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:
•
with longer use of NSAID medicines
•
in people who have heart disease.
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:
•
can happen without warning symptoms
•
may cause death.
The chance of a person 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.
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:
•
high blood pressure
•
high cholesterol levels
•
smoking
•
obesity
•
diabetes
•
family history of heart disease
•
female who has gone through menopause
•
male over age
40
.
"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® (fluvoxam
ine).
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, vom
iting, diarrhea.
Do not take TREXIMET if you have taken other m
igraine 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 m
igraines, depression, or other health
problems such as MAO inhibitors, SSRIs, or SNRIs
•
all the prescription and non-prescription medicines you take, including
vitam
ins and herbal supplements. Some medicines can interact w
ith
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 m
ight 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 m
igraine
•
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
•
constipation
(fluid retention)
•
diarrhea
•
kidney problems including kidney failure
•
gas
•
bleeding and ulcers in the stomach and intestine
•
heartburn
•
low red blood cells (anem
ia)
•
nausea
•
life-threatening skin reactions
•
vom
iting
•
life-threatening allergic reactions
•
dizziness
•
liver problems including liver failure
•
drowsiness
•
asthma attacks in people who have asthma
•
tiredness
•
loss of blood circulation to areas of your body
•
weakness
•
serotonin syndrome (See list of symptoms
•
tingling and numbness
in "What is the most important information
•
unusual body sensations
I should know about TREXIMET?")
•
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 m
igraine
•
stomach pain
•
sudden/severe pain in your belly
•
vom
it 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?"
TREXIMET should only be used:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
for the shortest time needed.
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 m
igraine attacks in adults.
It does not prevent or lessen the number of m
igraines 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 m
igraine headache. Do not take more than
2
TREXIMET tablets in
24
hours. Doses snould 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
•
hem
iplegic 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, m
ini-stroke (transient ischem
ic 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 (ischem
ic 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®), tranylcyprom
ine (PARNATE®), and selegiline (ELDEPRYL®
EMSAM®). Ask your healthcare provider if you are not sure if your medicine
is an MAO inhibitor.
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?
•
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,
m
icrocrystalline cellulose, povidone, sodium
bicarbonate, sodium
carboxymethylcellulose, talc, and titanium
dioxide.
This Medication Guide has been approved by the U.S. Food and Drug
Adm
inistration.
TREXIMET is a trademark of GlaxoSm
ithKline, and PAXIL and PARNATE are
registered trademarks of GlaxoSm
ithKline.
The other brands listed are trademarks of their respective owners and are not
trademarks of GlaxoSm
ithKline. The makers of these brands are not affiliated
with and do not endorse GlaxoSm
ithKline or its products.
GlaxoSmithKline
GlaxoSm
ithKline
Research Triangle Park, NC
27709
©
2008
, GlaxoSm
ithKline. All rights reserved.
July
2008
TRX:
2
MG
©2009
The GlaxoSm
ithKline Group of Companies
All rights reserved. Printed in USA. TMC
256
R
0
April
2009
