TraMADol Hydrochloride ER (Eqv-Ultram ER)

TraMADol Hydrochloride ER (Eqv-Ultram ER) is used to treat moderate to severe pain.

The extended-release version of TraMADol Hydrochloride ER (Eqv-Ultram ER) is for continuous treatment of severe pain and should be taken daily. This version of TraMADol Hydrochloride ER (Eqv-Ultram ER) is not meant to be used as needed.

TraMADol Hydrochloride ER (Eqv-Ultram ER) may also be used for other reasons not mentioned in this medication guide.

Follow the directions on your prescription label and read all medication guides or instruction sheets. Never use TraMADol Hydrochloride ER (Eqv-Ultram ER) in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to use more of TraMADol Hydrochloride ER (Eqv-Ultram ER).

Never share TraMADol Hydrochloride ER (Eqv-Ultram ER) with another person, especially someone with a history of drug addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine where others cannot get to it. Selling or giving away this medicine is against the law.

Do not change your dose or stop using TraMADol Hydrochloride ER (Eqv-Ultram ER) without your doctor's advice. Ask a doctor before using any other opioid medications to treat or manage pain.

TraMADol Hydrochloride ER (Eqv-Ultram ER) can be taken with or without food, but take it the same way each time.

Swallow the capsule or tablet whole to avoid exposure to a potentially fatal overdose. Do not crush, chew, break, open, or dissolve.

Measure liquid medicine with the supplied measuring device (not a kitchen spoon).

Never crush or break a TraMADol Hydrochloride ER (Eqv-Ultram ER) pill to inhale the powder or mix it into a liquid to inject the drug into your vein. This practice has resulted in death.

You may have withdrawal symptoms if you stop using TraMADol Hydrochloride ER (Eqv-Ultram ER) suddenly. Ask your doctor before stopping the medicine.

Store at room temperature away from moisture and heat. Keep your medicine in a place where no one can use it improperly.

Do not keep leftover medicine. Just one dose can cause death in someone using it accidentally or improperly. Ask your pharmacist about a drug take-back program. You may also mix the leftover medicine with cat litter or coffee grounds in a sealed plastic bag and throw the bag in the trash.

MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep TraMADol Hydrochloride ER (Eqv-Ultram ER) where others cannot get to it.

Fatal side effects may occur if you also use alcohol or other drugs that cause drowsiness or slow breathing.

You should not take TraMADol Hydrochloride ER (Eqv-Ultram ER) if you are allergic to it, or if you have:

• severe asthma or breathing problems, a stomach or bowel obstruction (including paralytic ileus);
• if you have recently used alcohol, sedatives, tranquilizers, or narcotic medications; or
• if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, or tranylcypromine.

TraMADol Hydrochloride ER (Eqv-Ultram ER) should not be given to a child younger than 12 years old. Ultram ER should not be given to anyone younger than 18 years old. Do not give TraMADol Hydrochloride ER (Eqv-Ultram ER) to anyone between 12 and 18 years old who has a risk of breathing problems such as obstructive sleep apnea, obesity, or lung problems.

Do not give TraMADol Hydrochloride ER (Eqv-Ultram ER) to anyone younger than 18 years old who recently had surgery to remove the tonsils or adenoids.

Seizures have occurred in some people taking TraMADol Hydrochloride ER (Eqv-Ultram ER). Your risk of having a seizure may be higher if you have ever had:

• depression, a mental illness, head injury, epilepsy or other seizure disorder;
• an opioid overdose, or a drug or alcohol addiction; or
• a metabolic disorder.

Tell your doctor if you have or have ever had:

• urination, gallbladder, pancreas, or thyroid problems;
• a stomach disorder;
• breathing problems, sleep apnea, mental illness, or a suicide attempt; or
• liver or kidney disease.

May harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. If you use TraMADol Hydrochloride ER (Eqv-Ultram ER) during pregnancy, your baby could be born with life-threatening withdrawal symptoms and may need medical treatment for several weeks.

Do not breastfeed. TraMADol Hydrochloride ER (Eqv-Ultram ER) in breast milk can cause life-threatening side effects in a nursing baby.

Long-term use of TraMADol Hydrochloride ER (Eqv-Ultram ER) may affect fertility in men or women. Pregnancy could be harder to achieve while either parent is using this medicine.

Get emergency medical help if you notice signs of an allergic reaction (hives, trouble breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

TraMADol Hydrochloride ER (Eqv-Ultram ER) can slow or stop your breathing, which can lead to death, especially if you drink alcohol or use other drugs that cause drowsiness or slow breathing. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

TraMADol Hydrochloride ER (Eqv-Ultram ER) may cause serious side effects. Call your doctor right away if you have:

• headache, hunger, weakness, sweating, irritability, dizziness, fast heart rate, or feeling jittery;
• increased sensitivity to pain or if your pain gets worse;
• seizure (convulsions), confusion, problems with thinking or memory, weakness, feeling unsteady;
• noisy breathing, sighing, shallow breathing, breathing that stops during sleep, a slow heart rate or weak pulse, a light-headed feeling, like you might pass out; or
• low cortisol levels--nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Serious breathing problems may be more likely in older adults and people who are weak or have wasting syndrome or chronic breathing disorders.

Seek medical attention immediately if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common side effects of TraMADol Hydrochloride ER (Eqv-Ultram ER) may include:

• itching, constipation, nausea, vomiting, stomach pain; or
• dizziness, drowsiness, tiredness, headache.

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 the FDA at 1-800-FDA-1088.

Since TraMADol Hydrochloride ER (Eqv-Ultram ER) is used for pain, you are unlikely to miss a dose. If you do miss a dose and it is almost time for your next dose, skip the missed dose. Do not take two doses at the same time.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222. An overdose can be fatal, especially in a child or anyone using TraMADol Hydrochloride ER (Eqv-Ultram ER) without a prescription. Symptoms of an overdose may include severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

Your doctor may suggest that you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or do not wake up. Your caregiver must still call for emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.

Anyone can obtain naloxone from a pharmacy or local health department. Make sure that anyone caring for you knows where you keep naloxone and how to use it.

Do not drink alcohol or any products that contain alcohol. Dangerous side effects or death could happen.

Avoid driving or engaging in hazardous activities until you know how this medicine will affect you. Dizziness or drowsiness can lead to falls, accidents, or serious injuries. Also, avoid getting up too quickly from a sitting or lying position, or you may feel dizzy.

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Many other drugs can be dangerous when used with TraMADol Hydrochloride ER (Eqv-Ultram ER). Tell your doctor if you also use:

• medicine for allergies, asthma, blood pressure, motion sickness, irritable bowel, or overactive bladder;
• a benzodiazepine sedative like Valium, Klonopin, or Xanax;
• other opioid medicines, sleep medicine, muscle relaxers, or other drugs that make you drowsy; or
• drugs that affect serotonin, such as antidepressants, stimulants, or medicine for migraines or Parkinson's disease.

This list is not complete. Many other drugs may affect TraMADol Hydrochloride ER (Eqv-Ultram ER). This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.