Embeda Extended-Release CapsulesGeneric Name: Morphine/Naltrexone
Embeda Extended-Release Capsules are a narcotic pain reliever used for around-the-clock treatment of moderate or severe pain. It should not be used to treat occasional pain.
Embeda Extended-Release Capsules should only be used by patients who have already been taking narcotic pain medicine and are tolerant to its effect. The use of Embeda Extended-Release Capsules by people who are not used to taking narcotic pain medicine may cause severe and sometimes fatal breathing problems.
Swallow Embeda Extended-Release Capsules whole. Do NOT crush, chew, or dissolve Embeda Extended-Release Capsules; it may cause the release of too much medicine into the bloodstream, which could be fatal. Doing this may also release the naltrexone in Embeda Extended-Release Capsules, which may cause withdrawal symptoms.
If you have trouble swallowing Embeda Extended-Release Capsules whole, you may sprinkle the contents of the capsule on a small amount of applesauce and then swallow the mixture. Do NOT chew, crush, or dissolve the contents of the capsule before swallowing.
Do not drink alcoholic beverages or take any prescription or nonprescription medicines that contain alcohol at any time while you are taking Embeda Extended-Release Capsules. Doing this may cause too much medicine to be absorbed too quickly and may cause severe or possibly fatal side effects.
Embeda Extended-Release Capsules are used for:
Managing moderate to severe pain that continues around-the-clock and is expected to last for a long period of time. Embeda Extended-Release Capsules are used in patients who have already been taking narcotic pain medicine and are tolerant to its effects.
Embeda Extended-Release Capsules are a narcotic pain reliever. It works in the brain to dull pain. Embeda Extended-Release Capsules also contains naltrexone, an opioid receptor antagonist, inside a special coating. If Embeda Extended-Release Capsules are 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 paralysis of the stomach or intestines
- you have very slow or shallow breathing, severe asthma, hypercapnia (high levels of carbon dioxide in your blood), or you are having an asthma attack
- you are taking sodium oxybate (GHB)
- you are taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the past 14 days
Contact your doctor or health care provider right away if any of these apply to you.
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 are allergic to other narcotic pain medicines (eg, codeine)
- if you have diarrhea or constipation, are dehydrated, have low blood volume, or are in shock
- if you have severe drowsiness or are very weak, very overweight, or in very poor health
- if you have increased pressure in the head, a recent head injury, or an abnormal growth in the brain
- if you have gallbladder problems, pancreas problems (eg, inflammation), bladder blockage or trouble urinating, enlarged prostate, stomach or bowel problems (eg, blockage, inflammation, severe diarrhea caused by antibiotic use), or have had recent stomach or bowel surgery
- if you have a history of liver or kidney problems, heart problems (eg, cor pulmonale), low blood pressure, lung or breathing problems (eg, asthma, chronic obstructive pulmonary disease [COPD]), sleep apnea (trouble breathing when you sleep), thyroid problems (eg, underactive thyroid), adrenal gland problems (eg, Addison disease), or curvature of the spine (eg, scoliosis)
- if you have a history of seizures, mental or mood problems (eg, hallucinations), suicidal thoughts or actions, alcohol or other substance abuse or dependence, or if you are currently experiencing alcohol withdrawal
- if you are taking another medicine that contains naltrexone
- if you will be having surgery, or 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:
- Cimetidine, MAOIs (eg, phenelzine), muscle relaxants (eg, cyclobenzaprine), other narcotic pain medicines (eg, oxycodone), phenothiazines (eg, chlorpromazine), or quinidine because the risk of severe side effects (eg, severe drowsiness, very slow or shallow breathing, confusion, seizures) may be increased
- Anticholinergics (eg, scopolamine) because the risk of trouble urinating and severe constipation may be increased
- Narcotic agonists/antagonists (eg, pentazocine) or rifampin because they may decrease Embeda Extended-Release Capsules's effectiveness
- Sodium oxybate (GHB) because the risk of its side effects may be increased by Embeda Extended-Release Capsules
- Diuretics (eg, furosemide, hydrochlorothiazide) or trovafloxacin 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.
- Swallow Embeda Extended-Release Capsules whole. Do not dissolve, crush, or chew before swallowing.
- If you cannot swallow the capsule whole, contact your doctor. You may be able to open the capsule and sprinkle the pellets over a tablespoonful of applesauce. If you do this, swallow the applesauce and pellet 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.
- Take Embeda Extended-Release Capsules on a regular schedule to get the most benefit from it.
- Taking Embeda Extended-Release Capsules at the same time each day will help you remember to take it.
- Embeda Extended-Release Capsules should not be used more often than every 12 hours.
- Do not suddenly stop taking Embeda Extended-Release Capsules. If you need to stop taking Embeda Extended-Release Capsules, your dose may need to be slowly lowered in order to avoid withdrawal symptoms. Discuss any questions or concerns with your doctor.
- 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.
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 or drowsiness. 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; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Do not drink alcohol or take any prescription or nonprescription medicines 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, lightheadedness, 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.
- Constipation is a common side effect of Embeda Extended-Release Capsules. Talk to your doctor about using laxatives or stool softeners to prevent or treat constipation while you use Embeda Extended-Release Capsules.
- Do not take more than the recommended dose or use more often than prescribed without checking with your doctor. If Embeda Extended-Release Capsules stops working well, 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.
- If you no longer need Embeda Extended-Release Capsules, check with your doctor or pharmacist about how to properly dispose of unused capsules.
- Use Embeda Extended-Release Capsules with caution in the ELDERLY; they may be more sensitive to its effects.
- 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 become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Embeda Extended-Release Capsules while you are pregnant. Embeda Extended-Release Capsules are 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; increased sweating; lightheadedness; mild itching; 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, or tongue); chest pain; confusion; fainting; hallucinations; mental or mood changes; numbness of an arm or leg; pounding in the chest; seizures; severe dizziness or drowsiness; shortness of breath; slow, shallow breathing; sudden, severe nausea, vomiting, or headache.
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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include cold and clammy skin; convulsions; deep sleep; lightheadedness; limp muscles; loss of consciousness; low body temperature; pinpoint pupils; severe dizziness or drowsiness; shortness of breath; slow, shallow breathing; slowed heartbeat; wide pupils.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
- 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 are 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.
This information is a summary only. It does not contain all information about Embeda Extended-Release Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.