TRAMADOL HYDROCHLORIDE- tramadol hydrochloride solution 
Palmetto Pharmaceuticals, Inc.

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Manufactured for: Palmetto Pharmaceuticals, Inc., Greenville, SC 29615
This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued/Revised: 09/2020

MEDICATION GUIDE
T
ramadol Hydrochloride Oral Solution, CIV

Tramadol hydrochloride oral solution is:

  • A strong prescription pain medicine that contains an opioid (narcotic) that is used for the management of 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 hydrochloride oral solution:

  • Get emergency help right away if you take too much tramadol hydrochloride oral solution (overdose). When you first start taking tramadol hydrochloride oral solution, 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 hydrochloride oral solution 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 hydrochloride oral solution. They could die from taking it. Selling or giving away tramadol hydrochloride oral solution is against the law.
  • Store tramadol hydrochloride oral solution securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

Important Information Guiding Use in Pediatric Patients:

  • Do not give tramadol hydrochloride oral solution to a child younger than 12 years of age.
  • Do not give tramadol hydrochloride oral solution to anyone younger than 18 years of age after surgery to remove the tonsils, adenoids, or both.
  • Avoid giving tramadol hydrochloride oral solution 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 tramadol hydrochloride oral solution 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 hydrochloride oral solution, 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 hydrochloride oral solution during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
  • breastfeeding. Not recommended; it may harm your baby.
  • taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking tramadol hydrochloride oral solution with certain other medicines can cause serious side effects that could lead to death.

When taking tramadol hydrochloride oral solution:

  • Do not change your dose. Take tramadol hydrochloride oral solution exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
  • Always use a calibrated oral syringe or other oral dosing device obtained from your doctor or pharmacist to
    correctly measure your dose. Never use a household teaspoon or tablespoon to measure tramadol hydrochloride oral solution.
  • Take your prescribed dose as indicated by your healthcare provider. The maximum dosage is 10 mL to 20 mL every 4 to 6 hours, as needed for pain relief. Do not take more than your prescribed dose and do not take more than 80 mL 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 hydrochloride oral solution regularly, do not stop taking tramadol hydrochloride oral solution without talking to your healthcare provider.
  • Dispose of expired, unwanted, or unused tramadol hydrochloride oral solution by taking your drug to an authorized Drug Enforcement
    Administration (DEA)-registered collector or drug take-back program. If one is not available, you can dispose of
    tramadol hydrochloride oral solution by mixing tramadol hydrochloride oral solution with dirt, cat litter, or used coffee grounds; placing the mixture in a container such as a sealed plastic bag; and throwing the container in the household trash.

While taking tramadol hydrochloride oral solution DO NOT:

  • Drive or operate heavy machinery, until you know how tramadol hydrochloride oral solution affects you. Tramadol hydrochloride oral solution 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 hydrochloride oral solution may cause you to overdose and die.

The possible side effects of tramadol hydrochloride oral solution:

  • 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 hydrochloride oral solution. 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.

Revised: 4/2022
Palmetto Pharmaceuticals, Inc.