Medication Guide

ARYMO ® ER (AIR ĭ mow) (morphine sulfate) extended-release tablets, CII

ARYMO ER is:

• 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.

Important information about ARYMO ER:

• Get emergency help right away if you take too much ARYMO ER (overdose). When you first start taking ARYMO ER, 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.
• Taking ARYMO ER 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 ARYMO ER. They could die from taking it. Store ARYMO ER away from children and in a safe place to prevent stealing or abuse. Selling or giving away ARYMO ER is against the law.

Do not take ARYMO ER if you have:

• severe asthma, trouble breathing, or other lung problems.
• a bowel blockage or have narrowing of the stomach or intestines.

When taking ARYMO ER:

• Do not change your dose. Take ARYMO ER exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
• 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 ARYMO ER whole. Do not cut, break, chew, crush, dissolve, snort, or inject ARYMO ER because this may cause you to overdose and die.
• ARYMO ER should be taken one tablet at a time. Do not pre-soak, lick, or wet the tablet before placing in your mouth to avoid choking on the tablet.
• Call your healthcare provider if the dose you are taking does not control your pain.
• Do not stop taking ARYMO ER without talking to your healthcare provider.
• After you stop taking ARYMO ER, flush any unused tablets down the toilet.

While taking ARYMO ER DO NOT:

• Drive or operate heavy machinery, until you know how ARYMO ER affects you. ARYMO ER 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 ARYMO ER may cause you to overdose and die.

The possible side effects of ARYMO ER 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, 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 ARYMO ER. 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

Distributed by: Zyla Life Sciences US Inc., Wayne, PA 19087, www.Zyla.com or call 1-800-518-1084