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.
