Tramadol Extended-Release Tablets

Generic Name: Tramadol (TRAM-a-dol)

Tramadol Extended-Release Tablets are used for:

Treating moderate to moderately severe chronic pain in
certain patients.

Tramadol Extended-Release Tablets are an analgesic. It works
in certain areas of the brain and nervous system to decrease pain

Do NOT use Tramadol Extended-Release Tablets if:

• you are allergic
  to any ingredient in Tramadol Extended-Release Tablets

• you have had a severe allergic
  reaction (rash; hives; difficulty breathing; tightness in the chest;
  swelling of the mouth, face, lips, or tongue) to codeine or other opioids (eg,
  morphine)

• you are intoxicated with alcohol,
  other opioids or narcotics (eg, codeine, morphine), sedatives or sleeping
  medicines (eg, temazepam, zolpidem), or other medicines

• you have severe liver or kidney
  problems

• you are taking carbamazepine,
  nefazodone, sodium oxybate (GHB), a thioxanthene (eg, thiothixene), or
  another product that contains tramadol

Before using Tramadol Extended-Release Tablets:

Some medical conditions may interact with Tramadol
Extended-Release Tablets. Tell your doctor or pharmacist if you have any medical
conditions, especially if any of the following apply to you:

• if you are pregnant, planning to
  become pregnant, or are breast-feeding

• if you are taking any
  prescription (especially depression medicines) or nonprescription medicine,
  herbal preparation, or dietary supplement

• if you have allergies to
  medicines, foods,
  or other substances

• if you have liver, kidney, or
  thyroid problems; a blockage in the bladder; diabetes; heart
  problems; high blood pressure; prostate problems; or metabolism
  problems

• if you have or recently have had
  any head injury, brain injury or tumor, increased pressure in the brain, or
  infection of the brain or nervous system

• if you have a history of diarrhea
  caused by antibiotic use, recent stomach or bowel surgery, or any other
  stomach or bowel
  problems (eg, pain, inflammation, ulcers)

• if you have a history of lung or
  breathing problems (eg, asthma, chronic obstructive pulmonary disease [COPD])
  or a seizure disorder (eg, epilepsy)

• if you are going through
  withdrawal from alcohol or other substances or if you have a history of
  alcohol or other substance abuse, mood or mental problems (eg, depression),
  or suicidal thoughts or actions

How to use Tramadol Extended-Release Tablets:

Use Tramadol Extended-Release Tablets as directed by your
doctor. Check the label on the medicine for exact dosing instructions.

• Take Tramadol Extended-Release
  Tablets by mouth with or without food.
  Try to take it the same way (either with food or without food) each time you
  take your dose. Check with your doctor or pharmacist if you have questions
  about taking Tramadol Extended-Release Tablets with food.

• Swallow Tramadol Extended-Release
  Tablets whole. Do not break, crush, or chew before swallowing.

• If you miss a dose of Tramadol
  Extended-Release Tablets and you are taking it regularly, take it as soon as
  possible. If it is almost time for your next dose, skip the missed dose and
  go back to your regular dosing schedule. Do not take 2 doses at once.

Important safety information:

• Tramadol Extended-Release Tablets
  may cause drowsiness, dizziness, or blurred vision. These effects may be
  worse if you take it with alcohol or certain medicines. Use Tramadol
  Extended-Release Tablets with caution. Do not drive or perform other
  possibly unsafe tasks until you know how you react to it.

• Do not drink alcohol or use
  medicines that may cause drowsiness (eg, sleep
  aids, muscle relaxers) while you are using Tramadol
  Extended-Release Tablets; it may add to their effects. Ask your pharmacist
  if you have questions about which medicines may cause drowsiness.

• Tramadol Extended-Release Tablets
  may cause dizziness; alcohol, hot weather, exercise, or fever may increase
  this effect. To prevent it, sit up or stand slowly, especially in the
  morning. Sit or lie down at the first sign of this effect.

• Do NOT take more than the
  recommended dose or use for longer than prescribed without checking with
  your doctor.

• Tell your doctor or dentist that
  you take Tramadol Extended-Release Tablets before you receive any medical or
  dental
  care, emergency care, or surgery.

• Serotonin syndrome is a possibly
  fatal syndrome that can be caused by Tramadol Extended-Release Tablets. Your
  risk may be greater if you take Tramadol Extended-Release Tablets with
  certain other medicines (eg, “triptans,” MAOIs). Symptoms may
  include agitation; confusion; hallucinations; coma; fever; fast or irregular
  heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea.
  Contact your doctor at once if you have any of these symptoms.

• Use Tramadol Extended-Release
  Tablets with caution in the ELDERLY; they may be more sensitive to its
  effects, especially constipation,
  weakness or tiredness, severe lightheadedness, and indigestion.

• Tramadol Extended-Release Tablets
  should not be used in CHILDREN
  younger than 16 years old; safety and effectiveness in these children have
  not been confirmed.

• PREGNANCY and BREAST-FEEDING:
  Tramadol Extended-Release Tablets has been shown to cause harm to the fetus.
  If you think you may be pregnant, contact your doctor. You will need to
  discuss the benefits and risks of using Tramadol Extended-Release Tablets
  while you are pregnant. Tramadol Extended-Release Tablets are found in
  breast milk. Do not breast-feed while taking Tramadol Extended-Release
  Tablets.

When used for long periods of time or at high doses, Tramadol
Extended-Release Tablets may not work as well and may require higher doses to
obtain the same effect as when originally taken. This is known as TOLERANCE.
Talk with your doctor if Tramadol Extended-Release Tablets stops working well.
Do not take more than prescribed.

Some people who use Tramadol Extended-Release Tablets for a
long time without a break may develop a physical need to continue taking it.
This is known as physical DEPENDENCE. If you suddenly stop taking Tramadol
Extended-Release Tablets, you may experience WITHDRAWAL symptoms, including
anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin
sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing,
hearing or feeling things that are not there; shivering or tremors; sweating;
and trouble
sleeping. Do not suddenly stop taking Tramadol Extended-Release
Tablets without talking with your doctor. If you need to stop Tramadol
Extended-Release Tablets, your doctor will lower your dose over time.

Possible side effects of Tramadol Extended-Release Tablets:

All medicines may cause side effects, but many people have
no, or minor, side effects. Check with your doctor if any
of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; dry mouth;
headache; increased sweating; nausea; trouble sleeping; vomiting; weakness.

Seek medical attention right away if any of these SEVERE
side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty
breathing; tightness in the chest; swelling of the mouth, face, lips, or
tongue; unusual hoarseness); agitation; chest pain; difficult or painful
urination; disorientation; fainting; hallucinations; irregular heartbeat; loss
of coordination; mood or mental changes (eg, depression); red, blistered,
swollen, or peeling skin;
seizures; severe dizziness or lightheadedness.