Treximet Warnings and Precautions (Cont.)

• Treximet can interact with certain medications (see Treximet Drug Interactions).
   
• Treximet has been reported to increase the risk of heart attacks or strokes. You should not take Treximet if you have heart disease or a history of a heart attack, stroke, or transient ischemic attack (TIA or "mini-stroke").

If you have risk factors for heart disease (see Heart Disease Risk Factors), it is also strongly recommended that you take your first dose of Treximet in your healthcare provider's office. This is so your healthcare provider can monitor your heart.

• In some cases, a stroke or transient ischemic attack can be misdiagnosed as a migraine. Your healthcare provider should make sure you are not having a stroke, especially if you have never had migraines in the past (see Stroke Symptoms for more information on the symptoms of a stroke).
   
• Treximet can cause blood vessels to spasm, including in the arms, legs, or colon (large intestine). This can cause a decrease in blood flow to these areas. Symptoms will vary based on the location. For example, a spasm in the colon can lead to severe abdominal pain or bloody diarrhea.
   
• Taking Treximet with certain antidepressants, including selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), can increase your risk of a dangerous group of symptoms called serotonin syndrome. Do not use Treximet with depression medications without first discussing it with your healthcare provider. Contact your healthcare provider immediately if you have any possible symptoms of serotonin syndrome, including:

• Confusion
• Seeing or hearing things that are not really there (hallucinations)
• Fast heartbeat (tachycardia)
• Feeling faint
• Fever
• Sweating
• Muscle spasms
• Difficulty walking
• Diarrhea.

• Treximet can cause an increase in blood pressure. You should not take Treximet if you have untreated high blood pressure (hypertension).
   
• Treximet can worsen congestive heart failure.
   
• Because Treximet contains naproxen, a nonsteroidal anti-inflammatory drug (NSAID), it may increase the risk of bleeding, including dangerous internal bleeding. Be sure to let your healthcare provider know if you develop signs of bleeding in the digestive tract, such as:

• Dark, tarry stools
• Vomiting blood (which may sometimes look like coffee grounds)
• Severe heartburn or indigestion
• Bloody diarrhea.

• Because Treximet contains naproxen, it can worsen (or even cause) kidney problems. If your kidneys are not functioning well, Treximet may not be a good choice for you.
   
• Treximet is considered a pregnancy Category C medication. This means that Treximet may not be safe for use during pregnancy. Talk to your healthcare provider before using Treximet if you are pregnant (see Treximet and Pregnancy for more information).
   
• Treximet passes through breast milk. Therefore, if you are breastfeeding or plan to start breastfeeding, be sure to talk with your healthcare provider about this.
   
• If you have chest pain or jaw or neck tightness after taking Treximet, contact your healthcare provider immediately. These side effects are fairly common with Treximet and are not usually serious. However, your healthcare provider may need to make sure you are not having heart problems.
   
• Tell your healthcare provider if you have liver problems (including liver failure or cirrhosis) or kidney problems (including kidney failure) before taking Treximet. This is because Treximet is removed from the body through the liver and kidneys.
   
• There have been rare cases of seizures in people taking sumatriptan (one of the components of Treximet). If you have a history of seizures, talk to your healthcare provider before starting Treximet.
   
• People with asthma may be more likely to be sensitive or allergic to naproxen, one of the components of Treximet.
   
• Treximet may cause changes in the eyes or vision problems. Tell your healthcare provider if you have eye or vision changes.