Medication Guide

Tramadol Hydrochloride (TRAM-a-dol HYE-droe-KLOR-ide) and Acetaminophen (ass-eet-ah-MEE-noe-fen) Tablets, CIV

Tramadol hydrochloride and acetaminophen Tablet is:

• A strong prescription pain medicine that contains an opioid (narcotic) that is used for the short-term (five days or less) management of acute pain, 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 and acetaminophen tablet:

• Get emergency help right away if you take too much tramadol hydrochloride and acetaminophen tablet (overdose). When you first start taking tramadol hydrochloride and acetaminophentablet, 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.
• Tramadol hydrochloride and acetaminophen tabletcan cause severe drowsiness, breathing problems (respiratory depression), coma and death when taken with benzodiazepines or other medicines that depress consciousness.
• Never give anyone else your tramadol hydrochloride and acetaminophen tablet. They could die from taking it. Selling or giving away tramadol hydrochloride and acetaminophen tabletis against the law.
• Store tramadol hydrochloride and acetaminophen tablet securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.           
• Get emergency help right away if you take more than 4,000 mg of acetaminophen in 1 day. Taking tramadol hydrochloride and acetaminophen tablet with other products that contain acetaminophen can lead to serious liver problems and death.

Important Information Guiding Use in Pediatric Patients:

• Do not give tramadol hydrochloride and acetaminophen tablets to a child younger than 12 years of age.
• Do not give tramadol hydrochloride and acetaminophen tablets to a child younger than 18 years of age after surgery to remove the tonsils and/or adenoids.
• Avoid giving tramadol hydrochloride and acetaminophen tablets 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 taketramadol hydrochloride and acetaminophen tablet 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 any of its ingredients (e.g., tramadol hydrochloride or acetaminophen).
• Taken a Monoamine Oxidase Inhibitor, MAOI, (medicine used for depression) within the last 14 days.

Before taking tramadol hydrochloride and acetaminophen tablet, tell your healthcare provider if you have a history of:

Tell your healthcare provider if you are:

• pregnant or planning to become pregnant. Prolonged use of tramadol hydrochloride and acetaminophen tabletduring 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 and acetaminophen tabletwith certain other medicines can cause serious side effects that could lead to death.

When taking tramadol hydrochloride and acetaminophen tablet:

• Do not change your dose. Take tramadol hydrochloride and acetaminophen tabletexactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
• Take your prescribed dose: 2 tablets every 4 to 6 hours as needed for pain relief for a maximum of 5 days. 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 hydrochloride and acetaminophen tablet regularly, do not stop taking tramadol hydrochloride and acetaminophen tabletwithout talking to your healthcare provider.
• Dispose of expired, unwanted, or unused tramadol hydrochloride and acetaminophen tablet 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 and acetaminophen tablet by mixing the product with dirt, cat litter, or coffee grounds; placing the mixture in a sealed plastic bag and throwing the bag in your trash.

While taking tramadol hydrochloride and acetaminophen tabletDO NOT:

• Drive or operate heavy machinery, until you know how tramadol hydrochloride and acetaminophen tablet affects you. Tramadol hydrochloride and acetaminophen tablet 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 and acetaminophen tabletmay cause you to overdose and die.

The possible side effects of tramadol hydrochloride and acetaminophen tablet:

• 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 and acetaminophen tablet. 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 todailymed.nlm.nih.gov

Repackaged by:
Enovachem PHARMACEUTICALS
Torrance, CA 90501

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