Information
About Ultracet
Description
Combination medicines containing opioid analgesics (nar-KOT-ik
an-al-JEE-zicks ) such as tramadol (TRA-ma-dole) and acetaminophen
(a-seat-a-MIN-oh-fen ) are used to relieve pain. An opioid
analgesic and acetaminophen used together may provide better
pain relief than either medicine used alone. In some cases,
you may get relief with lower doses of each medicine.
Opioid analgesics act in the central nervous
system (CNS) to relieve pain. Many of their side effects
are also caused by actions in the CNS. When opioids are
used for a long time, your body may get used to them so
that larger amounts are needed to relieve pain. This is
called tolerance to the medicine. Also, when opioids are
used for a long time or in large doses, they may become
habit-forming (causing mental or physical dependence). Physical
dependence may lead to withdrawal symptoms when you stop
taking the medicine.
Acetaminophen does not become habit-forming
when taken for a long time but it may cause other unwanted
effects, when taken in large doses including liver damage,
if too much is taken.
This medicine is available only with your
doctor's prescription, in the following dosage form:
Oral
Tablets (U.S.)
Before Using This Medicine
In deciding to use a medicine, the risks of taking the medicine
must be weighed against the good it will do. This is a decision
you and your doctor will make. For tramadol and acetaminophen,
the following should be considered:
Allergies—Tell your doctor if you
have ever had any unusual or allergic reaction to tramadol,
other opioid analgesics or acetaminophen. Also tell your
health care professional if you are allergic to any other
substances, such as foods, preservatives, or dyes.
Pregnancy—Tramadol and acetaminophen
has not been studied in pregnant women. However, studies
in animals have shown that tramadol and acetaminophen causes
birth defects and other problems. Before taking this medicine,
make sure your doctor knows if you are pregnant or if you
may become pregnant.
Too much use of an opioid during pregnancy
may cause the fetus to become dependent on the medicine.
This may lead to withdrawal side effects in the newborn
baby. Newborn seizures, symptoms of withdrawal from opioids,
death of the fetus and still birth have been reported.
Breast-feeding—Tramadol and acetaminophen
pass into breast milk and may cause unwanted side effects
in nursing babies. It may be necessary for you to take another
medicine or to stop breast-feeding during treatment. Be
sure you have discussed the risks and benefits of the medicine
with your doctor.
Children—Studies on this medicine
have been done only in adult patients, and there is no specific
information comparing use of tramadol and acetaminophen
in children up to 16 years of age with use in other age
groups.
Older adults—This medicine has been
tested and has not been shown to cause different side effects
or problems in older people than it does in younger adults.
Other medicines—Although certain
medicines should not be used together at all, in other cases
two different medicines may be used together even if an
interaction might occur. In these cases, your doctor may
want to change the dose, or other precautions may be necessary.
When you are taking tramadol and acetaminophen, it is especially
important that your health care professional know if you
are taking any of the following:
Tramadol and acetaminophen
Anticoagulants (e.g., Coumadin [blood thinners])—Tramadol
and acetaminophen may increase the amount of blood thinners
in your blood, which can cause problems with bleeding.
Alcohol and products with alcohol in them—Taking these
medicines with tramadol and acetaminophen may cause problems
with your liver.
For acetaminophen:
Acetaminophen-containing products (e.g.,
Tylenol, Nyquil, Chlor-Trimeton Sinus)—Taking additional
acetaminophen may increase the risk of liver problems.
For tramadol:
Analgesics, opioid (e.g., codeine, morphine) or
Antidepressants such as tricyclic antidepressants (e.g.,
amitriptyline [Elavil], doxepin [Sinequan]), and selective
serotonin reuptake inhibitors (e.g., citalopram [Celexa],
fluvoxamine [Luvox], sertraline [Zoloft]), and medicines
with Monoamine oxidase (MAO) inhibitor activity (isocarboxazid
[e.g., Marplan], phenelzine [e.g., Nardil], procarbazine
[e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine
[e.g., Parnate]) or
Neuroleptics (e.g., Thorazine, Prolixin)—Taking these
medicines with tramadol may increase the possibility of
seizures or convulsions.
Alcohol and products with alcohol in them or
Anesthetic medicines or
Central nervous system (CNS) depressants such as , narcotic
pain relievers (e.g., Codeine, Darvon), phenothiazines (e.g.,
Thorazine, Prolixin), sedative hypnotics (e.g., Valium,
Xanax), tranquilizers (e.g., Ativan, Haldol—Taking
these medicines with tramadol may increase the chance of
serious side effects.
Carbamazepine (e.g., Tegretol)— May decrease the blood
levels of Tramadol, which increases the chance of serious
side effects
Monoamine oxidase (MAO) inhibitor activity (isocarboxazid
[e.g., Marplan], phenelzine [e.g., Nardil], procarbazine
[e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine
[e.g., Parnate]) (taken currently or within the past 2 weeks)—Taking
tramadol with these medicines may cause more of a chance
for seizures. It may also cause high blood pressure, unusual
heartbeats, or headache
Selective serotonin reuptake inhibitors (SSRI) (citalopram
[e.g., Celexa], fluvoxamine [e.g., Luvox], and sertraline
[e.g., Zoloft] —Taking these medicines with tramadol
and acetaminophen may increase the possibility of seizures
or convulsions
Other medical problems—The presence
of other medical problems may affect the use of tramadol
and acetaminophen. Make sure you tell your doctor if you
have any other medical problems, especially:
Alcohol and/or other drug abuse, or history of, or
Convulsions (seizures), history of, or
Head injury, or
Hormonal problems or
Infections of the central nervous system or
Kidney disease or
Liver disease, or
Respiratory difficulty or troubled breathing, or
Severe abdominal problems—The chance of serious side
effects may be increased
Proper Use of This Medicine
Take this medicine only as directed by your medical doctor
or dentist. Do not take more of it, do not take it more
often, and do not take it for a longer time than your medical
doctor or dentist ordered. This is especially important
for young children and elderly patients, who may be more
sensitive than other people to the effects of analgesics.
If too much of a analgesic is taken, it may become habit-forming
(causing mental or physical dependence) or lead to medical
problems because of an overdose. Taking too much acetaminophen
may cause liver damage.
Dosing—
The dose of tramadol and acetaminophen
will be different for different patients. Follow your doctor's
orders or the directions on the label. The following information
includes only the average doses of tramadol and acetaminophen.
If your dose is different, do not change it unless your
doctor tells you to do so.
The number of doses you take each day,
the time allowed between doses, and the length of time you
take the medicine depend on the medical problem for which
you are taking tramadol and acetaminophen
For oral dosage form (tablets):
For pain:
Adults and adolescents 16 years and older—Take 2 tablets
every 4–6 hours as needed for up to 5 days.
Children under 16 years of age–use and dose must be
determined by your doctor.
Storage—
To store this medicine:
Keep out of the reach of children. Overdose
of tramadol and acetaminophen is very dangerous in young
children.
Do not store in the bathroom, near the kitchen sink, or
in other damp places. heat or moisture may cause the medicine
to break down.
Do not keep outdated medicine or medicine no longer needed.
Ask your health care professional how you should dispose
of any medicine you do not use. Be sure that any discarded
medicine is out of the reach of children.
Precautions While Using This Medicine
The analgesic in this medicine will add to the effects of
alcohol and other CNS depressants (medicines that slow down
the nervous system, possibly causing drowsiness). Some examples
of CNS depressants are antihistamines or medicine for hay
fever, other allergies, or colds; sedatives, tranquilizers,
or sleeping medicine; other prescription pain medicine or
narcotics; opioids; barbiturates; medicine for seizures;
muscle relaxants; or anesthetics, including some dental
anesthetics. Also, there may be a greater risk of liver
damage if you drink three or more alcoholic beverages while
you are taking acetaminophen. Do not drink alcoholic beverages,
and check with your medical doctor or dentist before taking
any of the medicines listed above, while you are using this
medicine.
This medicine may cause some people to
become drowsy, dizzy, or less alert than they are normally.
Make sure you know how you react to this medicine before
you drive, use machines, or do anything else that could
be dangerous if you are dizzy or are not alert.
Dizziness, lightheadedness, or fainting
may occur, especially when you get up suddenly from a lying
or sitting position. Getting up slowly may help lessen this
problem.
Nausea or vomiting may occur, especially
after the first couple of doses. This effect may go away
if you lie down for a while. However, if nausea or vomiting
continues, check with your medical doctor or dentist. Lying
down for a while may also help relieve some other side effects,
such as dizziness or lightheadedness, that may occur.
Before having any kind of surgery (including
dental surgery) or emergency treatment, tell the medical
doctor or dentist in charge that you are taking this medicine.
Analgesics may cause dryness of the mouth.
For temporary relief, use sugarless candy or gum, melt bits
of ice in your mouth, or use a saliva substitute. However,
if dry mouth continues for more than 2 weeks, check with
your dentist. Continuing dryness of the mouth may increase
the chance of dental disease, including tooth decay, gum
disease, and fungus infections.
If you have been taking this medicine regularly
, do not suddenly stop taking it without first checking
with your doctor. Your doctor may want you to reduce gradually
the amount you are taking before stopping completely, to
lessen the chance of withdrawal side effects. This will
depend on which of these medicines you have been taking,
and the amount you have been taking every day.
Side Effects of This Medicine
Side Effects of This Medicine
Along with its needed effects, a medicine may cause some
unwanted effects. Although not all of these side effects
may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any
of the following side effects occur:
Rare
Burning, itching, and redness of skin; vomiting ; chest
pain; cough; difficulty swallowing; dizziness; fast heartbeat;
hives; itching; puffiness or swelling of the eyelids or
around the eyes, face, lips or tongue; shortness of breath;
skin rash; tightness in chest; unusual tiredness or weakness;
wheezing; seizures
Symptoms of Overdose
If you think you, or someone else may have taken an overdose,
get emergency help at once. Get emergency help immediately
if any of the following symptoms of overdose occur
Chest pain or discomfort; convulsions ;
difficulty breathing
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.
Less common
Abdominal pain; aches, pains or weakness of muscles; numbness
or tingling of hands, legs, and feet; acid or sour stomach;
belching; heartburn; indigestion; stomach discomfort ; anxiety;
bloated full feeling; excess air or gas in stomach or intestines;
confusion; constipation; dizziness; dry mouth; false or
unusual sense of well-being; feeling of warmth; redness
of the face, neck, arms, and occasionally the upper chest;
headache; increased sweating; increase in bowel movements;
loose stools; soft stools; itching skin; loss of appetite;
weight loss; loss of strength or energy; muscle pain or
weakness; mood or mental changes; nausea; nervousness; painful
or difficult urination; rash; sleepiness or unusual drowsiness;
sleeplessness; trouble sleeping; unable to sleep; unusual
tiredness or weakness; vomiting
Rare
Abnormal thinking; bloody or black, tarry stools; vomiting
of blood or material that looks like coffee grounds; sever
stomach pain; constipation; blurred vision; dizziness; severe
or continuing, dull headache; pounding in the ears; slow
or fast heartbeat; change in vision; chills; cold sweats;
confusion; dizziness; faintness, or light-headedness when
getting up from lying or sitting position; continuing ringing
or buzzing or other unexplained noise in ears; crying; depersonalization;
dysphoria; euphoria; mental depression; paranoia; quick
to react or overreact emotionally; rapidly changing moods
; decreased awareness or responsiveness; decrease in amount
of urine; decrease in urine volume; decrease in frequency
of urination; difficulty in passing urine [dribbling]; painful
urination; depression ; difficulty swallowing; dizziness
or lightheadedness; feeling of constant movement of self
or surroundings; sensation of spinning; drug abuse and dependence
; fainting; fast, pounding, or irregular heartbeat or pulse;
palpitations; feeling unusually cold; shivering ; high or
low blood pressure; dizziness; lightheadedness ; increased
muscle tone; involuntary muscle contractions; loss in sexual
ability, desire, drive, or performance; decreased interest
in sexual intercourse; inability to have or keep an erection;
loss of memory; problems with memory; loss of sense of reality;
morbid dreaming; migraine headache; seeing, hearing, or
feeling things that are not there; shakiness and unsteady
walk; clumsiness, unsteadiness, trembling, or other problems
with muscle control or coordination; shortness of breath;
difficult or labored breathing; tightness in chest; wheezing
; swelling of tongue; trouble in holding or releasing urine;
painful urination; unusual tiredness or weakness; weight
loss; yellow eyes or skin
After you stop using this medicine, your body may need time
to adjust. The length of time this takes depends on which
of these medicines you were taking, the amount of medicine
you were using, and how long you used it. During this time
check with your doctor if you notice any of the following
side effects:
Anxiety; diarrhea; fever, runny nose, or
sneezing ; gooseflesh; increased sweating; nausea or vomiting;
nervousness, restlessness, or irritability; pain ; seeing,
hearing, or feeling things that are not there; shivering
or trembling; trouble in sleeping
Other side effects not listed above may also occur in some
patients. If you notice any other effects, check with your
doctor.
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