TREXIMET- sumatriptan succinate and naproxen sodium tablet, film coated 
Rebel Distributors Corp

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MEDICATION GUIDE

TREXIMET®[trex' i-met] Tablets

(sumatriptan and naproxen sodium)

What is the most important information I should know about TREXIMET?

TREXIMET, which contains sumatriptan and naproxen sodium [a nonsteroidal anti-inflammatory drug (NSAID)], may increase the chance of a heart attack or stroke that can lead to death. This chance increases:

NSAID-containing medicines, such as TREXIMET, should never be used right before or after a heart surgery called a coronary artery bypass graft (CABG).

NSAID-containing medicines, such as TREXIMET, can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:

The chance of a person getting an ulcer or bleeding increases with:

TREXIMET is not recommended for people with risk factors for heart disease unless a heart exam is done and shows no problems.

The risk factors for heart disease include:

“Serotonin syndrome” is a serious and life-threatening problem that may occur with TREXIMET, especially if used with antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs) or selective norepinephrine reuptake inhibitors (SNRIs).

Commonly used SSRIs are:

Commonly used SNRIs are:

Call your healthcare provider if you have symptoms of serotonin syndrome, which include:

TREXIMET should only be used:

TREXIMET already contains an NSAID (naproxen). Do not use TREXIMET with other medicines to lessen pain or fever without talking to your healthcare provider first, because they may contain an NSAID also.

What is TREXIMET?

TREXIMET is a prescription medicine used to treat migraine attacks in adults. It does not prevent or lessen the number of migraines you have, and it is not for other types of headaches. TREXIMET contains 2 medicines: sumatriptan and naproxen sodium (an NSAID). This Medication Guide provides important information you need to know before taking TREXIMET. It does not take the place of talking with your healthcare provider about your medical condition or your treatment.

How should I take TREXIMET?

Who should not take TREXIMET?

Do not take TREXIMET right before or after heart bypass surgery.

Do not take TREXIMET if you have or have had:

Do not take TREXIMET if you take or have taken an antidepressant medicine called a monoamine oxidase (MAO) inhibitor within the last 2 weeks. Common MAO inhibitors are isocarboxazid (MARPLAN®), phenelzine (NARDIL®), tranylcypromine (PARNATE®), and selegiline (ELDEPRYL®, EMSAM®). Ask your healthcare provider if you are not sure if your medicine is an MAO inhibitor.

Do not take TREXIMET if you have taken other migraine medicines in the last 24 hours such as:

Before starting TREXIMET, tell your healthcare provider about:

Keep a list of your medicines to show to your healthcare provider.

Before starting TREXIMET, tell your healthcare provider if you:

What are the possible side effects of TREXIMET?

Serious side effects include:
  • heart attack
  • heartbeat problems
  • stroke
  • high blood pressure
  • heart failure from body swelling (fluid retention)
  • kidney problems including kidney failure
  • bleeding and ulcers in the stomach and intestine
  • low red blood cells (anemia)
  • life-threatening skin reactions
  • life-threatening allergic reactions
  • liver problems including liver failure
  • asthma attacks in people who have asthma
  • loss of blood circulation to areas of your body
  • serotonin syndrome (See list of symptoms in “What is the most important information I should know about TREXIMET?”)

Other side effects include:

  • pain, tightness, or pressure in the chest, neck, and throat
  • stomach pain
  • constipation
  • diarrhea
  • gas
  • heartburn
  • nausea
  • vomiting
  • dizziness
  • drowsiness
  • tiredness
  • weakness
  • tingling and numbness
  • unusual body sensations
  • redness of face (flushed)

Get emergency help right away if you have any of the following symptoms:

Stop TREXIMET and call your healthcare provider right away if you have any of the following symptoms:

Tell your healthcare provider if you have any side effects that bother you or do not go away. These are not all of the side effects of TREXIMET. For more information ask your healthcare provider.

Call your healthcare provider for medical advice about side effects. You may report side effects at FDA at 1-800-FDA-1088.

How should I store TREXIMET?

General information about TREXIMET

What are the ingredients in TREXIMET?

Active ingredients: sumatriptan succinate and naproxen sodium

Inactive ingredients: croscarmellose sodium, dextrose monohydrate, dibasic calcium phosphate, FD&C Blue No. 2, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, sodium bicarbonate, sodium carboxymethylcellulose, talc, and titanium dioxide.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

June 2009 TRX:3MG

TREXIMET is a trademark of GlaxoSmithKline. IMITREX, PARNATE, and PAXIL are registered trademarks of GlaxoSmithKline.

The other brands listed are trademarks of their respective owners and are not trademarks of GlaxoSmithKline. The makers of these brands are not affiliated with and do not endorse GlaxoSmithKline or its products.

GlaxoSmithKline

Research Triangle Park, NC 27709

©2009, GlaxoSmithKline. All rights reserved.

December 2009 TRX:5PI

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

Revised: 09/2011
 
Rebel Distributors Corp