Targiniq ER

You should not use Targiniq ER if you have severe asthma or breathing problems, severe liver disease, or a blockage in your stomach or intestines.

Oxycodone can slow or stop your breathing. Never use this medicine in larger amounts, or for longer than prescribed. Swallow the tablet whole to avoid exposure to a potentially fatal dose. Targiniq ER may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Tell your doctor if you are pregnant. Oxycodone may cause life-threatening withdrawal symptoms in a newborn if the mother has taken this medicine during pregnancy.

Some medicines can interact with naloxone and oxycodone, and cause dangerous side effects or death. Tell your doctor about all your current medicines and any you start or stop using.

Do not drink alcohol. Dangerous side effects or death could occur.

You should not use Targiniq ER if you are allergic to naloxone or oxycodone, or if you have:

• severe asthma or breathing problems;

• severe liver disease; or

• a blockage in your stomach or intestines.

Some medicines can interact with oxycodone and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

To make sure Targiniq ER is safe for you, tell your doctor if you have:

• any type of breathing problem or lung disease;

• a history of head injury, brain tumor, or seizures;

• a history of drug abuse, alcohol addiction, or mental illness;

• urination problems;

• liver or kidney disease;

• heart disease;

• problems with your gallbladder, pancreas, or thyroid; or

• if you use a sedative like Valium (diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others).

It is not known whether Targiniq ER will harm an unborn baby. If you use this medicine while you are pregnant, your baby could become dependent on oxycodone. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

Oxycodone can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using Targiniq ER.

Get emergency medical help if you have any of these signs of an allergic reaction to Targiniq ER: hives; feeling light-headed; chest pain, fast heartbeats, difficult breathing; swelling of your face, lips, tongue, or throat.

Like other narcotic medicines, oxycodone can slow your breathing. Death may occur if breathing becomes too weak.

Call your doctor at once if you have:

• shallow breathing, slow heartbeat, cold, clammy skin;

• seizure (convulsions);

• confusion, severe drowsiness;

• a light-headed feeling, like you might pass out;

• infertility, missed menstrual periods;

• impotence, sexual problems, loss of interest in sex; or

• low cortisol levels - nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Targiniq ER is more likely to cause breathing problems in older adults and people who are severely ill, malnourished, or otherwise debilitated.

Common Targiniq ER side effects may include:

• drowsiness, headache, dizziness;

• stomach pain, nausea, constipation;

• anxiety; or

• sweating.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can raise or lower your blood levels of oxycodone, which may cause side effects or make oxycodone less effective. Oxycodone can also affect blood levels of certain other drugs, making them less effective or increasing side effects.

Narcotic (opioid) medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• other narcotic medications - opioid pain medicine or prescription cough medicine;

• drugs that make you sleepy or slow your breathing - a sleeping pill, muscle relaxer, sedative, tranquilizer, or antipsychotic medicine; or

• drugs that affect serotonin levels in your body - medicine for depression, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting.

This list is not complete. Other drugs may interact with naloxone and oxycodone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.