Oxycodone, slow release (By mouth)

OxyCONTIN, Xtampza ER

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you are using or have used an MAO inhibitor within the past 14 days.
• Some medicines can affect how oxycodone works. Tell your doctor if you are using any of the following:
  • Carbamazepine, erythromycin, ketoconazole, mirtazapine, phenytoin, rifampin, ritonavir, tramadol, or trazodone
  • Diuretic (water pill)
  • Medicine to treat depression
  • Medicine to treat migraine headaches
  • Phenothiazine medicine
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol. Tell your doctor if you are also using buprenorphine, butorphanol, nalbuphine, pentazocine, or a muscle relaxer.
• Do not drink alcohol while you are using this medicine.

Long Acting Capsule, Long Acting Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you. An overdose can be dangerous. Follow directions carefully so you do not get too much medicine at one time.
• Extended-release capsule:
  • It is best to take this medicine with food or milk.
  • Swallow the extended-release capsule whole. Do not crush, break, or chew it.
  • If you have trouble swallowing the capsule, you may open it and sprinkle the contents on soft foods (such as applesauce, pudding, ice cream, or jam) or into a cup. Eat the mixture or swallow the contents immediately. Drink a glass of water after you take the medicine to make sure you get a full dose.
• Extended-release tablet:
  • Swallow the extended-release tablet whole. Do not crush, break, or chew it. Do not take a tablet that is chipped or broken.
  • Do not soak, lick, or wet the tablet before you place it in your mouth. Take 1 tablet at a time with enough water to swallow it completely.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Store the medicine in a safe and secure place. Ask your pharmacist about the best way to dispose of medicine you do not use.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Oxycodone (ox-i-KOE-done)

Treats moderate to severe pain. This medicine is a narcotic pain reliever.

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, restlessness, fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, seeing or hearing things that are not there
• Blue lips, fingernails, or skin
• Extreme dizziness or weakness, shallow breathing, slow or uneven heartbeat, sweating, cold or clammy skin, seizures
• Lightheadedness, dizziness, fainting
• Severe constipation, stomach pain
• Trouble breathing or slow breathing

If you notice these less serious side effects, talk with your doctor:

• Mild constipation
• Mild sleepiness or tiredness

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, breathing problems or lung disease (such as asthma or COPD), low blood pressure, digestion problems, an enlarged prostate, gallbladder disease, pancreas disease, or trouble swallowing or urinating. Tell your doctor if you have a history of head injury, brain tumor, depression, seizures, or alcohol or drug addiction.
• This medicine may cause the following problems:
  • High risk of overdose, which can lead to death
  • Respiratory depression (serious breathing problem that can be life-threatening)
  • Serotonin syndrome, when used with certain medicines
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• This medicine may make you dizzy, drowsy, or faint. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Sit or lie down if you feel dizzy. Stand up carefully.
• This medicine may cause constipation, especially with long-term use. Ask your doctor if you should use a laxative to prevent and treat constipation.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

This medicine is not right for everyone. Do not use it if you had an allergic reaction to oxycodone or other narcotic medicine, or if you have a stomach or bowel blockage.