Tramadol Hydrochloride and Acetaminophen Tablets – TERMATAJ-A

WHAT IS ACETAMINOPHEN AND TRAMADOL (TERMATAJ-A)?

Tramadol is a narcotic-like pain reliever. Acetaminophen is a less potent pain reliever that increases the effects of tramadol.

The combination of acetaminophen and tramadol is used to treat moderate to severe pain.

Acetaminophen and tramadol may also be used for purposes not listed in this medication guide.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF ACETAMINOPHEN AND TRAMADOL (TERMATAJ-A)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using acetaminophen and tramadol and call your doctor at once if you have any of these serious side effects:

  • seizure (convulsions);
  • agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting;
  • a red, blistering, peeling skin rash; or
  • shallow breathing, weak pulse.

Less serious side effects may include:

  • dizziness, drowsiness, weakness, tired feeling;
  • stomach pain, constipation, loss of appetite;
  • dry mouth, blurred vision;
  • feeling nervous or anxious;
  • sweating, itching; or
  • sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT ACETAMINOPHEN AND TRAMADOL (TERMATAJ-A)?

Tell your doctor if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen.

Do not take more of this medication than is recommended. An acetaminophen and tramadol overdose can damage your liver or cause death. The maximum amount of acetaminophen and tramadol is 2 tablets per dose, or 8 tablets per day.

You should not take this medication if you are allergic to acetaminophen and tramadol, if you are intoxicated (drunk), or if you have recently used narcotic pain medicine, a sedative or tranquilizer, medicine for depression or mental illness, or any type of street drug.

Do not drink alcohol while you are taking acetaminophen and tramadol. Alcohol may cause a dangerous decrease in your breathing when used together with acetaminophen and tramadol. Alcohol may also increase your risk of liver damage while taking acetaminophen.

Acetaminophen and tramadol may be habit-forming and should be used only by the person it was prescribed for. Never share this medication with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

WHAT SHOULD I DISCUSS WITH MY HEALTHCARE PROVIDER BEFORE TAKING ACETAMINOPHEN AND TRAMADOL (TERMATAJ-A)?

You should not take this medication if you are allergic to it, if you are intoxicated (drunk), or if you have recently used any of the following drugs:

  • alcohol;
  • tramadol (Ultram) or narcotic pain medicine;
  • sedatives or tranquilizers (such as Valium);
  • medicine for depression or anxiety;
  • medicine for mental illness (such as bipolar disorder, schizophrenia); or
  • street drugs.

Tell your doctor if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen.

Seizures have occurred in some people taking acetaminophen and tramadol. Your risk of a seizure may be higher if you have any of these conditions:

  • a history of drug or alcohol addiction;
  • a history of epilepsy or other seizure disorder;
  • a history of head injury;
  • a metabolic disorder;
  • an infection of your brain or spinal cord, such as meningitis or encephalitis;
  • if you are also taking an antidepressant, mood stabilizer, or another narcotic pain medicine; or
  • if you have taken an MAO inhibitor such as isocarboxazid (Marplan), linezolid (Zyvox), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days.

Talk with your doctor about your individual risk of having a seizure.

To make sure you can safely take acetaminophen and tramadol, tell your doctor if you have any of these other conditions:

  • kidney disease;
  • liver disease;
  • asthma or other breathing disorder;
  • a stomach disorder; or
  • a history of depression, mental illness, or suicide attempt.

Acetaminophen and tramadol may be habit-forming and should be used only by the person it was prescribed for. Never share this medication with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

FDA pregnancy category C. It is not known whether the combination of acetaminophen and tramadol is harmful to an unborn baby. Tramadol alone may have caused serious or fatal side effects in newborns of mothers who used the medication during pregnancy or labor. Tell your doctor if you are pregnant or plan to become pregnant during treatment with acetaminophen and tramadol.

Acetaminophen and tramadol can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

HOW SHOULD I TAKE ACETAMINOPHEN AND TRAMADOL (TERMATAJ-A)?

Take exactly as prescribed by your doctor. Do not take more of this medication than is recommended. An overdose of acetaminophen and tramadol can damage your liver or cause death. Follow the directions on your prescription label.

The maximum amount of acetaminophen and tramadol is 2 tablets per dose, or 8 tablets per day. Acetaminophen and tramadol should not be used for longer than 5 days in a row.

Acetaminophen and tramadol can be taken with or without food, but take it the same way each time.

Do not stop using this medicine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using acetaminophen and tramadol.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Acetaminophen and tramadol is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

WHAT HAPPENS IF I MISS A DOSE (TERMATAJ-A)?

Since pain medicine is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

WHAT HAPPENS IF I OVERDOSE (TERMATAJ-A)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An acetaminophen and tramadol overdose can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include drowsiness, shallow breathing, slow heartbeat, extreme weakness, sweating, cold or clammy skin, feeling light-headed, fainting, seizure, or coma.

WHAT SHOULD I AVOID WHILE TAKING ACETAMINOPHEN AND TRAMADOL (TERMATAJ-A)?

Do not drink alcohol while you are taking acetaminophen and tramadol. Alcohol may cause a dangerous decrease in your breathing when used together with acetaminophen and tramadol. Alcohol may also increase your risk of liver damage while taking acetaminophen.

Acetaminophen and tramadol may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

WHAT OTHER DRUGS WILL AFFECT ACETAMINOPHEN AND TRAMADOL (TERMATAJ-A)?

Cold or allergy medicine, sedatives, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by tramadol. Tell your doctor if you regularly use any of these medicines, or any narcotic pain medicine.

The following drugs can interact with acetaminophen and tramadol. Tell your doctor if you are using any of these:

  • carbamazepine (Carbatrol, Equetro, Tegretol);
  • warfarin (Coumadin, Jantoven);
  • digoxin (Lanoxin, Lanoxicaps);
  • ketoconazole (Nizoral);
  • erythromycin (E-Mycin, E.E.S., Ery-Tab);
  • rifampin (Rifadin, Rimactane, Rifater);
  • quinidine (Quin-G);
  • St. John’s wort;
  • sumatriptan (Imitrex, Treximet) and other migraine headache medicines;
  • an antidepressant such as amitriptyline (Elavil), citalopram (Celexa), desipramine (Norpramin), fluoxetine (Prozac, Sarafem), imipramine (Tofranil), nortriptyline (Pamelor), paroxetine (Paxil), or sertraline (Zoloft); or
  • drugs to treat high blood pressure or a prostate disorder, such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), terazosin (Hytrin), tamsulosin (Flomax).

This list is not complete and other drugs may interact with acetaminophen and tramadol. Tell your doctor about all medications you use. This includes prescription, over the counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

WHERE CAN I GET MORE INFORMATION?

Your pharmacist can provide more information about acetaminophen and tramadol.

 

CAUTION:

REMEMBER, KEEP THIS AND ALL OTHER MEDICINES OUT OF THE REACH OF CHILDREN, NEVER SHARE YOUR MEDICINES WITH OTHERS, AND USE THIS MEDICATION ONLY FOR THE INDICATION PRESCRIBED.

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