EMBEDA - morphine sufate capsule, extended release 



EMBEDA™ (im-bed-a)
(morphine sulfate and naltrexone hydrochloride)
Extended Release Capsules CII

IMPORTANT: Keep EMBEDA in a safe place away from children. Accidental use by a child is a medical emergency and can result in death. If a child accidentally takes EMBEDA, get emergency help right away.

Read the Medication Guide that comes with EMBEDA before you start taking it and each time you get a new prescription. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. Share this important information with members of your household.

What Is the Most Important Information I Should Know About EMBEDA?

See the section “What are the possible side effects of EMBEDA?” for more information about side effects.

What is EMBEDA?

Who Should Not Take EMBEDA?

Do not take EMBEDA if you:

What Should I Tell My Healthcare Provider Before Starting EMBEDA?

Ask your healthcare provider if you are not sure if your medicine is one listed above.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How Should I Take EMBEDA?

EMBEDA can be opened and the pellets inside the capsule can be sprinkled over apple sauce, as follows:

What Should I Avoid While Taking EMBEDA?

What are the Possible Side Effects of EMBEDA?

EMBEDA can cause serious side effects, including:

These can be symptoms that you have taken too much EMBEDA (overdose) or the dose is too high for you. These symptoms may lead to serious problems or death if not treated right away.

General Information about EMBEDA

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use EMBEDA for conditions for which it was not prescribed. Do not give EMBEDA to other people, even if they have the same symptoms you have. It may harm them and even cause death. Sharing EMBEDA is against the law.

This medication guide summarizes the most important information about EMBEDA. If you would like more information, talk with your healthcare provider. Also, you can ask your pharmacist or healthcare provider for information about EMBEDA that is written for healthcare professionals. For more information call 1-800-776-3637 or go to www.kingpharm.com.

What are the ingredients in EMBEDA?

Active Ingredients: pellets of morphine sulfate and naltrexone hydrochloride

Inactive Ingredients common to all strengths: talc, ammonio methacrylate copolymer, sugar spheres, ethylcellulose, sodium chloride, polyethylene glycol, hydroxypropyl cellulose, dibutyl sebacate, methacrylic acid copolymer, diethyl phthalate, magnesium stearate, sodium lauryl sulfate, and ascorbic acid. The capsule shells contain gelatin, titanium dioxide, and grey ink, D and C yellow #10 (EMBEDA 20 mg/0.8 mg), FD and C red #3, FD and C blue #1 (EMBEDA 30 mg/1.2 mg), D and C red #28, FD and C red #40, FD and C blue #1 (EMBEDA 50 mg/2 mg), D and C red #28, FD and C red #40, FD and C blue #1 (EMBEDA 60 mg/2.4 mg), FD and C blue #1, FD and C red #40, FD and C yellow #6 (EMBEDA 80 mg/3.2 mg), D and C yellow #10, FD and C blue #1 (EMBEDA 100 mg/4 mg).

Manufactured for: King Pharmaceuticals, Inc., 501 Fifth Street, Bristol, TN 37620

(Telephone: 1-800-776-3637)

by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207 USA

EMBEDA is a trademark of Alpharma Pharmaceuticals LLC, a wholly owned subsidiary of King Pharmaceuticals, Inc.


Revision: June 2009

This Medication Guide has been approved by the U.S. Food and Drug Administration


Revised: 1/2010