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IMPORTANT INFORMATION FOR PATIENTS AND PRESCRIBERS

In March 2011, Pfizer Inc voluntarily recalled from US wholesalers and retailers all dosage forms of EMBEDA® (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules CII because a prespecified requirement was not met during routine testing.

On November 4, 2013, the U.S. Food and Drug Administration (FDA) approved a Prior Approval Supplement for EMBEDA that included an update to the EMBEDA manufacturing process addressing the prespecified stability requirements.

Pfizer anticipates product availability in the second quarter of 2014.

What is EMBEDA?

EMBEDA is a strong prescription pain medicine that contains an opioid (narcotic) that is used to treat moderate to severe around-the-clock pain.

IMPORTANT SAFETY INFORMATION

Get emergency help right away if you take too much EMBEDA® (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules CII (overdose). EMBEDA overdose can cause life threatening breathing problems that can lead to death. Never give anyone else 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® (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules CII, 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 as EMBEDA may harm your unborn baby. Tell your healthcare provider if you are breastfeeding as EMBEDA passes into breast milk and may harm your baby.

Take EMBEDA exactly as prescribed by your healthcare provider and do not change your dose. Do not take more than your prescribed dose in 24 hours. If you miss a dose, take EMBEDA as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not take 2 doses at the same time unless your healthcare provider tells you to.

Swallow EMBEDA whole. Do not cut, break, chew, crush, dissolve, or inject EMBEDA. If you cannot swallow EMBEDA capsules sprinkle the pellets inside the capsule on applesauce and swallow whole without chewing. See the detailed Instructions for Use.

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 can increase the risk of breathing problems when taking EMBEDA. 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, or you are feeling faint.

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 (US 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 health care 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.

Please scroll for Important Safety Information and Indication.

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