TRAMADOL HYDROCHLORIDE- tramadol hydrochloride tablet, coated 
NuCare Pharmaceuticals,Inc.

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Medication Guide

 

Tramadol (TRAM-a-dol) Hydrochloride Tablets, USP, CIV

Tramadol HCl tablets are:

  • A strong prescription pain medicine that contains an opioid (narcotic) that is used for the management pain in adults, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
  • An 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.

Important information about tramadol HCl tablets:

  • Get emergency help right away if you take too much tramadol HCl tablets (overdose). When you first start taking tramadol HCl tablets, 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.
  • Taking tramadol HCl tablets 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.
  • Never give anyone else your tramadol HCl tablets. They could die from taking it. Store tramadol HCl tablets away from children and in a safe place to prevent stealing or abuse. Selling or giving away tramadol HCl tablets is against the law.

Do not take tramadol HCl tablets if you have:

  • Severe asthma, trouble breathing, or other lung problems.
  • A bowel blockage or have narrowing of the stomach or intestines.
  • An allergy to tramadol.
  • Taken a Monoamine Oxidase Inhibitor, MAOI, (medicine used for depression) within the last 14 days.

Before taking tramadol HCl tablets, tell your healthcare provider if you have a history of:

  • head injury, seizures
  • problems urinating
  • abuse of street or prescription drugs, alcohol addiction, or mental health problems.
  • liver, kidney, thyroid problems
  • pancreas or gallbladder problems

Tell your healthcare provider if you are:

  • pregnant or planning to become pregnant. Prolonged use of tramadol HCl tablets during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
  • breastfeeding. Tramadol HCl passes into breast milk and may harm your baby.
  • taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking tramadol HCl tablets with certain other medicines can cause serious side effects that could lead to death.

When taking tramadol HCl tablets:

  • Do not change your dose. Take tramadol HCl tablets exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
  • Take your prescribed dose as indicated by your health care provider. The maximum dosage is 1 or 2 tablets every 4 to 6 hours, as needed for pain relief. Do not take more than your prescribed dose and do not take more than 8 tablets per day. If you miss a dose, take your next dose at your usual time.
  • Call your healthcare provider if the dose you are taking does not control your pain.
  • If you have been taking tramadol HCl tablets regularly, do not stop taking tramadol HCl tablets without talking to your healthcare provider.
  • After you stop taking tramadol HCl tablets, ask your pharmacist how to dispose of any unused tablets.

While taking tramadol HCl tablets DO NOT:

  • Drive or operate heavy machinery, until you know how tramadol HCl affects you. Tramadol HCl tablets can make you sleepy, dizzy, or lightheaded.
  • Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with tramadol HCl tablets may cause you to overdose and die.

The possible side effects of tramadol HCl tablets:

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

    Get emergency medical help if you have:

  • 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 tramadol HCl tablets. 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

Manufactured by:
Amneal Pharmaceuticals of NY LLC
Brookhaven, NY 11719

Distributed by:
Amneal Pharmaceuticals LLC
Glasgow, KY 42141

Rev. 03-2017-00

This Medication Guide has been approved by the U.S. Food and Drug Administration.                                                     

Revised: 9/2020
NuCare Pharmaceuticals,Inc.