Roxicodone (Oxycodone Concentrate)

• Tell all of your health care providers that you take Roxicodone. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
• Do not take Roxicodone (oxycodone concentrate) with other strong pain drugs or if you are using a pain patch without talking to your doctor first.
• Do not switch between different forms of this medicine without first talking with the doctor.
• Long-term use of an opioid drug like Roxicodone may lead to lower sex hormone levels. This may lead to signs like change in sex ability in men, no menstrual period in women, lowered interest in sex, or fertility problems. Call your doctor if you have any of these signs.
• If you have been taking this medicine for a long time or at high doses, it may not work as well and you may need higher doses to get the same effect. This is known as tolerance. Call your doctor if Roxicodone stops working well. Do not take more than ordered.
• If you have been taking this medicine on a regular basis and you stop it all of a sudden, you may have signs of withdrawal. Do not stop taking Roxicodone all of a sudden without calling your doctor. Tell your doctor if you have any bad effects.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking Roxicodone, call your doctor right away.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take by mouth only.
• Do not inject or snort Roxicodone. Doing any of these things can cause very bad side effects like trouble breathing and death from overdose.
• Measure liquid doses carefully. Use the measuring device that comes with this medicine.

What do I do if I miss a dose?

• If you take Roxicodone on a regular basis, take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• Many times this medicine is taken on an as needed basis. Do not take more often than told by the doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.
• Hard stools (constipation).
• Dizziness.
• Feeling sleepy.
• Headache.
• Not able to sleep.
• Feeling tired or weak.
• Itching.
• Dry mouth.
• Belly pain.
• Loose stools (diarrhea).
• Not hungry.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.