Tramadol/
Acetaminophen

Tramadol/Acetaminophen is used for:

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Short-term treatment (5 days or less) of pain.

Tramadol/Acetaminophen is an analgesic combination. It works in certain areas of the brain and nervous system to decrease pain. The combination may provide better pain relief than either medicine alone.

Do NOT use Tramadol/Acetaminophen if:

• you are allergic to any ingredient in Tramadol/Acetaminophen or to any other codeine-or morphine-related medicine (eg, codeine, oxycodone, hydrocodone, dihydrocodeine, hydromorphone)
• 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 or carbamazepine
• you have liver problems
• you are taking any other medicine containing tramadol or acetaminophen

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

Before using Tramadol/Acetaminophen :

Some medical conditions may interact with Tramadol/Acetaminophen . 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 a history of alcoholism or substance abuse, or if you consume more than 3 alcoholic drinks per day
• if you have considered or attempted suicide
• if you have or recently have had any head injury, brain injury or tumor, increased pressure in the brain, infection of the brain or nervous system, epilepsy, or seizures
• if you have asthma or other lung or breathing problems
• if you have or have a history of stomach or intestinal problems, chronic inflammation or ulceration of the bowel, or 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/Acetaminophen . Tell your health care provider if you are taking any other medicines, especially any of the following:

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

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tramadol/Acetaminophen 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/Acetaminophen :

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

• Take Tramadol/Acetaminophen by mouth with or without food.
• Do not use Tramadol/Acetaminophen for more than 5 days unless advised to do so by your doctor.
• Do not take more than 8 tablets per day. Do not take more than 4 tablets per day if you have kidney problems.
• If you miss a dose of Tramadol/Acetaminophen 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/Acetaminophen .

Important safety information:

• Tramadol/Acetaminophen may cause drowsiness and dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Tramadol/Acetaminophen 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/Acetaminophen ; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Tramadol/Acetaminophen may cause dizziness; alcohol, hot weather, exercise, or fever may increase this effect. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of this effect.
• Tell your doctor or dentist that you take Tramadol/Acetaminophen before you receive any medical or dental care, emergency care, or surgery.
• Tramadol/Acetaminophen has acetaminophen in it. Before you start any new medicine, check the label to see if it has acetaminophen in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• Talk to your doctor before you take Tramadol/Acetaminophen if you drink more than 3 drinks with alcohol per day. Tramadol/Acetaminophen may cause stomach bleeding. Your risk may be greater if you drink alcohol while you are using Tramadol/Acetaminophen .
• Use Tramadol/Acetaminophen with caution in the ELDERLY; they may be more sensitive to its effects.
• Tramadol/Acetaminophen should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Tramadol/Acetaminophen 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/Acetaminophen while you are pregnant. Tramadol/Acetaminophen is found in breast milk. Do not breast-feed while taking Tramadol/Acetaminophen .

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

Some people who use Tramadol/Acetaminophen 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/Acetaminophen , you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea and vomiting; pain; rigid muscles; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Tramadol/Acetaminophen :

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.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); severe seizures (convulsions).

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.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org), or emergency room immediately. Symptoms may include bluish skin; cold clammy skin; difficult or slow breathing; drowsiness leading to unresponsiveness or coma; excessive sweating; loss of function in the heart and lungs; nausea and vomiting; pinpoint pupils; seizure (convulsions); stomach or intestinal pain.

Store Tramadol/Acetaminophen at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tramadol/Acetaminophen out of the reach of children and away from pets.

General information:

• If you have any questions about Tramadol/Acetaminophen , please talk with your doctor, pharmacist, or other health care provider.
• Tramadol/Acetaminophen is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Tramadol/Acetaminophen . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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