Better Homes And Gardens 2008 12, page 202 read online

MFDICATION GUIDF

TREXIMET™

[trex'i-met]

Tablets

(sum atriptan and naproxen sodium )

W h a t is th e m ost im p o rta n t in fo rm a tio n I should kn o w abo u t TREXIMET?

TRFXIMFT, w h ich contains sum a trip ta n and naproxen sodium {a nonsteroidal

a n ti-in fla m m a to ry d rug (NSAID)l, m ay increase the chance o f a h eart attack o r stroke

th a t can lead to death. I his chance increases:

• with longer use of NSAID medicines

• in people w h o have heart disease.

N SAID -containing m edicines, such as TREXIMET, should never be used rig h t before

or a fte r a heart surgery called a coronary a rte ry bypass g ra ft (CABG).

N SAID -containing m edicines, such as TREXIMET, can cause ulcers and bleeding in the

stom ach and intestines a t any tim e d u rin g tre a tm e n t. Ulcers and bleeding:

• can happen w ith o u t w a rn in g sym ptom s

• may cause death.

The chance o f a person g e ttin g an ulcer or bleeding increases w ith :

• the use o f m edicines called steroid horm ones (corticosteroids) and blood

thinners (anticoagulants)

• longer use

• m ore fre q u e n t use

• sm oking

• d rin k in g alcohol

• older age

• having p oor health.

TREXIMET is n o t recom m ended fo r people w ith risk factors fo r heart disease unless a

heart exam is done and show s no problem s.

The risk factors fo r heart disease include:

• high blood pressure

• high cholesterol levels

• smoking

• obesity

• diabetes

• family history of heart disease

• fem ale w h o nas gone th ro u g h menopause

• m ale over age 40.

"S erotonin syndrom e" is a serious and life -th re a te n in g problem th a t m ay occur w ith

TREXIMET. especially if used w ith antidepressant m edicines called selective serotonin

reuptake in h ib ito rs (SSRls) o r selective n o repinephrine reuptake in h ib ito rs (SNRIs).

C om m only used SSRls are:

• CELEXA*’ (citalopram HBr)

• LEXAPRO* (escitaloprarn oxalate)

• PAXIL* (paroxetine)

• PROZAC"/SARAFEMx (fluoxetine)

• SYMBYAX' (olanzapine/fluoxetine)

• ZOLOFT'1

(sertraline)

• LUVOX* (fluvoxam ine).

C om m only used SNRIs are:

• CYMBALTA* (duloxetine)

• EFFEXOR" (venlafaxine).

Call yo u r healthcare provid e r if yo u have sym ptom s o f serotonin syndrom e,

w hich include:

• m ental changes (hallucinations, a g ita tio n , coma)

• fast heartbeat

• changes in b lo o d pressure

• high body tem perature or sw eating

• tig h t muscles

• tro u b le w a lkin g

• nausea, vom iting, diarrhea.

TREXIMET should o n ly be used:

• exactly as prescribed

• a t the low est dose possible fo r your tre a tm e n t

• for the shortest time needed.

Do not take TRFXIMFT if you have taken other migraine medicines in the last

hours such as:

• ergotamine-contaimng medicine or

• another triptun medicine.

Before starting TRFXIMFT. tell your healthcare provider about:

• all of your medical conditions including kidney or liver problems

• all allergies to any medicines

• (host pain, shortness of breath, irregular heartbeats

• medicines you may take for migraines, depression, or other health problems such as

MAO inhibitors. SSRls, 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:

Other side effects include:

• heart attack

• pain, tightness, or

• heartbeat problems

pressure in the chest.

• stroke

neck, and throat

• high blood pressure

• stomach pain

• heart failure from body swelling (fluid retention)

• constipation

• kidney problems including kidney failure

• diarrhea

• bleeding and ulcers in the stomach and intestine

• gas

• low red blood cells (anemia)

• heartburn

• life-threatening skin reactions

• nausea

• life-threatening allergic reactions

• vomiting

• liver problems including liver failure

• dizziness

• asthma attacks in people who have asthma

• loss of blood circulation to areas of your body

• drowsiness

• tiredness

• serotonin syndrome (See list of symptoms in

• weakness

"What is the most important information

should

know about TREXIMET?")

• 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.

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

medicines: sumatriptan and naproxen sodium (an

NSAID). This Medication Guide provides important information you need to know

before taking TREXIMET. It docs not take the place of talking with your healthcare

provider about your medical condition or your treatment.

How should I take TREXIMET?

• Take

TREXIMET tablet to treat your migraine headache. Do not take more than

TREXIMET tablets in

hours Doses should be separated by at least

hours.

• TREXIMET can be taken with or without food.

• Do not split, crush, or chew IKEXIMEI tablets.

• II you lake too much TREXIMET. tall the Poison Control Center at

800

222

1222

Who should not take TRFXIMFT?

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 ynur doctor if yon are not sure what type of

migraine you have.)

• liver problems

• an asthma attack, hives, oi 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 TRFXIMFT if yoit takp or havp taken an antidepressant medicine called a

monoamine oxidase (MAO) inhibitor within the last

weeks. Common MAO

inhibitors are isocarboxazid (MARPIAN4), phenelzine (NARDIL4), tranylcypromine

(PARNATE«), and selegiline (ELDEPRYL* EMSAM»). Ask your healthcare provider if

you are not sure if your medicine is an MAO inhibitor

Call your healthcare provider for medical advice about side effects. You may report

side effects at FDA at

800

-FDA-

1088

How should I store TREXIMET?

• Store TREXIMET at room temperature,

° to 86°E (

° to

°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

888

ZS-SZ

(toll-free), or visit www.IREXIMEI.com.

What are the ingredients in TREXIMET?

Active ingredients: sumatriptan succinate and naproxpn sodium

Inactive ingredients: croscarmellose sodium, dextrose monohydrate, dibasic calcium

phosphate. FD&C Blue No.

, lecithin, magnesium stearate, maltodextrin, microcrystallme

cellulose, povidone, sodium bicarbonate, sodium carboxymethylcellulose, tali, and

titanium dioxide

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

IREXIMEI is a trademark of GlaxoSmithKline. and PAXIL and PARNAIE are registered

trademarks ol 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

2008

July

2008

TRX

The GlaxoSmithKline Group of Companies

August

2008