Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

PROPOXYPHENE/ASPIRIN/CAFFEINE - ORAL

(pro-POX-ee-feen/ASP-er-in/kaff-EEN)

COMMON BRAND NAME(S): Darvon Cmpd-65, PC-Cap 65

WARNING: Children and teenagers should not use aspirin, aspirin- containing or aspirin-related medications for flu symptoms or chickenpox without first consulting a doctor. A rare but serious illness known as Reye's syndrome may occur. Propoxyphene should be used with extreme caution, if at all, in people who use alcohol; have a history of substance abuse or emotional conditions; or who already take drowsiness-causing drugs (e.g., antidepressants, barbiturates, muscle relaxants, pain relievers, sedatives). Fatalities have occurred in such patients when propoxyphene was misused.

Uses

This medication is used to relieve moderate to severe pain and swelling (inflammation).

How To Use

To prevent upset stomach, take with food or milk. Take this medication with a full glass (8 oz or 240 ml) of water unless your doctor directs you otherwise. Do not lie down for at least 30 minutes after taking this drug. Pain medications work best in preventing pain before it occurs. Once the pain becomes intense, this medication may not be as effective in relieving the pain. Use this medication exactly as directed by your doctor. Do not increase your dose, use it more frequently or use it for a longer period of time than prescribed because this drug can be habit-forming. Also, if used for an extended period, do not suddenly stop using this drug without your doctor's approval. Over time, this drug may not work as well. Consult your doctor if this medication is not relieving the pain sufficiently.

Side Effects

May cause constipation, lightheadedness, dizziness, drowsiness, stomach upset, nausea, or flushing the first few days as your body adjusts to the medication. If these symptoms persist or become bothersome, inform your doctor. Notify your doctor if you develop: irregular heartbeat, ringing in the ears, anxiety, tremors. In the unlikely event you have an allergic reaction to this drug, seek immediate medical attention. Symptoms of an allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

Tell your doctor your medical history, especially of: asthma, anemia, bleeding problems, ulcers, gout, any drug allergies, substance abuse history, emotional or mental problems, liver or heart problems, breathing problems, high blood pressure, severe diarrhea. This combination product contains aspirin. Children and teenagers should not take aspirin if they have chickenpox, influenza or any undiagnosed illness without first consulting a doctor about Reye's syndrome, a rare but serious illness. This medicine may cause stomach bleeding. Daily use of alcohol, especially when combined with this medicine, may increase your risk for stomach bleeding. Check with your doctor or pharmacist for more information. Use caution engaging in activities requiring alertness such as driving or using machinery. Avoid alcoholic beverages. Aspirin is not recommended for use during pregnancy. Consult your doctor before using this drug. This drug is excreted into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before you breast-feed.

Drug Interactions

Tell your doctor of all medications you may use (both prescription and nonprescription), especially of: warfarin, cimetidine, acetazolamide, other narcotic pain drugs, corticosteroids, methotrexate, arthritis drugs, gout drugs, drugs used for diabetes. Also report the use of medicines that make you drowsy, such as: sleeping pills, sedatives, anti-anxiety drugs (e.g., diazepam), anti-seizure drugs, muscle relaxants, tranquilizers, psychiatric drugs (e.g., antidepressants), certain antihistamines (e.g., diphenhydramine). Because this medication contains aspirin, check with your doctor or pharmacist before taking other medications containing pain relievers. Pain relievers can be found in many cough-and-cold preparations. This medication contains caffeine. Avoid drinking large amounts of caffeinated beverages while taking this medication as excessive nervousness and irritability can occur. Do not start or stop any medicine without doctor or pharmacist approval.

Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include slow and shallow breathing, unusual sleepiness, dizziness, decreased pupil size, cold and clammy skin, difficulty hearing, ringing in the ears, headache, sweating, thirst, nausea, vomiting, and loss of consciousness.

Notes

To prevent constipation, increase your intake of fiber, drink plenty of water and exercise. Do not allow anyone else to take this medication.

Missed Dose

If you miss a dose, take it as soon as remembered; do not take if it is almost time for the next dose, instead, skip the missed dose and resume your usual dosing schedule. Do not "double-up" the dose to catch up.

Storage

Store at room temperature away from moisture and sunlight. Do not store in the bathroom.