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IMPORTANT SAFETY INFORMATION
- Get emergency help right away if you take too much EMBEDA (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.
- Taking EMBEDA with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
- 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.
- 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
- problems urinating
- abuse of street or prescription drugs, alcohol addiction, or mental health problems.
- liver, kidney, thyroid problems
- pancreas or gallbladder 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.
- breastfeeding. Not recommended during treatment with EMBEDA. It may harm your baby.
- taking prescriptions or over-the-counter medicines, vitamins, or herbal supplements. Taking EMBEDA with certain other medicines can cause serious side effects and could lead to death.
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.
- Drink alcohol, or use prescription or over-the-counter medicines containing alcohol. Using products containing alcohol during treatment with EMBEDA may cause you to overdose and die.
- Chew, crush, or dissolve the capsule or the pellets to avoid the risk of release and absorption of a potentially fatal dose of morphine. EMBEDA also contains naltrexone, which can reverse the effects of morphine and can cause withdrawal if the EMBEDA capsule or pellets are chewed, crushed, or dissolved.
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, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.
These are not all the possible side effects of EMBEDA. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
What is EMBEDA?
- 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.
- A long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death.
- Not for use to treat pain that is not around-the-clock.
Click here for Full Prescribing Information, including BOXED WARNING and Medication Guide.
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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