevent blood clots

• taken an MAOI like Carbex, Eldepryl, Marplan, Nardil, or Parnate in last 14 days

• an unusual or allergic reaction to Naproxen; Sumatriptan, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Do not cut, crush, or chew this medicine. Do not take it more often than directed.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 12 for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply; this medicine is not for regular use.

What may interact with this medicine?

What drug(s) may interact with Naproxen; Sumatriptan?

Do not take this medicine with any of the following medications:

• amphetamine

• cidofovir

• cocaine

• dextroamphetamine

• ergot alkaloids like dihydroergotamine, ergonovine, ergotamine, methylergonovine

• feverfew

• ketorolac

• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

• medicines for migraine headache like almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan

• tryptophan

This medicine may also interact with the following medications:

• alcohol

• angiotensin-converting enzyme inhibitors (ACE inhibitors) like captopril, enalapril, lisinopril, and ramipril

• aspirin and aspirin-like medicines

• diuretics

• duloxetine

• lithium

• medicines for blood pressure like amlodipine, felodipine, nifedipine

• medicines that treat or prevent blood clots like warfarin, enoxaparin, and dalteparin

• methotrexate

• NSAIDS, medicines for pain and inflammation, like ibuprofen or naproxen

• probenecid

• selective serotonin reuptake inhibitors such as citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, and sertraline

• steroid medicines like prednisone or cortisone

• venlafaxine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Only use this medicine for a migraine headache. Use it if you get warning symptoms or at the start of a migraine attack. This medicine is not for regular use to prevent migraine headaches. Tell your doctor or health care professional if your pain does not get better. Talk to your doctor before taking another medicine for pain. Do not treat yourself.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.

Do not take other medicines that contain aspirin, ibuprofen, or naproxen with this medicine. Side effects such as stomach upset, nausea, or ulcers may be more likely to occur. Many medicines available without a prescription should not be taken with this medicine.

This medicine does not prevent heart attack or stroke. In fact, this medicine may increase the chance of a heart attack or stroke. The chance may increase with longer use of this medicine and in people who have heart disease. If you take aspirin to prevent heart attack or stroke, talk with your doctor or health care professional.

This medicine can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Do not smoke cigarettes or drink alcohol. These increase irritation to your stomach and can make it more susceptible to damage from this medicine. Ulcers and bleeding can happen without warning symptoms and can cause death.

This medicine can cause you to bleed more easily. Try to avoid damage to your teeth and gums when you brush or floss your teeth. If you have any dental work done, tell your dentist you are receiving this medicine.

If you take migraine medicines for 10 or more days a month, your migraines may get worse. Keep a diary of headache days and medicine use. Contact your healthcare professional if your migraine attacks occur more frequently.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• fast, irregular heartbeat

• feeling of chest heaviness or pressure

• general ill feeling or flu-like symptoms

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• seizures

• signs and symptoms of bleeding such as bloody or black, tarry stools; red or dark-brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eye, gums, or nose

• signs and symptoms of a blood clot such as breathing problems; changes in vision; chest pain; severe, sudden headache; pain, swelling, warmth in the leg; trouble speaking; sudden numbness or weakness of the face, arm or leg

• swelling of the ankles, feet, hands

• severe stomach pain

• tingling, pain, or numbness in the face, hands or feet

• unusually weak or tired

• yellowing of eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• dry mouth

• headache

• heartburn

• nausea, vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.