Treating moderate to moderately severe pain.

Tramadol is an analgesic. It works in certain areas of the brain and nervous system to decrease pain.

Do NOT use Tramadol if:

• you are allergic to any ingredient in Tramadol
• you have severe diarrhea due to taking an antibiotic
• you are intoxicated with alcohol, other opioids or narcotics (eg, morphine, codeine), sedatives or sleeping medicines (eg, temazepam, zolpidem), or other medicines
• you are taking nefazodone, carbamazepine, or sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Tramadol :

Some medical conditions may interact with Tramadol. 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 are allergic to codeine, a codeine-related medicine (eg, hydrocodone, dihydrocodeine, oxycodone), morphine, or a morphine-related medicine (eg, hydromorphone)
• if you have a history of alcohol abuse, substance abuse, or suicidal thoughts or behaviors
• 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 stomach or intestinal problems, asthma or other lung or breathing problems, epilepsy, seizures, or chronic inflammation or ulceration of the bowels
• if you have had recent abdominal surgery
• if you have heart problems, liver problems (eg, hepatitis), kidney problems, thyroid problems, enlargement of the prostate gland, or urinary problems

Some MEDICINES MAY INTERACT with Tramadol. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Carbamazepine because it may decrease Tramadol 's effectiveness and increase the risk of seizures
• Certain medicines for mental or mood disorders (eg, olanzapine, haloperidol), cyclobenzaprine, isoniazid, other opioid pain medicine (eg, codeine, hydrocodone), phenothiazines (eg, promethazine), sleeping medicines (eg, zolpidem), sodium oxybate (GHB), tricyclic antidepressants (amitriptyline), or weight loss medicines (eg, phentermine) because side effects, including excessive drowsiness, trouble breathing, liver problems, or seizures, may be increased
• Furazolidone, monoamine oxidase (MAO) inhibitors (eg, phenelzine), nefazodone, selegiline, or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because they may cause serious and sometimes fatal reactions, including restlessness, fever, excessive sweating, confusion, twitching, and seizures
• Oral anticoagulants (eg, warfarin) because its side effects, including bleeding, may be increased by Tramadol
• Digoxin because the risk of side effects, including nausea, vomiting, or slow heartbeat, may be increased by Tramadol

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tramadol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Tramadol :

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

• Take Tramadol by mouth with or without food.
• If you miss a dose of Tramadol , 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.

Ask your health care provider any questions you may have about how to use Tramadol.

Important safety information:

• Tramadol may cause drowsiness and dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Tramadol 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 ; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Tramadol 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.
• Tell your doctor or dentist that you take Tramadol before you receive any medical or dental care, emergency care, or surgery.
• Use Tramadol with caution in the ELDERLY; they may be more sensitive to its effects.
• Tramadol 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 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 while you are pregnant. Tramadol is found in breast milk. Do not breast-feed while taking Tramadol.

When used for long periods of time or at high doses, Tramadol 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 stops working well. Do not take more than prescribed.

Some people who use Tramadol 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 , 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.

Possible side effects of Tramadol :

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; increased sweating; loss of appetite; nausea.

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); agitation; fainting; fever; incoordination; muscle stiffness or tremor; seizures.