MEDICATION
GUIDE
TREXIMET™
ftrex' 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:
•
w
ith 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.
U
lcers and bleeding:
•
can
happen w
ithout warning symptoms
•
may cause death.
The chance of a person getting an
ulcer or bleeding increases w
ith:
•
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 w
ith 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
•
fam
ily history of heart d
isease
•
female who has gone through menopause
•
male over age
40
.
"Serotonin syndrome" is a serious and
life-threatening problem
that may
occur w
ith TREXIMET, especially if used
w
ith 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:
•
ergotam
ine-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
•
bleed
ing
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 b
lood
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 follow
ing 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 follow
ing 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 w
ith 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 w
ith
other medicines to
lessen pain or fever w
ithout 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 w
ith 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 should be
separated by at least
2
hours.
•
TREXIMET can
be
taken w
ith or w
ithout food.
•
Do
not split, crush, or chew
TREXIMET tablets.
•
If you take too
much
TREXIMET, call the Po
ison
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 m
igraine. (Ask your doctor if you are not sure what
type of m
igraine you have.)
•
liver problems
•
an asthma attack, hives, or other allergic reaction w
ith 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 w
ith 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 monoam
ine oxidase (MAO) inhibitor w
ithin 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 w
ith 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
B
lue No.
2
, lecithin, magnesium
stearate, maltodextrin,
m
icrocrystalline cellulose, povidone, sodium
bicarbonate, sod
ium
carboxymethylcellulose, talc, and
titanium
dioxide.
This Med
ication
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 G
laxoSm
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
w
ith and do
not endorse GlaxoSm
ithKline or its products.
GlaxoSmithKline
G
laxoSm
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
