product is used to treat moderate to moderately severe pain. It contains
2 medications: tramadol and acetaminophen. Tramadol is similar
to opioid (narcotic) analgesics. It works in the brain to
change how your body feels and responds to pain. Acetaminophen is
used to relieve pain and it can also reduce a fever.
Nausea vomiting constipation lightheadedness dizziness drowsiness
or sweating may occur. Some of these side effects may decrease after
you have been using this medication for a while. If any of these
effects persist or worsen tell your doctor or pharmacist promptly.
constipation eat dietary fiber drink enough water and exercise.
You may also need to take a laxative. Ask your pharmacist which type
of laxative is right for you.
reduce the risk of dizziness and lightheadedness get up slowly when
rising from a sitting or lying position.
that your doctor has prescribed this medication because he or she has judged
that the benefit to you is greater than the risk of side effects. Many people
using this medication do not have serious side effects.
your doctor right away if you have any serious side effects including:
mental/mood changes (such as agitation hallucinations) severe stomach/abdominal
pain difficulty urinating signs of your adrenal glands not
working well (such as loss of appetite unusual tiredness weight loss).
medical help right away if you have any very serious side effects including:
fast/irregular heartbeat severe dizziness fainting seizure.
medication may increase serotonin and rarely cause a very serious condition
called serotonin syndrome/toxicity. The risk increases if you are also
taking other drugs that increase serotonin so tell your doctor or pharmacist of
all the drugs you take (see Drug Interactions section). Get medical
help right away if you develop some of the following symptoms: fast
heartbeat hallucinations loss of coordination severe dizziness severe
nausea/vomiting/diarrhea twitching muscles unexplained fever unusual
changed into a strong opioid drug in your body. In some people this
change happens faster and more completely than usual which increases the risk
of very serious side effects. Get medical help right away if you notice any of
the following: slow/shallow breathing severe drowsiness/difficulty waking up
very serious allergic reaction to this drug is rare. However get
medical help right away if you notice any of the following symptoms: rash itching/swelling
(especially of the face/tongue/throat) severe dizziness trouble breathing.
is not a complete list of possible side effects. If you notice other effects
not listed above contact your doctor or pharmacist.
taking this product tell your doctor or pharmacist if you are
allergic to tramadol or acetaminophen; or if you have any
other allergies. This product may contain inactive ingredients which can
cause allergic reactions or other problems. Talk to your pharmacist for more
using this medication tell your doctor or pharmacist your medical
history especially of: brain disorders (such as head injury tumor seizures) breathing
problems (such as asthma sleep apnea chronic obstructive
pulmonary disease-COPD) kidney disease liver disease mental/mood
disorders (such as confusion depression suicidal thoughts)
personal or family history of a substance use disorder (such as
overuse of or addiction to drugs/alcohol) stomach/intestinal
problems (such as blockage constipation diarrhea due to
infection paralytic ileus) difficulty urinating (such as due to enlarged
prostate) gallbladder disease disease of the pancreas (pancreatitis) obesity.
drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis)
can make you more dizzy or drowsy. Do not drive use machinery or do anything
that needs alertness until you can do it safely. Avoid alcoholic beverages.
Talk to your doctor if you are using marijuana (cannabis).
cause a condition that affects the heart rhythm (QT prolongation). QT
prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat
and other symptoms (such as severe dizziness fainting) that need
medical attention right away.
risk of QT prolongation may be increased if you have certain medical conditions
or are taking other drugs that may cause QT prolongation. Before using
tramadol/acetaminophen tell your doctor or pharmacist of all the drugs you take
and if you have any of the following conditions: certain heart problems
(heart failure slow heartbeat QT prolongation in the EKG) family
history of certain heart problems (QT prolongation in the EKG sudden
levels of potassium or magnesium in the blood may
also increase your risk of QT prolongation. This risk may increase if you use
certain drugs (such as diuretics/"water pills") or if you have
conditions such as severe sweating diarrhea or vomiting.
Talk to your doctor about using tramadol/acetaminophen safely.
having surgery tell your doctor or dentist about all the products you
use (including prescription drugs nonprescription drugs and herbal
children may be more sensitive to very serious side effects of tramadol such as
extreme sleepiness confusion or slow/shallow/noisy breathing. (See also Warning
adults may be more sensitive to the side effects of this drug especially
confusion dizziness drowsiness slow/shallow breathing and QT prolongation (see
During pregnancy this
medication should be used only when clearly needed. It may harm an unborn baby.
Discuss the risks and benefits with your doctor. (See also Warning section.)
medication passes into breast milk and may have undesirable effects
on a nursing infant such as unusual sleepiness difficulty feeding
or trouble breathing. Breast-feeding while using this drug is not
recommended. Consult your doctor before breast-feeding.