HYSINGLA™ ER (hye-SING-luh)
(hydrocodone bitartrate) extended-release tablets, CII
|HYSINGLA 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 HYSINGLA ER:
- Get emergency help right away if you take too much HYSINGLA ER (overdose). When you first start taking HYSINGLA 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 HYSINGLA 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 HYSINGLA ER. They could die from taking it. Store HYSINGLA ER away from children and in a safe place to prevent stealing or abuse. Selling or giving away HYSINGLA ER is against the law.
|Do not take HYSINGLA 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 HYSINGLA ER, tell your healthcare provider if you have a history of:
Tell your healthcare provider if you are:
- head injury, seizures
- liver, kidney, thyroid problems
- problems urinating
- pancreas or gallbladder problems
- heart rhythm problems (long QT syndrome)
- abuse of street or prescription drugs, alcohol addiction, or mental health problems
- pregnant or planning to become pregnant. Prolonged use of HYSINGLA 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 HYSINGLA ER. It may harm your baby.
- taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking HYSINGLA ER with certain other medicines can cause serious side effects and could lead to death.
|When taking HYSINGLA ER:
Call your healthcare provider if the dose you are taking does not control your pain.
- Do not change your dose. Take HYSINGLA ER exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
- 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 HYSINGLA ER whole. Do not cut, break, chew, crush, dissolve, snort, or inject HYSINGLA ER because this may cause you to overdose and die.
- HYSINGLA ER should be taken 1 tablet at a time. Do not pre-soak, lick, or wet the tablet before placing it in your mouth to avoid choking on the tablet.
- Do not stop taking HYSINGLA ER without talking to your healthcare provider.
- After you stop taking HYSINGLA ER, flush any unused tablets down the toilet.
|While taking HYSINGLA ER, DO NOT:
The possible side effects of HYSINGLA ER are:
- Drive or operate heavy machinery until you know how HYSINGLA ER affects you. HYSINGLA 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 HYSINGLA ER may cause you to overdose and die.
Get emergency medical help if you have:
- constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.
- 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 HYSINGLA 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.
Manufactured by: Purdue Pharma L.P., Stamford, CT 06901-3431, www.purduepharma.com or call 1-888-726-7535