Sumatriptan/Naproxen Oral Tablet (SUMATRIPTAN/NAPROXEN SODIUM - ORAL)

Instructions

Swallow the medicine without crushing or chewing it.

Keep the medicine in its original container.

Sit or stand upright for 10 minutes after taking the medicine. Do not lie down.

Swallow with a full glass (8 oz) of water unless your doctor gives you different instructions.

You may take with food to prevent stomach upset.

Store at room temperature away from heat, light, and moisture. Do not keep in the bathroom.

Keep the desiccant (drying) packet in the bottle and keep the bottle closed tightly.

This medicine should be used after a migraine headache starts. It should not be used to prevent a migraine headache.

If your headache improves but does not completely disappear after taking this medicine, you may need a second dose.

If you need to take a second dose, wait at least 2 hours after taking your first dose.

Drink plenty of water while on this medicine.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Tell your doctor if symptoms do not get better or if they get worse.

Talk to your doctor before taking other medicines, including aspirins and ibuprofen containing products. Speak to your doctor about which medicines are safe to use while you are on this medicine.

Keep all appointments for medical exams and tests while on this medicine.

Do not take the medicine more than twice during 24 hours.

Brand Name(s): Treximet

Generic Name: Sumatriptan/Naproxen

Cautions

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

This medicine is associated with an increased risk of serious heart problems, heart attack, and stroke. Please speak with your doctor about the risks and benefits of using this medicine. Contact your doctor immediately if you experience chest pain or difficulty breathing.

This medicine may cause serious bleeding from the stomach or bowels. Stop this medicine and call your doctor immediately if you see any signs of bleeding. Bleeding can cause pain in the stomach, vomiting up liquid that looks like coffee grounds, and red or dark tarry stools.

Do not use the medication any more than instructed.

If possible, avoid using with alcohol, marijuana, or other medicines that can cause dizziness or drowsiness. These include allergy/cold products, muscle relaxers, sleep aids, and pain relievers.

Your ability to stay alert or to react quickly may be impaired by this medicine. Do not drive or operate machinery until you know how this medicine will affect you.

Avoid smoking while on this medicine. Smoking may increase your risk for stomach bleeding.

This medicine passes into breast milk. Ask your doctor before breastfeeding.

This medicine can hurt a new baby in the womb. If you become pregnant while on this medicine, tell your doctor immediately. Your doctor may switch you to a different medicine.

If you have had a heart attack or a stroke within the past 6 months, talk to your doctor before using this medicine.

Do not share this medicine with anyone who has not been prescribed this medicine.

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• dizziness or drowsiness
• feeling of heat or flushing
• numbness or tingling in hands and feet
• high blood pressure
• nausea
• stomach upset or abdominal pain

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• bleeding or bruising
• chest or jaw pain
• coughing up blood or vomit that looks like coffee grounds
• swelling of the legs, feet, and hands
• fainting
• fever
• swelling in the neck or throat
• cold hands or feet
• hallucinations (unusual thoughts, seeing or hearing things that are not real)
• fast or irregular heart beats
• signs of kidney damage (such as change in urine color or bubbly urine)
• signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
• muscle trembling
• pale or blue skin, lips or fingernails
• restlessness
• ringing in the ears
• shortness of breath
• bloody or dark, tarry stools
• symptoms of stroke (such as one-sided weakness, slurred speech, confusion)
• excessive or unusual sweating
• blurring or changes of vision
• severe or persistent vomiting
• sudden or unexplained weight gain

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.