TREXIMET- sumatriptan succinate and naproxen sodium tablet, film coated 
GlaxoSmithKline LLC

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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?

1. TREXIMET may increase your chance of a heart attack or stroke that can lead to death. TREXIMET contains 2 medicines: sumatriptan and naproxen sodium (a nonsteroidal anti-inflammatory drug [NSAID]).

Your chance of a heart attack or stroke increases:

with longer use of NSAID medicines
if you have heart disease.

2. TREXIMET should never be used right before or after a heart surgery called a coronary artery bypass graft (CABG).

3. TREXIMET can cause ulcers and bleeding in the stomach and intestines at any time during your treatment.

Ulcers and bleeding:

can happen without warning symptoms
may cause death.

Your chance of getting an ulcer or bleeding increases with:

the use of medicines called steroid hormones (corticosteroids) and blood thinners (anticoagulants)
longer use
more frequent use
smoking
drinking alcohol
older age
having poor health.

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

Risk factors for heart disease include:

high blood pressure
high cholesterol levels
smoking
obesity
diabetes
family history of heart disease
female who has gone through menopause
male over age 40.

5. “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:

CELEXA® (citalopram HBr)
LEXAPRO® (escitalopram oxalate)
PAXIL® (paroxetine)
PROZAC®/SARAFEM® (fluoxetine)
SYMBYAX® (olanzapine/fluoxetine)
ZOLOFT® (sertraline)
LUVOX® (fluvoxamine).

Commonly used SNRIs are:

CYMBALTA® (duloxetine)
EFFEXOR® (venlafaxine).
 
Call your healthcare provider if you have symptoms of serotonin syndrome, which include:
mental changes (hallucinations, agitation, coma)
fast heartbeat
changes in blood pressure
high body temperature or sweating
tight muscles
trouble walking
nausea, vomiting, diarrhea.

6. TREXIMET should only be used:

exactly as prescribed
at the lowest dose possible for your treatment
for the shortest time needed.

7. 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?

Take 1 TREXIMET tablet to treat your migraine headache. Do not take more than 2 TREXIMET tablets in 24 hours. Doses should be separated by at least 2 hours.
TREXIMET can be taken with or without food.
Do not split, crush, or chew TREXIMET tablets.
If you take too much TREXIMET, call the Poison Control Center at 1-800-222-1222.

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:

uncontrolled high blood pressure
hemiplegic or basilar migraine. (Ask your doctor if you are not sure what type of migraine you have.)
liver problems
an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine
a heart attack or a history or symptoms of heart disease (such as chest pain or angina)
a stroke, mini-stroke (transient ischemic attack or TIA), or other stroke-like syndrome
problems with blood circulation to parts of your body, such as less blood flow to your intestines (ischemic bowel disease)
allergic reactions to sumatriptan, naproxen, or other ingredients in TREXIMET.

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:

ergotamine-containing medicine or
another triptan medicine.

Before starting TREXIMET, tell your healthcare provider about:

all of your medical conditions including kidney or liver problems
all allergies to any medicines
chest pain, shortness of breath, irregular heartbeats
medicines you may take for migraines, depression, or other health problems such as MAO inhibitors, SSRIs, or SNRIs
all the prescription and non-prescription medicines you take, including vitamins and herbal supplements. Some medicines can interact with TREXIMET and cause serious side effects.

Keep a list of your medicines to show to your healthcare provider. Before starting TREXIMET, tell your healthcare provider if you:

are pregnant, think you might be pregnant, or are trying to become pregnant. TREXIMET should not be used by pregnant women late in their pregnancy.
are breastfeeding
have a headache that is different from your usual migraine
have or have had epilepsy or seizures.

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:

shortness of breath or trouble breathing
chest pain
swelling of the face or throat
weakness in one part or on one side of your body
slurred speech.

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

nausea that seems out of proportion to your migraine
stomach pain
sudden/severe pain in your belly
vomit blood
blood in your bowel movement or it is black and sticky like tar
itching
skin rash or blisters with fever
yellow skin or eyes
swelling of the arms and legs, hands, feet, face, lips, or tongue
unusual weight gain
more tired or weaker than usual
flu-like symptoms
serotonin syndrome. See list of symptoms in “What is the most important information I should know about TREXIMET?”

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 to FDA at 1-800-FDA-1088.

How should I store TREXIMET?

Store TREXIMET at room temperature, 59° to 86°F (15° to 30°C).
Keep TREXIMET and all medicines out of the reach of children.

General information about TREXIMET

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use TREXIMET for a condition for which it was not prescribed.
Do not give TREXIMET to other people, even if they have the same problem you have. It may harm them.
This Medication Guide contains the most important information about TREXIMET. If you would like more information, talk with your healthcare provider.
You can ask your healthcare provider for information written for healthcare professionals.
For more information call 1-888-825-5249 (toll-free), or visit www.TREXIMET.com.

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.

TREXIMET, 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

©2012, GlaxoSmithKline. All rights reserved.

March 2012

TRX:4MG

Revised: 11/2012
 
GlaxoSmithKline LLC