Ryzolt extended-release tablets

Generic Name: tramadol (TRAM-a-dol)
Brand Name: Examples include Ultram ER and Ryzolt

Ryzolt extended-release tablets is used for:

Treating moderate to moderately severe chronic pain in certain patients.

Ryzolt extended-release tablets is an analgesic. It works in certain areas of the brain and nervous system to decrease pain.

Do NOT use Ryzolt extended-release tablets if:

  • you are allergic to any ingredient in Ryzolt extended-release tablets
  • you have had a severe allergic reaction (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue) to codeine or another opioid (eg, morphine)
  • you have severe or persistent diarrhea due to taking an antibiotic
  • you have suicidal thoughts or actions or a history of alcohol or other substance abuse or addiction
  • you are intoxicated with alcohol, opioids or narcotics (eg, codeine, morphine), or sedatives or sleeping medicines (eg, temazepam, zolpidem)
  • you have severe liver or kidney problems
  • you are taking carbamazepine, sodium oxybate (GHB), or another product that contains tramadol

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: 2014 Update: First Time Brand-to-Generic Switches

Before using Ryzolt extended-release tablets:

Some medical conditions may interact with Ryzolt extended-release tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription (especially depression medicines) or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have liver, kidney, or thyroid problems; a blockage in the bladder; diabetes; heart problems (eg, cor pulmonale); high blood pressure; pancreas problems; prostate problems; or metabolism problems
  • if you have or recently have had any head injury, brain injury or tumor, increased pressure in the brain, or infection of the brain or nervous system
  • if you have a history of recent stomach or bowel surgery, or any other stomach or bowel problems (eg, pain, inflammation, ulcers)
  • if you have a history of lung or breathing problems (eg, asthma, chronic obstructive pulmonary disease [COPD]) or seizures (eg, epilepsy)
  • if you drink alcohol; you are going through withdrawal from alcohol or other substances; or if you have a history of alcohol or other substance abuse or addiction, mood or mental problems (eg, depression), or suicidal thoughts or actions

Some MEDICINES MAY INTERACT with Ryzolt extended-release tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Alpha-2 receptor blockers (eg, yohimbine), anorexiants (eg, phentermine), butyrophenones (eg, haloperidol), cyclobenzaprine, furazolidone, linezolid, lithium, loxapine, certain medicines for mental or mood disorders (eg, olanzapine), molindone, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine, selegiline), nefazodone, phenothiazines (eg, promethazine), selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine, paroxetine), serotonin-norepinephrine reuptake inhibitors (SNRIs) (eg, duloxetine), St. John's wort, thioxanthenes (eg, thiothixene), tiagabine, tricyclic antidepressants (eg, amitriptyline), or "triptans" (eg, sumatriptan) because the risk of seizures or a serious side effect called serotonin syndrome may be increased
  • Azole antifungals (eg, ketoconazole), macrolide antibiotics (eg, erythromycin), opioid pain medicines (eg, codeine, hydrocodone), quinidine, sleeping medicines (eg, zolpidem), sodium oxybate (GHB), or other products containing tramadol because they may increase the risk of Ryzolt extended-release tablets's side effects
  • Carbamazepine or rifampin because they may decrease Ryzolt extended-release tablets's effectiveness
  • Anticoagulants (eg, warfarin) or digoxin because the risk of their side effects may be increased by Ryzolt extended-release tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ryzolt extended-release tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Ryzolt extended-release tablets:

Use Ryzolt extended-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take Ryzolt extended-release tablets by mouth with or without food. Try to take it the same way (either with food or without food) each time you take your dose. Check with your doctor or pharmacist if you have questions about taking Ryzolt extended-release tablets with food.
  • Swallow Ryzolt extended-release tablets whole. Do not break, crush, or chew before swallowing.
  • If you miss a dose of Ryzolt extended-release tablets and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Ryzolt extended-release tablets.

Important safety information:

  • Ryzolt extended-release tablets may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Ryzolt extended-release tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol while you are taking Ryzolt extended-release tablets.
  • Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers, narcotic pain medicines) while you are using Ryzolt extended-release tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Ryzolt extended-release tablets may cause dizziness; alcohol, hot weather, exercise, or fever may increase this effect. To prevent it, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of this effect.
  • Do NOT take more than the recommended dose or take for longer than prescribed without checking with your doctor.
  • Tell your doctor or dentist that you take Ryzolt extended-release tablets before you receive any medical or dental care, emergency care, or surgery.
  • Ryzolt extended-release tablets may increase your risk of seizures. Your risk may be greater if you also have certain medical conditions, use certain medicines, or if you use a lot of alcohol. Talk to your doctor to see if you may have a greater risk of seizures while taking Ryzolt extended-release tablets.
  • Serotonin syndrome is a possibly fatal syndrome that can be caused by Ryzolt extended-release tablets. Your risk may be greater if you take Ryzolt extended-release tablets with certain other medicines (eg, "triptans," MAOIs, antidepressants). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms.
  • Use Ryzolt extended-release tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially constipation, weakness or tiredness, severe light-headedness, and indigestion.
  • Ryzolt extended-release tablets should not be used in CHILDREN younger than 16 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Ryzolt extended-release tablets may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Ryzolt extended-release tablets while you are pregnant. Ryzolt extended-release tablets is found in breast milk. Do not breast-feed while taking Ryzolt extended-release tablets.

When used for long periods of time or at high doses, Ryzolt extended-release tablets may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Ryzolt extended-release tablets stops working well. Do not take more than prescribed.

Some people who use Ryzolt extended-release tablets for a long time without a break may develop a physical need to continue taking it. This is known as physical DEPENDENCE.

If you suddenly stop taking Ryzolt extended-release tablets, you may experience WITHDRAWAL symptoms, including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping. Do not suddenly stop taking Ryzolt extended-release tablets without talking with your doctor. If you need to stop Ryzolt extended-release tablets, your doctor will lower your dose over time.

Possible side effects of Ryzolt extended-release tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; dry mouth; headache; indigestion; mild itching; mildly increased sweating; nausea; trouble sleeping; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); agitation; chest pain; confusion; difficult or painful urination; excessive sweating; fainting; fast or irregular heartbeat; fever; hallucinations; loss of coordination; mood or mental changes (eg, depression); red, blistered, swollen, or peeling skin; seizures; severe dizziness or light-headedness; severe nausea, vomiting, or diarrhea; severe or persistent headache; slow or shallow breathing; suicidal thoughts or behaviors; tremor; vision problems.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include bluish skin; cold, clammy skin; difficult, shallow, or slow breathing; drowsiness leading to unresponsiveness or coma; excessive sweating; limp muscles; pinpoint pupils; seizures; slow or irregular heartbeat.

Proper storage of Ryzolt extended-release tablets:

Store Ryzolt extended-release tablets at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ryzolt extended-release tablets out of the reach of children and away from pets.

General information:

  • If you have any questions about Ryzolt extended-release tablets, please talk with your doctor, pharmacist, or other health care provider.
  • Ryzolt extended-release tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Ryzolt extended-release tablets or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Ryzolt extended-release tablets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Ryzolt extended-release tablets. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Ryzolt extended-release tablets.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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