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IMPORTANT SAFETY INFORMATION
Get emergency help right away if you take too much EMBEDA® (morphine sulfate and naltrexone hydrochloride) extended-release capsules, for oral use, CII (overdose). When you first start taking EMBEDA, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Never give anyone your EMBEDA. They could die from taking it. Store EMBEDA away from children and in a safe place to prevent stealing or abuse. Selling or giving away EMBEDA is against the law.
Do not take EMBEDA if you have severe asthma, trouble breathing, or other lung problems or if you have a bowel blockage or have narrowing of the stomach or intestines.
Before taking EMBEDA tell your healthcare provider if you have a history of head injury, seizures, liver, kidney, thyroid problems, problems urinating, pancreas or gallbladder problems, abuse of street or prescription drugs, alcohol addiction, or mental health problems.
Tell your healthcare provider if you are pregnant or planning to become pregnant. Prolonged use of EMBEDA during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. Symptoms of withdrawal in newborns are irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight. Tell your healthcare provider if you are breastfeeding as EMBEDA passes into breast milk and may harm your baby. Tell your healthcare provider if you are taking prescriptions or over-the-counter medicines, vitamins, or herbal supplements. Taking EMBEDA with certain other medicines can cause serious side effects.
Take EMBEDA exactly as prescribed by your healthcare provider and do not change your dose. Take your prescribed dose every 12 or 24 hours, at the same time every day. Do not take more than your prescribed dose within a 24 hour period. If you miss a dose, take your next dose at your usual time.
Swallow EMBEDA whole. Do not cut, break, chew, crush, dissolve, snort or inject EMBEDA because this may cause you to overdose and die. If you cannot swallow EMBEDA capsules sprinkle the pellets inside the capsule on applesauce and swallow immediately without chewing. See the detailed Instructions for Use. You should not receive EMBEDA through a nasogastric tube or gastric tube (stomach tube).
Call your healthcare provider if the dose you are taking does not control your pain. Do not stop taking EMBEDA without talking to your healthcare provider. After you stop taking EMBEDA, flush any unused capsules down the toilet.
While taking EMBEDA, do not drive or operate heavy machinery until you know how EMBEDA affects you. EMBEDA can make you sleepy, dizzy, or lightheaded.
Do not drink alcohol or use prescription or over-the-counter medicines that contain alcohol as these may cause you to overdose and die. Tell your healthcare provider about other prescription medicines you are taking as certain medicines can also increase the risk of breathing problems.
The possible side effects of EMBEDA are constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.
Get emergency medical help if you have trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue or throat, extreme drowsiness, light-headedness when changing positions or you are feeling faint.
What is EMBEDA?
EMBEDA is a strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily, around-the-clock, long-term treatment with an opioid when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them. EMBEDA is a long-acting (extended-release) opioid pain medicine that can put you at risk for overdose, opioid addiction, abuse and misuse that can lead to death. Do not use to treat pain that is not around-the-clock.
Click here for Full Prescribing Information, including BOXED WARNING and Medication Guide.
The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient.
Patients should always ask their doctors for medical advice about adverse events. You may report an adverse event related to Pfizer products by calling 1-800-438-1985 (U.S. only).
If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. The FDA has established a reporting service known as MedWatch where healthcare professionals and consumers can report serious problems they suspect may be associated with the drugs and medical devices they prescribe, dispense, or use. Visit MedWatch or call 1-800-FDA-1088.
The product information provided in this site is intended for residents of the United States. The products discussed herein may have different product labeling in different countries.
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