(oxycodone hydrochloride) Tablets USP, CII
- A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require an opioid pain medicine, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
- An 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.
Important information about ROXICODONE:
Get emergency help right away if you take too much ROXICODONE (overdose). When you first start taking ROXICODONE, 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 ROXICODONE 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 ROXICODONE. They could die from taking it. Selling or giving away ROXICODONE is against the law.
- Store ROXICODONE securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.
Do not take ROXICODONE if you have:
- severe asthma, trouble breathing, or other lung problems.
- a bowel blockage or have narrowing of the stomach or intestines.
- allergy to oxycodone.
Before taking ROXICODONE, tell your healthcare provider if you have a history of:
- head injury, seizures
- problems urinating
- abuse of street or prescription drugs, alcohol addiction, or mental health problems.
- liver, kidney, thyroid problems
- pancreas or gallbladder problems
Tell your healthcare provider if you are:
pregnant or planning to become pregnant. Prolonged use of ROXICODONE during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
breastfeeding. ROXICODONE passes into breast milk and may harm your baby.
- taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking ROXICODONE with certain other medicines can cause serious side effects that could lead to death.
When taking ROXICODONE:
- Do not change your dose. Take ROXICODONE exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
- Take your prescribed dose every 4 to 6 hours. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
- Call your healthcare provider if the dose you are taking does not control your pain.
- If you have been taking ROXICODONE regularly, do not stop taking ROXICODONE without talking to your healthcare provider.
- Dispose of expired, unwanted, or unused ROXICODONE by promptly flushing down the toilet, if a drug take-back option is not readily available. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.
While taking ROXICODONE DO NOT:
- Drive or operate heavy machinery, until you know how ROXICODONE affects you. ROXICODONE 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 ROXICODONE may cause you to overdose and die.
The possible side effects of ROXICODONE 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 ROXICODONE. 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: SpecGx LLC, Webster Groves, MO 63119 USA, www.Mallinckrodt.com or call 1-800-778-7898