The
following information is a summary about
Esgic
Plus. It is not intended to replace a doctor's
instructions.
Esgic Plus USES
Esgic Plus will relieve a headache best if you take
it as soon as the headache begins. If you get warning
signs of a migraine, take Esgic Plus as soon as you
are sure that the migraine is coming. This may even
stop the headache pain from occurring. Lying down
in a quiet, dark room for a while after taking the
medicine also helps to relieve headaches. People
who get a lot of headaches may need to take a different
medicine to help prevent headaches. It is important
that you follow your doctor's directions about taking
the other medicine, even if your headaches continue
to occur. Headache-preventing medicines may take
several weeks to start working. Even after they do
start working, your headaches may not go away completely.
However, your headaches should occur less often,
and they should be less severe and easier to relieve
than before. This will reduce the amount of headache
relievers that you need. If you do not notice any
improvement after several weeks of headache-preventing
treatment, check with your doctor.
Esgic Plus DIRECTIONS
Butalbital and acetaminophen (byoo-TAL-bi-tal and
a-seat-a-MIN-oh-fen) combination is a pain reliever
and relaxant. It is used to treat tension headaches.
Butalbital belongs to the group of medicines called
barbiturates (bar-BI-tyoo-rates) . Barbiturates act
in the central nervous system (CNS) to produce their
effects. When you take butalbital for a long time,
your body may get used to it so that larger amounts
are needed to produce the same effects. This is called
tolerance to the medicine. Also, butalbital may become
habit-forming (causing mental or physical dependence)
when it is used for a long time or in large doses.
Physical dependence may lead to withdrawal side effects
when you stop taking the medicine. In patients who
get headaches, the first symptom of withdrawal may
be new (rebound) headaches. Some butalbital and acetaminophen
combinations also contain caffeine (KAF-een) . Caffeine
may help to relieve headaches. However, caffeine
can also cause physical dependence when it is used
for a long time. This may lead to withdrawal (rebound)
headaches when you stop taking it. Butalbital and
acetaminophen combination may also be used for other
kinds of headaches or other kinds of pain as determined
by your doctor. Butalbital and acetaminophen combinations
are available only with your doctor's prescription
in the following dosage forms: Oral Butalbital and
Acetaminophen Capsules (U.S.) Tablets (U.S.) Butalbital,
Acetaminophen, and Caffeine Capsules (U.S.) Tablets
(U.S.)
Esgic Plus SIDE EFFECTS
Check with your doctor immediately if any of the
following side effects occur, especially if several
of them occur together: Rare Bleeding or crusting
sores on lips; chest pain; fever with or without
chills; hive-like swellings (large) on eyelids, face,
lips, and/or tongue ; muscle cramps or pain; red,
thickened, or scaly skin; shortness of breath, troubled
breathing, tightness in chest, or wheezing; skin
rash, itching, or hives; sores, ulcers, or white
spots in mouth (painful); sore throat Symptoms of
overdose Anxiety, confusion, excitement, irritability,
nervousness, restlessness, or trouble in sleeping
(severe, especially with products containing caffeine)
; convulsions (seizures) (for products containing
caffeine); diarrhea, especially if occurring together
with increased sweating, loss of appetite, and stomach
cramps or pain; dizziness, lightheadedness, drowsiness,
or weakness, (severe) ; frequent urination (for products
containing caffeine) ; hallucinations (seeing, hearing,
or feeling things that are not there); increased
sensitivity to touch or pain (for products containing
caffeine); muscle trembling or twitching (for products
containing caffeine); nausea or vomiting, sometimes
with blood; ringing or other sounds in ears (for
products containing caffeine); seeing flashes of
``zig-zag'' lights (for products containing caffeine);
shortness of breath or unusually slow or troubled
breathing; slow, fast, or irregular heartbeat; slurred
speech; staggering; swelling, pain, or tenderness
in the upper abdomen or stomach area; unusual movements
of the eyes Also, check with your doctor as soon
as possible if any of the following side effects
occur: Less common Confusion (mild); mental depression
; unusual excitement (mild) Rare Bloody or black,
tarry stools; bloody urine; pinpoint red spots on
skin; swollen or painful glands; unusual bleeding
or bruising ; unusual tiredness or weakness (mild)
Other side effects may occur that usually do not
need medical attention. These side effects may go
away during treatment as your body adjusts to the
medicine. However, check with your doctor if any
of the following side effects continue or are bothersome:
More common Bloated or ``gassy'' feeling; dizziness
or lightheadedness (mild); drowsiness (mild); nausea,
vomiting, or stomach pain (occurring without other
symptoms of overdose) Other side effects not listed
above may also occur in some patients. If you notice
any other effects, check with your doctor.
Esgic Plus PRECAUTIONS
Tell your doctor your medical history, especially
of: kidney disease, liver disease, seizure disorder,
lung disease, history of drug or alcohol dependency,
any allergies you may have. Limit alcohol as it may
add to the dizziness or drowsiness effects caused
by Esgic Plus. Because this drug may make you dizzy/drowsy,
use caution performing tasks requiring alertness
such as driving. Caution is advised when using this
drug in the elderly because they may be more sensitive
to the effects of the drug. Esgic Plus should be
used only when clearly needed during pregnancy. Discuss
the risks and benefits with your doctor. Esgic Plus
is excreted into breast milk. Because the effects
on a nursing infant are not known, consult your doctor
before breast- feeding.
Esgic Plus DRUG INTERACTIONS
Tell your doctor of all prescription and nonprescription
meds you may use, especially of: carbamazepine, narcotic
pain relievers (e.g., codeine), drugs used to aid
sleep, antidepressants (e.g., SSRI-types such as
fluoxetine or fluvoxamine), MAO inhibitors (e.g.,
furazolidone, linezolid, phenelzine, procarbazine,
selegiline, tranylcypromine), psychiatric medicine
(e.g., nefazodone), "triptan"-type drugs, anti-anxiety
drugs (e.g., diazepam), sibutramine. Also, report
use of certain antihistamines (e.g., diphenhydramine)
which are also present in many cough-and-cold products.
Do not start or stop any medicine without doctor
or pharmacist approval.
Esgic Plus OVERDOSE
If overdose is suspected, contact your local poison
control center or emergency room immediately.
Esgic Plus NOTES
Do not share Esgic Plus with others. Medical examinations
including the nose are generally performed during
prolonged use of this product to check for side effects.
Inform all your doctors you use (or have used) Esgic
Plus.
MISSED DOSE
If you miss a dose, use Esgic Plus as soon as you
remember. If it is near the time of the next dose,
skip the missed dose and resume your usual dosing
schedule. Do not "double-up" the dose to catch up.
Esgic Plus STORAGE
Store Esgic Plus at room temperature between 36 and
77 degrees F (2 -25 degrees C) away from light and
moisture.
