Manufactured by: Knoa Pharma LLC, Stamford, CT 06901-3431,
www.knoapharma.comor call 1-888-726-7535.
Marketed by: Rhodes Pharmaceuticals LLC, Wilson, NC 27893 US, http://rhodespharma.com, or call 1-888-873-5329.
Medication Guide
Morphine Sulfate (Mor-feen-SUL-fate) Extended-Release (ER) Tablets, CII
Morphine sulfate ER tablets are:
- A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage severe and persistent pain that required an extended treatment period with a daily opioid pain medicine, when other pain 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 to be taken on an "as needed" basis.
Important information about morphine sulfate ER tablets:
- Get emergency help or call 911 right away if you take too much morphine sulfate ER tablets (overdose). When you first start taking morphine sulfate ER tablets, 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. Ask your healthcare provider about medicines like naloxone or nalmefene that can be used in an emergency to reverse an opioid overdose.
- Taking morphine sulfate ER tablets with other opioid medicines, benzodiazepines, gabapentinoids (gabapentin or pregabalin), 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 ER tablets. They could die from taking it. Selling or giving away morphine sulfate ER tablets is against the law.
- Store morphine sulfate ER tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.
Do not take morphine sulfate ER tablets if you have:
- severe asthma, trouble breathing, or other lung problems.
- a bowel blockage or have narrowing of the stomach or intestines.
Before taking morphine sulfate ER tablets, tell your healthcare provider if you have a history of:
- head injury, seizures
- problems urinating
- liver, kidney, thyroid problems
- pancreas or gallbladder problems
- abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems.
Tell your healthcare provider if you are:
- Noticing your pain getting worse. If your pain gets worse after you take morphine sulfate extended-release tablets, do not take more of morphine sulfate ER tablets without first talking to your healthcare provider. Talk to your healthcare provider if the pain you have increases, if you feel more sensitive to pain, or if you have new pain after taking morphine sulfate extended-release tablets.
- Pregnant or planning to become pregnant. Use of morphine sulfate ER tablets for an extended period of time during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
- Breastfeeding. Not recommended during treatment with morphine sulfate ER tablets. It may harm your baby.
- Living in a household where there are small children or someone who has abused street or prescription drugs.
- Taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking morphine sulfate ER tablets with certain other medicines can cause serious side effects.
When taking morphine sulfate ER tablets:
- Do not change your dose. Take morphine sulfate ER tablets exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest duration.
- Take your prescribed dose every 8 to 12 hours, as directed by your healthcare provider. Do not take more than your prescribed dose. If you miss a dose, take your next dose at the usual time.
- Swallow morphine sulfate ER tablets whole. Do not cut, break, chew, crush, dissolve, snort, or inject morphine sulfate ER tablets because this may cause you to overdose and die.
- Call your healthcare provider if the dose you are taking does not control your pain.
- Do not stop taking morphine sulfate ER tablets without talking to your healthcare provider.
- Dispose of expired, unwanted, or unused morphine sulfate ER tablets 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.
While taking morphine sulfate ER tablets DO NOT:
- Drive or operate heavy machinery, until you know how morphine sulfate ER tablets affect you. Morphine sulfate ER tablets 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 ER tablets may cause you to overdose and die.
The possible side effects of morphine sulfate extended-release tablets 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 or call 911 right away 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 morphine sulfate ER tablets. Call your healthcare provider 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.