Embeda Oral

This medication contains morphine in a long-acting form and naltrexone. It is used to treat moderate to severe long-term pain (usually lasting longer than a few days). Morphine is a narcotic pain reliever (opiate-type). It acts on certain centers in the brain to give you pain relief. Naltrexone belongs to a class of drugs known as narcotic antagonists. It is combined with morphine to prevent crushing/dissolving the medication for abuse/misuse.
The highest strength of this drug (100 milligrams per capsule) should be used only if you have been regularly taking moderate to large amounts of narcotic pain medication. This strength may cause overdose (even death) if taken by a person who has not been regularly taking narcotic medication.
Do not use the extended-release form of morphine to relieve pain that is mild or that will go away in a few days. This medication is not for occasional (\"as needed\") use.

How to use Embeda Oral
See also Warning section.
Read the Medication Guide provided by your pharmacist before you start taking this product and each time you get a refill. If you have any questions, consult your doctor or pharmacist.
Take this medication by mouth with or without food, usually once or twice daily or as directed by your doctor. Do not take more than 1 dose in 12 hours.
The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor\'s instructions carefully. Do not increase your dose, take the medication more frequently, or take it for a longer time than prescribed. Properly stop the medication when so directed.
Swallow the capsules whole. Do not crush, chew, or dissolve the capsules. Doing so can release all of the drug at once, increasing the risk of side effects.
If you are an adult and have trouble swallowing the capsule, you may open the capsule and carefully sprinkle its contents on a spoonful of soft, cool applesauce just before you take it. Swallow all of the drug/food mixture immediately without chewing. Then rinse your mouth and swallow the rinse liquid to make sure that you have swallowed all of the medicine. Do not chew the mixture or prepare a supply in advance. Do not give this medication through a tube into the stomach (such as a nasogastric tube).
Children should not be given this medication by opening the capsules and sprinkling it on applesauce. There is a risk that a child may chew the drug/food mixture, which can result in a fatal overdose of morphine. Talk to your doctor or pharmacist for more details.
Your doctor may direct you to take quick-acting narcotic or non-narcotic (such as naproxen, ibuprofen) pain medications for sudden (breakthrough) pain. Follow your doctor\'s or pharmacist\'s instructions for safely using these medications. If you have been using other long-acting narcotic pain medications or narcotic patches regularly, check with your doctor or pharmacist because you may need to stop using them before you start using this medication. If you are currently using a narcotic patch (such as fentanyl), the effects may continue after it is removed. Ask your doctor or pharmacist when it will be safe to start taking this medication.
This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as restlessness, vomiting, diarrhea, watery eyes, muscle aches, runny nose) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.
When this medication is used for a long time, it may not work as well. Your doctor may need to increase your dose or change your medication. Talk with your doctor if this medication stops working well.
Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.
Tell your doctor if your pain persists or worsens.

Drowsiness, dizziness, nausea, vomiting, constipation, lightheadedness, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).
To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, mental/mood changes (such as agitation, hallucinations, confusion), severe stomach/abdominal pain, difficulty urinating, change in the amount of urine.
Seek immediate medical attention if any of these rare but serious side effects occur: slow/shallow breathing, chest pain, slow/fast heartbeat, seizures.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking morphine, tell your doctor or pharmacist if you are allergic to morphine; or to naltrexone; or to other narcotic pain medications (such as codeine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), kidney disease, liver disease, mental/mood disorders (such as confusion, depression), personal or family history of regular use/abuse of drugs/alcohol, stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus), difficulty urinating (such as due to enlarged prostate), disease of the pancreas (pancreatitis), gallbladder disease.
This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Alcohol may worsen this effect. Avoid alcoholic beverages because they can lead to the sudden release of a very large (possibly fatal) amount of drug into your body.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Older adults may be more sensitive to the effects of this drug, especially dizziness, drowsiness, slow/shallow breathing, or urinary problems.
Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, take the smallest effective dose for the shortest possible time. Tell the doctor right away if you notice any symptoms in your newborn baby such as slow/shallow breathing, irritability, abnormal/persistent crying, vomiting, or diarrhea.
This drug passes into breast milk and may have undesirable effects on a nursing infant. Discuss the risks and benefits with your doctor before breast-feeding.

See also Warning section.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor\'s approval.
Some products that may interact with this drug include: products that contain alcohol (such as cough-and-cold syrups), anticholinergic drugs (such as benztropine, belladonna alkaloids, scopolamine), cimetidine, certain medications for pain (opiate partial agonists such as butorphanol, nalbuphine, pentazocine), \"water pills\" (diuretics such as hydrochlorothiazide, furosemide).
Other medications can affect the removal of this medication from your body, which may affect how it works. Examples include azole antifungals (such as itraconazole), macrolide antibiotics (such as erythromycin), quinidine, verapamil, among others.
The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if you take this medication with other products that may also affect breathing or cause drowsiness. Therefore, tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, psychiatric medications (such as risperidone, chlorpromazine, trazodone, amitriptyline) and narcotic pain relievers (such as codeine).
Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.
This medication may interfere with certain laboratory tests, possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: slow/shallow breathing, severe drowsiness, slow heartbeat, severe dizziness, pinpoint pupils.

NOTES:
Do not share this medication with others. It is against the law.
This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in that case.

MISSED DOSE:
If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE:
Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised September 2012. Copyright(c) 2012 First Databank, Inc.