|This Medication Guide has been approved by the U.S. Food and Drug Administration|
Revised: December 2016; LAB-0643-2.0
(morphine sulfate and naltrexone hydrochloride) extended-release capsules, CII
Important information about EMBEDA:|
Do not take EMBEDA if you have:|
|Before taking EMBEDA, tell your healthcare provider if you have a history of:|
Tell your healthcare provider if you are:
When taking EMBEDA:|
While taking EMBEDA DO NOT:|
The possible side effects of EMBEDA are:|
Get emergency medical help if you have:
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 FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov
Manufactured for: Pfizer Inc, New York, NY 10017 by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207, www.embeda.com or call 1-800-438-1985
Instructions For Use
(morphine sulfate and naltrexone hydrochloride) extended-release Capsules, CII
- If you cannot swallow EMBEDA® capsules, tell your healthcare provider. There may be another way to take EMBEDA® that may be right for you. If your healthcare provider tells you that you can take EMBEDA® using this other way, follow these steps:
- EMBEDA® can be opened and the pellets inside the capsule can be sprinkled over applesauce, as follows:
- Open the EMBEDA® capsule and sprinkle the pellets over approximately one tablespoon of applesauce (See Figure 1).
- Swallow all of the applesauce and pellets right away. Do not save any of the applesauce and pellets for another dose (See Figure 2).
- Rinse your mouth to make sure you have swallowed all of the pellets. Do not chew the pellets (See Figure 3).
- Flush the empty capsule down the toilet right away (See Figure 4).
- You should not receive EMBEDA® through a nasogastric tube or gastric tube (stomach tube).
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured for: Pfizer Inc, New York, NY 10017
by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207
Revised April 2014