Oxecta is an opioid pain medication. An opioid is sometimes called a narcotic.

Oxecta is an immediate release tablet used to treat moderate to severe pain.

Oxecta may also be used for purposes not listed in this medication guide.

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

Oxecta can slow or stop your breathing, especially when you start using this medicine or whenever your dose is changed. Never take this medicine in larger amounts, or for longer than prescribed.

Oxecta may be habit-forming, even at regular doses. Take this medicine exactly as prescribed by your doctor. Never share the medicine with another person. MISUSE OF NARCOTIC PAIN MEDICATION 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.

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with oxycodone.

Oxecta can cause severe constipation. Laxatives and/or stool softeners should be used in conjuction with this medicine.

Before using Oxecta

You should not use Oxecta if you are allergic to oxycodone, or if you have:

• severe asthma or breathing problems;

• a blockage in your stomach or intestines; or

• an allergy to any narcotic pain medicine (such as methadone, morphine, Percocet, Vicodin, Lortab, and many others), or narcotic cough medicine that contains codeine, hydrocodone, or dihydrocodeine.

You should not use oxycodone unless you are already using a similar opioid medicine and are tolerant to it. Ask your doctor if you are not sure you are opioid-tolerant.

Oxecta may be habit forming. 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. Selling or giving away Oxecta to any other person is against the law.

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 Oxecta 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;

• Addison's disease or other adrenal gland disorder; or

• problems with your gallbladder, pancreas, or thyroid.

Tell your doctor if you are pregnant. If you use Oxecta 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.

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

Do not give this medicine to a child without medical advice.

Take Oxecta exactly as prescribed. Follow all directions on your prescription label. Oxecta can slow or stop your breathing, especially when you start using this medicine or whenever your dose is changed. Never take in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Take each tablet with enough water to ensure complete swallowing immediately after placing the tablet in the mouth. Oxecta tablets must be swallowed whole. Do not crush or dissolve.

Do not pre-soak, lick or otherwise wet the Oxecta tablet prior to placing in the mouth.

Oxycodone may be habit-forming, even at regular doses. Take this medicine exactly as prescribed by your doctor. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH.

Do not stop using oxycodone suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using this medicine.

Never crush or break an Oxecta tablet to inhale the powder or mix it into a liquid to inject the drug into your vein. This practice has resulted in death with the misuse of oxycodone and similar prescription drugs.

Store Oxecta at room temperature, away from heat, moisture, and light.

Keep track of the amount of medicine used from each new bottle. Oxycodone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Always check your bottle to make sure you have received the correct pills (same brand and type) of medicine prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine you receive at the pharmacy.

Do not keep leftover Oxecta tablets. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush any unused tablets down the toilet. Disposal of medicines by flushing is recommended to reduce the danger of accidental overdose causing death. This advice applies to a very small number of medicines only. The FDA, working with the manufacturer, has determined this method to be the most appropriate route of disposal and presents the least risk to human safety.

You should not use Oxecta if you are allergic to oxycodone, or if you have:

• severe asthma or breathing problems;

• a blockage in your stomach or intestines; or

• an allergy to any narcotic pain medicine (such as methadone, morphine, Percocet, Vicodin, Lortab, and many others), or narcotic cough medicine that contains codeine, hydrocodone, or dihydrocodeine.

You should not use oxycodone unless you are already using a similar opioid medicine and are tolerant to it. Ask your doctor if you are not sure you are opioid-tolerant.

Oxecta may be habit forming. 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. Selling or giving away Oxecta to any other person is against the law.

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 Oxecta 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;

• Addison's disease or other adrenal gland disorder; or

• problems with your gallbladder, pancreas, or thyroid.

Tell your doctor if you are pregnant. If you use Oxecta 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.

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

Do not give this medicine to a child without medical advice.

Since Oxecta is used when needed, you may not be on a dosing schedule. If you are on a schedule and you miss a dose, take it as soon as possible. If it is almost time for the next dose, skip the missed dose and take the next dose at the regularly scheduled time. Do not take 2 doses at once unless instructed by your healthcare provider. If you are not sure call your healthcare provider.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An oxycodone overdose can be fatal, especially in a child or other person using the medicine without a prescription.

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with Oxecta. Check your food and medicine labels to be sure these products do not contain alcohol.

Oxecta may impair your thinking or reactions. Avoid driving or operating machinery until you know how you are affected. Dizziness or severe drowsiness can cause falls or other accidents.

Grapefruit and grapefruit juice may interact with Oxecta and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

Get emergency medical help if you have any signs of an allergic reaction to Oxecta: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

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

• seizure (convulsions);

• confusion, severe drowsiness;

• infertility, missed menstrual periods;

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

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

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

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

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.

Common Oxecta side effects may include:

• drowsiness, headache, dizziness, tired feeling;

• stomach pain, nausea, vomiting, constipation, loss of appetite;

• dry mouth; or

• mild itching.

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.

Some medicines can cause unwanted or dangerous effects when used with oxycodone. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.

Taking this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking Oxecta with a sleeping pill, muscle relaxer, other pain medicine, or medicine for anxiety, depression, or seizures.

Other drugs may interact with oxycodone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.