Embeda extended-release capsules

Generic Name: morphine/naltrexone (MOR-feen/nal-TREX-one)
Brand Name: Embeda

Embeda extended-release capsules is a narcotic pain medicine that may become habit-forming. Misuse or abuse can lead to overdose and death. Do NOT take more than the recommended dose, take for longer than prescribed, or take more often than prescribed without checking with your doctor.

Embeda extended-release capsules may cause severe and sometimes fatal breathing problems. The risk may be greater when you first start this drug or with any increase in dose. Contact your doctor right away if you experience slow, shallow, or difficult breathing.

Be sure to swallow Embeda extended-release capsules whole. Do NOT break, crush, cut, chew, or dissolve Embeda extended-release capsules before swallowing it. Do NOT inject Embeda extended-release capsules. Doing any of these things could result in very serious side effects, including severe trouble breathing and death from overdose. Doing this may also release the naltrexone in Embeda extended-release capsules, which may cause withdrawal symptoms. If you cannot swallow Embeda extended-release capsules whole, you may open it and sprinkle the contents over a spoonful of applesauce. Swallow the mixture right away, followed by a glass of water. Do not crush or chew the medicine before swallowing. Do not store the mixture for future use.

Accidental swallowing of Embeda extended-release capsules may be fatal, especially in children. Keep Embeda extended-release capsules out of the reach of children. Seek emergency medical care right away if another person swallows Embeda extended-release capsules.

Do NOT drink alcohol or take medicines (prescription or nonprescription) that contain alcohol while you are taking Embeda extended-release capsules. This could cause a fatal overdose. If you are unsure if any of your medicines contain alcohol, check with your doctor or pharmacist.

Long-term use of Embeda extended-release capsules during pregnancy may cause dependence in the unborn baby. This can lead to withdrawal in the newborn, which can be life-threatening. Discuss any questions or concerns with your doctor.


Embeda extended-release capsules is used for:

Managing moderate to severe pain when continuous (around-the-clock) treatment is needed for an extended period of time. Embeda extended-release capsules is not for use right after surgery if you have not already been using narcotic pain medicines, if only occasional or as-needed pain relief is needed, or if the pain is mild or is not expected to last for an extended period of time.

A certain strength of Embeda extended-release capsules should only be used by patients who have already been taking other narcotic pain medicine on a regular schedule and are tolerant to its effects. The use of this strength by people who are not used to taking narcotic pain medicine may cause severe and sometimes fatal breathing problems.

Embeda extended-release capsules is a narcotic (opioid) pain medicine. It works in the brain and nervous system to reduce pain. Embeda extended-release capsules also contains naltrexone, an opioid receptor antagonist, inside a special coating. If Embeda extended-release capsules is crushed or chewed, the naltrexone will be released and may cause withdrawal symptoms.

Do NOT use Embeda extended-release capsules if:

  • you are allergic to any ingredient in Embeda extended-release capsules
  • you have narrowing of the stomach or bowels or known or suspected stomach or bowel blockage (eg, paralytic ileus)
  • you have slow, shallow, or difficult breathing
  • you have severe lung problems (eg, severe asthma) or you are having an asthma attack
  • you are taking mixed agonist/antagonist pain medicines (eg, buprenorphine, butorphanol, nalbuphine, pentazocine) or sodium oxybate (GHB)
  • you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or have taken an MAOI within the past 14 days

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

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Before using Embeda extended-release capsules:

Some medical conditions may interact with Embeda 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 or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have had an allergic reaction to other narcotic pain medicines (eg, codeine)
  • if you have a history of chronic obstructive pulmonary disease (COPD) or other lung or breathing problems (eg, asthma, emphysema, bronchitis), sleep apnea, curvature of the spine (scoliosis), a certain heart problem (cor pulmonale), high levels of carbon dioxide in the blood (hypercapnia or hypercarbia), or low levels of oxygen in the blood (hypoxia)
  • if you have severe drowsiness, increased pressure in the brain, a recent head injury, growths in the brain (eg, lesions, tumors), or a history of seizures (eg, epilepsy)
  • if you have a history of liver or kidney problems, gallbladder problems, pancreas problems (eg, pancreatitis), thyroid problems, urinary blockage or trouble urinating, enlarged prostate, or stomach or bowel problems (eg, blockage, inflammation)
  • if you have low blood pressure, dehydration, low blood volume, constipation, stomach pain, or poor health
  • if you drink alcohol, have symptoms of alcohol withdrawal, or have a history of suicidal thoughts or attempts
  • if you or a member of your family has a history of mental or mood problems (eg, depression), or alcohol or other substance abuse or dependence
  • if you are very overweight or have recently had or will be having surgery (eg, stomach or bowel surgery)
  • if you are taking another medicine that contains naltrexone
  • if you have never taken a narcotic pain medicine before
  • if you have a gastric or nasogastric tube

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

  • Phenothiazines (eg, chlorpromazine) because the risk of low blood pressure may be increased
  • Cimetidine, MAOIs (eg, phenelzine), quinidine, or sodium oxybate (GHB) because the risk of severe drowsiness, coma, confusion, or slowed or difficult breathing may be increased
  • Anticholinergics (eg, benztropine, scopolamine) because the risk of trouble urinating and constipation may be increased
  • Other narcotic pain medicines (eg, oxycodone) because they may increase the risk of Embeda extended-release capsules's side effects
  • Mixed agonist/antagonist pain medicines (eg, buprenorphine, butorphanol, nalbuphine, pentazocine) or naltrexone because they may decrease Embeda extended-release capsules's effectiveness and withdrawal may occur
  • Rifamycins (eg, rifampin) because they may decrease Embeda extended-release capsules's effectiveness
  • Diuretics (eg, furosemide, hydrochlorothiazide) because their effectiveness may be decreased by Embeda extended-release capsules

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

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

  • Embeda extended-release capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Embeda extended-release capsules refilled.
  • Take Embeda extended-release capsules by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
  • Embeda extended-release capsules must only be taken by mouth. Do not inject Embeda extended-release capsules.
  • Swallow Embeda extended-release capsules whole. Do not break, cut, dissolve, crush, or chew before swallowing.
  • If you cannot swallow the capsule whole, you may open it and sprinkle the contents over a tablespoonful of applesauce. Swallow the mixture right away, followed by a glass of water. Do not crush or chew the medicine before swallowing. Do not store the mixture for future use. Dispose of the empty capsule as directed by your doctor or pharmacist.
  • Do not suddenly stop taking Embeda extended-release capsules. You may have an increased risk of withdrawal symptoms (eg, nausea, vomiting, diarrhea, anxiety, shivering). If you need to stop taking Embeda extended-release capsules, your doctor will gradually lower your dose.
  • Embeda extended-release capsules works best if it is taken at the same time(s) each day. Do not miss any doses.
  • If you miss a dose of Embeda 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. Do not take more than your prescribed dose in 24 hours.

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

Important safety information:

  • Embeda extended-release capsules may cause dizziness, drowsiness, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Embeda extended-release capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Embeda extended-release capsules; the risk of severe drowsiness or breathing problems may be increased. Ask your pharmacist if you have questions about which medicines may increase the risk of these effects.
  • Do not drink alcohol or take medicines (prescription or nonprescription) that have alcohol in them while you are taking Embeda extended-release capsules. Ask your pharmacist if you have questions about whether any of your medicines have alcohol in them.
  • Embeda extended-release capsules may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
  • Do NOT take more than the recommended dose, take for longer than prescribed, or take more often than prescribed without checking with your doctor.
  • Embeda extended-release capsules may cause constipation. Talk with your doctor or pharmacist about using a stool softener or laxative to prevent constipation. It is also important to maintain a diet adequate in fiber, drink plenty of water, and exercise to prevent constipation. If you become constipated while taking Embeda extended-release capsules, talk with your doctor or pharmacist.
  • If your pain continues or becomes worse or if you have side effects that concern you, contact your doctor.
  • Tell your doctor or dentist that you take Embeda extended-release capsules before you receive any medical or dental care, emergency care, or surgery.
  • Seek emergency medical care right away if another person swallows Embeda extended-release capsules. Accidental swallowing of Embeda extended-release capsules may be fatal, especially in children.
  • Embeda extended-release capsules may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Embeda extended-release capsules.
  • Use Embeda extended-release capsules with caution in the ELDERLY; they may be more sensitive to its effects, especially breathing problems.
  • Embeda extended-release capsules should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Embeda extended-release capsules while you are pregnant. Long-term use of Embeda extended-release capsules during pregnancy may cause dependence in the fetus or newborn. Discuss any questions or concerns with your doctor. Embeda extended-release capsules is found in breast milk. Do not breast-feed while taking Embeda extended-release capsules.

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

Some people who use Embeda extended-release capsules for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you stop taking Embeda extended-release capsules suddenly, you may have WITHDRAWAL symptoms. These may include 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.

Possible side effects of Embeda 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; mild itching; mild stomach pain; nausea; tiredness; vomiting.

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, throat, or tongue); abnormal sighing; burning, numbness, or tingling; chest pain; confusion; fainting; fast, slow, or irregular heartbeat; hallucinations; memory problems; mental or mood changes (eg, agitation, depression); seizures; severe or persistent constipation, stomach pain, or vomiting; severe or persistent dizziness, drowsiness, headache, or light-headedness; shortness of breath; slow, shallow, or difficult breathing; stomach swelling; swelling of the hands, ankles, or feet; tremor; trouble talking, thinking, or walking; trouble urinating; unusual sweating; vision changes (eg, blurred vision).

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 or nails; cold and clammy skin; coma; fainting; limp muscles; pinpoint or enlarged pupils; severe dizziness, drowsiness, or light-headedness; shortness of breath; slow, shallow, or difficult breathing; slow or irregular heartbeat.

Proper storage of Embeda extended-release capsules:

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

General information:

  • If you have any questions about Embeda extended-release capsules, please talk with your doctor, pharmacist, or other health care provider.
  • Embeda 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 Embeda 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 Embeda 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 Embeda 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 Embeda extended-release capsules.

Issue Date: April 2, 2014
Database Edition 14.2.1.001
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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