TRAMADOL HYDROCHLORIDE- tramadol hydrochloride tablet, film coated 
Zydus Pharmaceuticals (USA) Inc.

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MEDICATION GUIDE

Tramadol hydrochloride (tram' a dol hye" droe klor' ide) Tablets, USP, CIV

Tramadol hydrochloride tablets are:

Important information about tramadol hydrochloride tablets:

Important Information Guiding Use in Pediatric Patients:

Taken a Monoamine Oxidase Inhibitor, MAOI, (medicine used for depression) within the last 14 days.

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

Tell your healthcare provider if you are:

When taking tramadol hydrochloride tablets:

Do not change your dose. Take tramadol hydrochloride 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 healthcare 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 hydrochloride tablets regularly, do not stop taking tramadol hydrochloride tablets without talking to your healthcare provider. After you stop taking tramadol hydrochloride tablets, ask your pharmacist how to dispose of any unused tablets.

While taking tramadol hydrochloride tablets DO NOT:

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

The possible side effects of tramadol hydrochloride tablets:

Get emergency medical help if you have:

Health care professionals should not abruptly discontinue opioids in a patient who is physically dependent. When you and your patient have agreed to taper the dose of opioid analgesic, consider a variety of factors, including the dose of the drug, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient. No standard opioid tapering schedule exists that is suitable for all patients. Create a patient-specific plan to gradually taper the dose of the opioid and ensure ongoing monitoring and support, as needed, to avoid serious withdrawal symptoms, worsening of the patient's pain, or psychological distress (For tapering and additional recommendations, see Additional Information for Health Care Professionals).

Patients taking opioid pain medicines long-term should not suddenly stop taking your medicine without first discussing with your health care professional a plan for how to slowly decrease the dose of the opioid and continue to manage your pain. Even when the opioid dose is decreased gradually, you may experience symptoms of withdrawal (See Additional Information for Patients). Contact your health care professional if you experience increased pain, withdrawal symptoms, changes in your mood, or thoughts of suicide.

Additional Information for Patients

Additional Information for Health Care Professionals

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

Revised: 4/2019
Zydus Pharmaceuticals (USA) Inc.