Tramadol extended-release capsules

Pronunciation

Generic Name: tramadol (TRAM-a-dol)
Brand Name: ConZip

Tramadol extended-release capsules is used for:

Treating moderate to moderately severe chronic pain in certain patients.

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

Do NOT use tramadol extended-release capsules if:

  • you are allergic to any ingredient in tramadol extended-release capsules
  • 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 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.

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Before using tramadol extended-release capsules:

Some medical conditions may interact with tramadol extended-release capsules. 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 bladder blockage; are at risk for seizures; or have a history of liver, kidney, or thyroid problems; seizures (eg, epilepsy); heart problems (eg, cor pulmonale); pancreas problems; prostate problems; or metabolism problems
  • you have severe or persistent diarrhea due to taking an antibiotic
  • 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 slow or shallow breathing, high levels of carbon dioxide in the blood (hypercapnia), or you have a history of lung or breathing problems (eg, asthma, chronic obstructive pulmonary disease [COPD])
  • if you drink alcohol; you are going through withdrawal from alcohol or other substances; or 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 tramadol extended-release capsules. 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 tramadol extended-release capsules's side effects
  • Carbamazepine or rifampin because they may decrease tramadol extended-release capsules's effectiveness
  • Anticoagulants (eg, warfarin) or digoxin because the risk of their side effects may be increased by tramadol extended-release capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if tramadol extended-release capsules 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 tramadol extended-release capsules:

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

  • Take tramadol extended-release capsules by mouth with or without food.
  • Swallow tramadol extended-release capsules whole with liquid. Do not break, crush, dissolve, or chew before swallowing.
  • Take tramadol extended-release capsules at the same time each day.
  • If you miss a dose of tramadol extended-release capsules, 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 tramadol extended-release capsules.

Important safety information:

  • Tramadol extended-release capsules may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use tramadol extended-release capsules 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 tramadol extended-release capsules.
  • Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers, narcotic pain medicines) while you are using tramadol extended-release capsules; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Tramadol extended-release capsules 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 tramadol extended-release capsules before you receive any medical or dental care, emergency care, or surgery.
  • Tramadol extended-release capsules 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 tramadol extended-release capsules.
  • Serotonin syndrome is a possibly fatal syndrome that can be caused by tramadol extended-release capsules. Your risk may be greater if you take tramadol extended-release capsules 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 tramadol extended-release capsules with caution in the ELDERLY; they may be more sensitive to its effects, especially constipation, weakness or tiredness, dizziness, drowsiness, severe light-headedness, nausea, or indigestion.
  • Tramadol extended-release capsules should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Tramadol extended-release capsules 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 tramadol extended-release capsules while you are pregnant. Tramadol extended-release capsules is found in breast milk. Do not breast-feed while taking tramadol extended-release capsules.

When used for long periods of time or at high doses, tramadol extended-release capsules 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 tramadol extended-release capsules stops working well. Do not take more than prescribed.

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

Do not suddenly stop taking tramadol extended-release capsules. If you suddenly stop it, 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. If you need to stop tramadol extended-release capsules, your doctor will lower your dose over time.

Possible side effects of tramadol extended-release capsules:

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; dizziness; drowsiness; dry mouth; headache; loss of appetite; 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); burning, numbness, or tingling; 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, agitation); 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; wheezing.

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; fainting; limp muscles; pinpoint pupils; seizures; severe or persistent dizziness or light-headedness; slow or irregular heartbeat.

Proper storage of tramadol extended-release capsules:

Store tramadol extended-release capsules 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 tramadol extended-release capsules out of the reach of children and away from pets.

General information:

  • If you have any questions about tramadol extended-release capsules, please talk with your doctor, pharmacist, or other health care provider.
  • Tramadol extended-release capsules 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 tramadol extended-release capsules 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 tramadol extended-release capsules. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to tramadol extended-release capsules. 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 tramadol extended-release capsules.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
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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