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Oxycodone-Aspirin

Warning

Oxycodone/aspirin has a risk for abuse and addiction, which can lead to overdose and death. Oxycodone/aspirin may also cause severe, possibly fatal, breathing problems. To lower your risk, your doctor should have you take the smallest dose of oxycodone/aspirin that works, and take it for the shortest possible time. See also How to Use section for more information about addiction.

Ask your doctor or pharmacist if you should have naloxone available to treat opioid overdose. Teach your family or household members about the signs of an opioid overdose and how to treat it.

The risk for severe breathing problems is higher when you start this medication and after a dose increase, or if you take the wrong dose/strength. Taking this medication with alcohol or other drugs that can cause drowsiness or breathing problems may cause very serious side effects, including death. Also, other medications can affect the removal of oxycodone/aspirin from your body, which may affect how oxycodone/aspirin works. Be sure you know how to take oxycodone/aspirin and what other drugs you should avoid taking with it. See also Drug Interactions section. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up.

Keep this medicine in a safe place to prevent theft, misuse, or abuse. If someone accidentally swallows this drug, get medical help right away.

Precautions

Before taking oxycodone with aspirin, tell your doctor or pharmacist if you are allergic to it; or to other opioids (such as codeine, hydrocodone, oxymorphone), salicylates (such as salsalate), or nonsteroidal anti-inflammatory drugs (such as ibuprofen, naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: intestinal/bowel disorders (such as paralytic ileus, infectious diarrhea, colitis, blockage), kidney disease, liver disease, bleeding/blood-clotting disorders (such as hemophilia, vitamin K deficiency, low platelet count), stomach problems (such as ulcers, heartburn, stomach pain), gout, lung diseases (such as asthma, chronic obstructive pulmonary disease-COPD), breathing problems (such as slow/shallow breathing, sleep apnea), growths in the nose (nasal polyps), a certain spinal problem (kyphoscoliosis), certain heart problems (such as low blood pressure, irregular heartbeat), personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), brain disorders (such as seizures, head injury, tumor, increased intracranial pressure), underactive thyroid (hypothyroidism), difficulty urinating (for example, due to enlarged prostate or narrowed urethra), disease of the pancreas (such as pancreatitis), mental/mood disorders (such as toxic psychosis), gallbladder disease, adrenal gland problem (such as Addison's disease), certain enzyme deficiencies (pyruvate kinase or G6PD deficiency).

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially stomach/intestinal bleeding and ulcers, drowsiness, dizziness, slow/shallow breathing, confusion, difficulty urinating, and constipation.

This product contains aspirin. Children and teenagers less than 18 years old should not take aspirin if they have chickenpox, flu, or any undiagnosed illness, or if they have recently received a vaccine. In these cases, taking aspirin increases the risk of Reye's syndrome, a rare but serious illness.

Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks. Tell your doctor if you are pregnant or if you plan to become pregnant. This medication may harm an unborn baby and cause problems with normal labor/delivery. It is not recommended for use in pregnancy from 20 weeks until delivery. If your doctor decides that you need to use this medication between 20 and 30 weeks of pregnancy, you should use the lowest effective dose for the shortest possible time. You should not use this medication after 30 weeks of pregnancy.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.

Side Effects

See also Warning section.

Nausea, vomiting, upset stomach, constipation, dizziness, drowsiness, headache, increased sweating, dry mouth, lightheadedness, or weakness may occur. Some of these side effects may decrease after you have been using this medication for a while. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

To prevent constipation, eat dietary fiber, drink enough water, and exercise. You may also need to take a laxative. Ask your pharmacist which type of laxative is right for you.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: nausea that doesn't stop, interrupted breathing during sleep (sleep apnea), slow/fast/irregular heartbeat, mental/mood changes (such as depression, hallucinations, confusion), difficult/painful urination, ringing in the ears, decreased hearing, vision changes, easy bruising/bleeding, stomach/abdominal pain, black stools, vomit that looks like coffee grounds, yellowing eyes/skin, dark urine, signs of kidney problems (such as change in the amount of urine), signs of your adrenal glands not working well (such as loss of appetite, unusual tiredness, weight loss).

Get medical help right away if you have any very serious side effects, including: slow/shallow breathing, fainting, seizures, severe drowsiness/difficulty waking up.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever, swollen lymph nodes, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

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