Morphine Extended-Release is an extended-release form of morphine that is normally taken only once a day. It should only be used for moderate to severe pain that requires continuous, around-the-clock treatment over a long period of time.

Do NOT use Morphine Extended-Release if you are:

• allergic to any ingredient in Morphine Extended-Release
• have or suspected paralysis of the intestines or antibiotic associated colitis
• taking cimetidine, sodium oxybate, or a tricyclic antidepressant
• you drink alcohol
• taking or have taken a monoamine oxidase (MAO) inhibitor within the past 14 days
• slowed breathing or severe asthma or you are having an asthma attack

Contact your doctor or health care provider right away if any of these apply to you.

Use Morphine Extended-Release as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Morphine Extended-Release may be taken with or without food. Swallow Morphine Extended-Release whole. Do not crush, chew, or dissolve Morphine Extended-Release. If capsules cannot be swallowed whole, you may open the capsule and sprinkle the contents on a small amount of applesauce right before taking. Rinse your mouth with water to make sure you swallow the pellets. Do not mix the pellets and store for future use.

Take Morphine Extended-Release regularly to receive the most benefit from it. Taking Morphine Extended-Release at the same time each day will help you remember to take it. If you are taking trovafloxacin, do not take Morphine Extended-Release within 4 hours of trovafloxacin.

Ask your health care provider any questions you may have about how to use Morphine Extended-Release.

Some medical conditions may interact with Morphine Extended-Release. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• are pregnant, planning to become pregnant, or are breast-feeding
• are taking any prescription
• taking any nonprescription medicine, herbal preparation, or dietary supplement
• you have allergies to medicines or other substances
• you have asthma, chronic obstructive pulmonary disease (COPD)
• you have a history of drug abuse or dependence
• you have increased pressure in the head
• a recent head injury, or lesions in the head
• you have difficulty urinating
• you have heart, liver, or thyroid disease
• you have hypercapnia (abnormally increased carbon dioxide tension in your arteries)
• you have curvature of the spine
• you have seizures
• you have a history of suicidal thoughts or behaviors
• you have low blood volume
• stomach blockage or inflammatory bowel disease
• have had stomach tract surgery
• are in shock

If you miss a dose of Morphine Extended-Release, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction:

• skin rash or hives
• difficulty breathing
• swelling of your face, lips, tongue, or throat

Call your doctor at once if you have any of these SERIOUS side effects:

• excessive drowsiness
• face or throat swelling
• fast, irregular, or slow heartbeat
• hallucinations
• itching
• pounding in the chest
• seizures
• shock
• shortness of breath
• sudden chest pain
• sweating

Other, less serious side effects may be more likely to occur. Continue to take morphine and talk to your doctor if you experience:

• constipation
• dizziness
• drowsiness
• headache
• lightheadedness
• mood changes
• nausea
• vomiting

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088)

Tell your health care provider if you are taking any other medicines, especially any of the following:

• fluoxetine
• naltrexone
• narcotic agonists/antagonists (Pentazocine®)
• rifampin
• risperidone
• thiopental
• cimetidine
• ethanol
• ketorolac
• phenelzine
• sodium oxybate
• amitriptyline
• mexiletine
• trovafloxacin

This may not be a complete list of all interactions that may occur. Ask your health care provider if Morphine Extended-Release may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.