Medication Guide

ULTRAM ER (uhl-tram)([tramadol hydrochloride extended-release tablets]), CIV

ULTRAM ER is:

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A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily around-the-clock, long-term treatment with an opioid, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them.

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A long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.

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Not for use to treat pain that is not around-the-clock.

Important information about ULTRAM ER:

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Get emergency help right away if you take too much ULTRAM ER (overdose). When you first start taking ULTRAM ER, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.

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Taking ULTRAM ER with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.

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Never give anyone else your ULTRAM ER. They could die from taking it. Store ULTRAM ER away from children and in a safe place to prevent stealing or abuse. Selling or giving away ULTRAM ER is against the law.

Important Information Guiding Use in Pediatric Patients:

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Do not give ULTRAM ER to a child younger than 12 years of age.

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Do not give ULTRAM ER to a child younger than 18 years of age after surgery to remove the tonsils and/or adenoids.

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Avoid giving ULTRAM ER to children between 12 to 18 years of age who have risk factors for breathing problems such as obstructive sleep apnea, obesity, or underlying lung problems.

Do not take ULTRAM ER if you have:

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severe asthma, trouble breathing, or other lung problems.

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a bowel blockage or have narrowing of the stomach or intestines.

Before taking ULTRAM ER, tell your healthcare provider if you have a history of:

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head injury, seizures

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problems urinating

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abuse of street or prescription drugs, alcohol addiction, or mental health problems.

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liver, kidney, thyroid problems

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pancreas or gallbladder problems

Tell your healthcare provider if you are:

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pregnant or planning to become pregnant. Prolonged use of ULTRAM ER during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.

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breastfeeding. Not recommended - it may harm your baby.

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taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking ULTRAM ER with certain other medicines can cause serious side effects that could lead to death.

When taking ULTRAM ER:

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Do not change your dose. Take ULTRAM ER exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.

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Take your prescribed dose once a day at the same time every day. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.

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Swallow ULTRAM ER whole. Do not cut, break, chew, crush, dissolve, snort, or inject ULTRAM ER because this may cause you to overdose and die.

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Call your healthcare provider if the dose you are taking does not control your pain.

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Do not stop taking ULTRAM ER without talking to your healthcare provider.

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After you stop taking ULTRAM ER, dispose the unused ULTRAM ER in accordance with the local state guidelines and/or regulations.

While taking ULTRAM ER DO NOT:

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Drive or operate heavy machinery, until you know how ULTRAM ER affects you. ULTRAM ER can make you sleepy, dizzy, or lightheaded.

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Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with ULTRAM ER may cause you to overdose and die.

The possible side effects of ULTRAM ER:

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constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain, seizure. Call your healthcare provider if you have any of these symptoms and they are severe.

Get emergency medical help if you have:

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trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.

These are not all the possible side effects of ULTRAM ER. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov or call1-800-321-4576.

Manufactured by: Valeant Pharmaceuticals International, Inc., Steinbach, MB, R5G 1Z7, Canada and Distributed by: Janssen Pharmaceuticals, Inc., Titusville, NJ 08560 www.valeant.com

This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: 08/2017

Update p/n