The following information is a summary about Fioricet. It is not intended to replace a doctor's instructions.
WHAT IS
IT
Acetaminophen is a pain reliever and fever reducer.
Butalbital is in a class of drugs called barbiturates
that slow down your central nervous system (brain
and nerve impulses) causing relaxation. Caffeine
is believed to constrict dilated blood vessels
that may contribute to tension headaches. Together,
acetaminophen, butalbital, and caffeine are
used to relieve complex tension (muscle contraction)
headaches although precisely how it works is
unknown. Acetaminophen / butalbital / caffeine
may also be used for purposes other than those
listed in this medication guide.
NORMAL
DOSE
Take acetaminophen / butalbital / caffeine exactly
as directed by your doctor. If you do not understand
these directions, ask your pharmacist, nurse,
or doctor to explain them to you. Take each
dose with a full glass of water. Take acetaminophen
/ butalbital / caffeine with food or milk if
it upsets your stomach. Never take more acetaminophen
/ butalbital / caffeine than is prescribed for
you. If your pain is not being adequately treated,
talk to your doctor. Store acetaminophen / butalbital
/ caffeine at room temperature away from moisture
and heat.
MISSED
DOSE
Take the missed dose as soon as you remember.
Do not take a double dose of this medication.
Wait the prescribed amount of time before taking
your next dose.
OVER
DOSE
Seek emergency medical attention. Symptoms of
an acetaminophen / butalbital / caffeine overdose
include insomnia, restlessness, tremor, nausea,
vomiting, diarrhea, abdominal pain, sweating,
seizures, drowsiness, decreased breathing, dizziness
or fainting, confusion, an irregular heartbeat,
and coma.
SIDE
EFFECTS
If you experience any of the following serious
side effects, stop taking acetaminophen / butalbital
/ caffeine and seek emergency medical attention:
an allergic reaction (difficulty breathing;
closing of your throat; swelling of your lips,
tongue, or face; or hives)
slow, weak breathing
liver damage (yellowing of the skin or eyes,
nausea, abdominal pain or discomfort, unusual
bleeding or bruising, severe fatigue)
blood problems (easy or unusual bleeding
or bruising)
low blood sugar (fatigue, increased hunger
or thirst, dizziness, or fainting)
These side effects are very rare and are not
likely to occur during proper treatment with
acetaminophen and caffeine. If you experience
any unusual reactions, stop taking this medicine
and seek the advice of your doctor. Other, less
serious side effects may be more likely to occur.
Continue to take acetaminophen / butalbital
/ caffeine and talk to your doctor if you experience:
drowsiness
dizziness, confusion or lightheadedness
shortness of breath
dry mouth
nausea, vomiting, abdominal pain, or decreased
appetite
tiredness, leg pain, or muscle weakness
agitation, irritability, nervousness, anxiety
or excitability
rash or itching
feeling of intoxication
headache
constipation
Butalbital may be habit forming. Side effects
other than those listed here may also occur.
Talk to your doctor about any side effect that
seems unusual or that is especially bothersome
.
PRECAUTIONS
Use caution when driving, operating machinery,
or performing other hazardous activities. Butalbital
will cause drowsiness or dizziness. If you experience
drowsiness or dizziness, avoid these activities.
Avoid sleeping pills, antihistamines, sedatives,
and tranquilizers except under the supervision
of your doctor. These may also make you drowsy.
Avoid alcohol. Alcohol taken during therapy
with acetaminophen and butalbital can be very
damaging to your liver and can increase drowsiness
and dizziness. Check the acetaminophen content
of other over-the-counter and prescription products
while taking this medication. You should not
exceed 4 grams (4000 mg) of acetaminophen per
day. Avoid taking too much caffeine. Check the
caffeine content of other over-the-counter and
prescription products as well as beverages (coffee,
tea, and colas) while taking this medication
DRUG
INTERACTIONS
Do not take acetaminophen / butalbital / caffeine
if you have taken a monoamine oxidase inhibitor
(MAOI) such as isocarboxazid (Marplan), phenelzine
(Nardil), or tranylcypromine (Parnate) in the
last 14 days. Dangerous side effects could result.
Acetaminophen and butalbital may increase the
effects of other drugs that cause drowsiness,
including antidepressants, alcohol, antihistamines,
sedatives (used to treat insomnia), other pain
relievers, anxiety medicines, and muscle relaxants.
Tell your doctor about all medicines that you
are taking, and do not take any medicine unless
your doctor approves. Many other medicines contain
acetaminophen, especially over-the-counter pain,
fever, cold, and allergy medications. Too much
acetaminophen can be very dangerous. Drugs other
than those listed here may also interact with
acetaminophen / butalbital / caffeine. Talk
to your doctor and pharmacist before taking
any prescription or over-the-counter medicines.
NOTES
Use caution when driving, operating machinery,
or performing other hazardous activities. Butalbital
will cause drowsiness or dizziness. If you experience
drowsiness or dizziness, avoid these activities.
Avoid sleeping pills, antihistamines, sedatives,
and tranquilizers except under the supervision
of your doctor. These may also make you drowsy.
Avoid alcohol. Alcohol taken during therapy
with acetaminophen and butalbital can be very
damaging to your liver and can increase drowsiness
and dizziness. Check the acetaminophen content
of other over-the-counter and prescription products
while taking this medication. You should not
exceed 4 grams (4000 mg) of acetaminophen per
day. Never take more acetaminophen / butalbital
/ caffeine than is prescribed for you. If your
pain is not being adequately treated, talk to
your doctor.
