Medication Guide
Morphine Sulfate (mor’ feen sul’ fate) Extended-Release Capsules, USP, CII |
Morphine sulfate extended-release capsules are:
- 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.
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Important information about morphine sulfate extended-release capsules:
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Get emergency help or call 911 right away if you take too much morphine sulfate extended-release capsules (overdose). When you first start taking morphine sulfate extended-release capsules, 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. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose.
- Taking morphine sulfate extended-release capsules 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 else your morphine sulfate extended-release capsules. They could die from taking it. Selling or giving away morphine sulfate extended-release capsules is against the law.
- Store morphine sulfate extended-release capsules securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.
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Do not take morphine sulfate extended-release capsules if you have:
- severe asthma, trouble breathing, or other lung problems.
- a bowel blockage or have narrowing of the stomach or intestines.
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Before taking morphine sulfate extended-release capsules, tell your healthcare provider if you have a history of:
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When taking morphine sulfate extended-release capsules:
- Do not change your dose. Take morphine sulfate extended-release capsules exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
- Take your prescribed dose every 12 or 24 hours at the same time every day. Do not take more than your prescribed dose in 24 hours. If you miss a dose, take your next dose at your usual time.
- Swallow morphine sulfate extended-release capsules whole. Do not cut, break, chew, crush, dissolve, snort, or inject morphine sulfate extended-release capsules because this may cause you to overdose and die.
- You should not receive morphine sulfate extended-release capsules through a nasogastric tube.
- If you cannot swallow morphine sulfate extended-release capsules, see the detailed Instructions for Use.
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Call your healthcare provider if the dose you are taking does not control your pain.
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Do not stop taking morphine sulfate extended-release capsules without talking to your healthcare provider.
- Dispose of expired, unwanted, or unused morphine sulfate extended-release capsules by promptly flushing down the toilet, if a drug take-back option is not readily available. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.
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While taking morphine sulfate extended-release capsules DO NOT:
- Drive or operate heavy machinery, until you know how morphine sulfate extended-release capsules affects you. Morphine sulfate extended-release capsules can make you sleepy, dizzy, or lightheaded.
- Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with morphine sulfate extended-release capsules may cause you to overdose and die.
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The possible side effects of morphine sulfate extended-release capsules are:
These are not all the possible side effects of morphine sulfate extended-release capsules. 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.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured by:
Amneal Pharmaceuticals of NY, LLC
Brookhaven, NY 11719
Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807
Rev. 12-2021-03 |