MEDICATION GUIDE

Morphine Sulfate Extended-Release (ER) Tablets, CII

Morphine sulfate extended-release tablets are:

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

Important information about morphine sulfate extended-release tablets:

• Get emergency help right away if you take too much morphine sulfate ER tablets (overdose). Morphine sulfate ER overdose can cause life threatening breathing problems that can lead to death.
• Never give anyone else your morphine sulfate extended-release tablets. They could die from taking it. Store morphine sulfate ER tablets away from children and in a safe place to prevent stealing or abuse. Selling or giving away morphine sulfate extended-release tablets is against the law.

Do not take morphine sulfate extended-release 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, 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.  Morphine sulfate may harm your unborn baby.
• breastfeeding. Morphine sulfate passes into breast milk and may harm your baby.
• taking prescription or over-the-counter medicines, vitamins, or herbal supplements.

When taking morphine sulfate extended-release tablets:

• Do not change your dose. Take morphine sulfate extended-release tablets exactly as prescribed by your healthcare provider.
• Take each dose at the same time every day. If you miss a dose, take morphine sulfate extended-release tablets as soon as possible and then take your next dose 8 or 12 hours later as directed by your healthcare provider. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take more than 1 dose in 8 hours.
• Swallow morphine sulfate extended-release tablets whole. Do not cut, break, chew, crush, dissolve, or inject morphine sulfate extended-release tablets.
• Call your healthcare provider if the dose you are taking does not control your pain.
• Do not stop taking morphine sulfate ER without talking to your healthcare provider.
• After you stop taking morphine sulfate ER tablets, flush any unused tablets down the toilet.

While taking morphine sulfate extended-release tablets Do Not:

• Drive or operate heavy machinery, until you know how morphine sulfate extended-release tablets affect you. Morphine sulfate extended-release tablets can make you sleepy, dizzy, or lightheaded.
• Drink alcohol or use prescription or over-the-counter medicines that contain alcohol.

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 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.

These are not all the possible side effects of morphine sulfate extended-release tablets. 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:  Rhodes Pharmaceuticals L.P., or call 1-888-827-0616                   302828-0A
This Medication Guide has been approved by the U.S. FDA                                          Issue: 07/2012