Medication Guide
AVINZA® (ah-ven-zah) (morphine sulfate) extended-release capsules, CII

AVINZA 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 AVINZA:

• Get emergency help right away if you take too much AVINZA (overdose). When you first start taking AVINZA, 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.
• Never give anyone your AVINZA. They could die from taking it. Store AVINZA away from children and in a safe place to prevent stealing or abuse. Selling or giving away AVINZA is against the law.

Do not take AVINZA if you have:

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

Tell your healthcare provider if you are:

• pregnant or planning to become pregnant. Prolonged use of AVINZA during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
• breastfeeding. AVINZA passes into breast milk and may harm your baby.
• taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking AVINZA with certain other medicines can cause serious side effects.

When taking AVINZA:

• Do not change your dose. Take AVINZA exactly as prescribed by your healthcare provider.
• Take your prescribed dose every 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 the next day.
• Swallow AVINZA whole. Do not cut, break, chew, crush, dissolve, snort, or inject AVINZA because this may cause you to overdose and die.
• If you cannot swallow AVINZA capsules, see the detailed Instructions for Use.
• Call your healthcare provider if the dose you are taking does not control your pain.
• Do not stop taking AVINZA without talking to your healthcare provider.
• After you stop taking AVINZA, flush any unused capsules down the toilet.

While taking AVINZA DO NOT:

• Drive or operate heavy machinery, until you know how AVINZA affects you. AVINZA can make you sleepy, dizzy, or lightheaded.
• Drink alcohol, or use prescription or over-the-counter medicines containing alcohol. Using products containing alcohol during treatment with AVINZA may cause you to overdose and die.

The possible side effects of AVINZA 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, or you are feeling faint.

These are not all the possible side effects of AVINZA. 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: Pfizer Inc, New York, NY 10017 by: Alkermes Gainesville LLC, Gainesville, GA, www.avinza.com or call 1-800-438-1985

This Medication Guide has been approved by the U.S. Food and Drug Administration

LAB-0630-2.0

April 2014