MEDGICATION GUIDE

Oxymorphone Hydrochloride Extended-Release Tablets, CII

Rx only

Oxymorphone Hydrochloride 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 Oxymorphone Hydrochloride Extended-Release Tablets:

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

Do not take Oxymorphone Hydrochloride 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 Oxymorphone Hydrochloride Extended-Release Tablets, 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. Oxymorphone hydrochloride extended-release tablets may harm your unborn baby.
• breastfeeding.  Oxymorphone hydrochloride may pass into breast milk and may harm your baby.
• taking prescription or over-the-counter medicines, vitamins, or herbal supplements.

When taking Oxymorphone Hydrochloride Extended-Release Tablets:

• Do not change your dose. Take oxymorphone hydrochloride extended-release tablets exactly as prescribed by your healthcare provider.
• Take your prescribed dose every 12 hours at the same time every day on an empty stomach, at least 1 hour before or 2 hours after meals. Do not take more than your prescribed dose in 24 hours. If you miss a dose, take the missed dose 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.
• Swallow oxymorphone hydrochloride extended-release tablets whole. Do not cut, break, chew, crush, dissolve, or inject oxymorphone hydrochloride extended-release tablets.
• Call your healthcare provider if the dose you are taking does not control your pain.
• Do not stop taking oxymorphone hydrochloride extended-release tablets without talking to your healthcare provider.
• After you stop taking oxymorphone hydrochloride extended-release tablets, flush any unused tablets down the toilet.

While taking Oxymorphone Hydrochloride Extended-Release Tablets Do Not:

• Drive or operate heavy machinery,until you know how oxymorphone hydrochloride extended-release tablets affect you. Oxymorphone hydrochloride 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 Oxymorphone Hydrochloride Extended-Release Tablets:

• 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 oxymorphone hydrochloride 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.  For more information about oxymorphone hydrochloride extended-release tablets, call Actavis at 1-800-432-8534.

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

Manufactured by:

Actavis Elizabeth LLC

200 Elmora Avenue

Elizabeth, NJ 07207 USA

40-9113

(MG 41-1184/0712)