IMPORTANT SAFETY INFORMATION ABOUT OPANA® ER
- Get emergency help right away if you take too much OPANA® ER (overdose). When you first start taking OPANA® 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 OPANA® ER with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, low blood pressure upon standing, fainting, coma, and death.
- Never give anyone your OPANA® ER. They could die from taking it. Store OPANA® ER away from children and in a safe place to prevent stealing or abuse. Selling or giving away OPANA® ER is against the law.
Do not take OPANA® ER if you have:
- Severe asthma, trouble breathing, or other lung problems
- A bowel blockage or have narrowing of the stomach or intestines
Before taking OPANA® ER, tell your healthcare provider if you have a history of:
- Head injury
- Seizures or convulsive disorders as you may experience seizures while taking OPANA® ER
- Problems urinating
- Liver, kidney, thyroid problems
- 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. Prolonged use of OPANA® ER during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
- Breastfeeding. Not recommended during treatment with OPANA® ER. It may harm your baby.
- Taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking OPANA® ER with certain other medicines can cause serious side effects that could lead to death.
When taking OPANA® ER:
- Do not change your dose. Take OPANA® ER exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed
- 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 your next dose at your usual time.
- Swallow OPANA® ER whole. Do not cut, break, chew, crush, dissolve, snort, or inject OPANA® ER, because this may cause you to overdose and die.
- To avoid choking on the tablet, OPANA® ER should be taken 1 tablet at a time. Do not pre-soak, lick, or wet the tablet before placing in your mouth.
- Call your healthcare provider if the dose you are taking does not control your pain.
- Do not stop taking OPANA® ER without talking to your healthcare provider.
- After you stop taking OPANA® ER, flush any unused tablets down the toilet.
While taking OPANA® ER, DO NOT:
- Drive or operate heavy machinery, until you know how OPANA® ER affects you. OPANA® 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 OPANA® ER may cause you to overdose and die.
Possible side effects of OPANA® ER include:
- Constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain.
Call your healthcare provider if any of these symptoms are severe.
Get emergency medical help if you have:
- Trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, throat or hands, hives, itching, rash, 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 OPANA® ER. Call your doctor for medical advice about side effects. You may report side effects to FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see full Prescribing Information, including Boxed WARNING and Medication Guide.