TRAMADOL Tabs 50mg

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Tramadol

Generic Name: Tramadol (TRAM-a-dol)
Brand Name: Ultram

Tramadol is used for:

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 had a severe allergic reaction (rash; hives; itching; 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

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

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 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.

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

Important safety information:

• Tramadol may cause drowsiness or 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.
• 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 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. Your risk may be greater if you take Tramadol 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 with caution in the ELDERLY; they may be more sensitive to its effects, especially constipation, weakness or tiredness, severe lightheadedness, and indigestion.
• 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; dry mouth; headache; 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); 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.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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