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|Propoxyphene

Propoxyphene

Propoxyphene is used for:

Relieving mild to moderate pain.

Propoxyphene is a narcotic analgesic. It works in the brain to decrease pain.

Do NOT use Propoxyphene if:

• you are allergic to any ingredient in Propoxyphene
• you have severe diarrhea caused by antibiotic use (pseudomembranous colitis) or poisoning
• you are taking sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Propoxyphene :

Some medical conditions may interact with Propoxyphene . Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have prostate problems, liver problems (eg, hepatitis), or kidney problems
• if you have a history of drug abuse or dependence or depression or have ever seriously considered suicide
• if you have had a head injury, increased pressure in your brain, growths in your brain, or seizures
• if you have inflammatory bowel problems or ulcers, urinary problems, or you have had abdominal surgery
• if you have lung or breathing problems (eg, asthma), thyroid problems, heart problems, or certain blood problems (porphyria)

Some MEDICINES MAY INTERACT with Propoxyphene . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticoagulants (eg, warfarin) because side effects, including an increased risk of bleeding, may be increased by Propoxyphene
• Carbamazepine because the risk of severe side effects and toxicity, including nausea, vomiting, loss of coordination, and involuntary eye movements, may occur
• Antidepressant medicines (eg, amitriptyline, phenelzine), anticonvulsants (eg, phenobarbital, phenytoin), barbiturate anesthetics (eg, thiopental), cimetidine, HIV protease inhibitors (eg, ritonavir), and terfenadine because side effects may be increased by Propoxyphene
• Naltrexone because the effectiveness of Propoxyphene may be decreased
• Sodium oxybate (GHB) because side effects, including increased risk of sleep duration and drowsiness leading to unresponsiveness and coma, may be increased by Propoxyphene

This may not be a complete list of all interactions that may occur. Ask your health care provider if Propoxyphene may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Propoxyphene :

Use Propoxyphene as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Propoxyphene may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Propoxyphene comes with an additional patient leaflet. Read it carefully and reread it each time you get Propoxyphene refilled.
• Do not take more than your prescribed dose or take Propoxyphene for longer than prescribed by your health care provider.
• If you miss a dose of Propoxyphene and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Propoxyphene .

Important safety information:

• Propoxyphene may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Propoxyphene . Using Propoxyphene alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Use of alcohol with Propoxyphene may cause serious side effects. Limit your intake of alcohol while taking Propoxyphene . If you drink alcohol every day, do not take Propoxyphene without talking to your health care provider first. The combination of Propoxyphene and alcohol may cause liver damage.
• Make sure your health care provider knows if you are taking tranquilizers, sleep aids, antidepressant medicines, antihistamines, or any other medicines that may make you sleepy. The combination of these products with Propoxyphene may lead to serious side effects, including death.
• If you experience dizziness, drowsiness, nausea, or vomiting, it may help to lie down.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Propoxyphene .
• Propoxyphene may be habit-forming. Do not take more than the dose prescribed by your doctor or take Propoxyphene for a longer period of time than prescribed by your doctor.
• Use Propoxyphene with caution in the ELDERLY because they may be more sensitive to its effects.
• Use Propoxyphene with extreme caution in CHILDREN. Use of Propoxyphene is not recommended in CHILDREN younger than 12 years of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Propoxyphene during pregnancy. Propoxyphene is excreted in breast milk. If you are or will be breast-feeding while you are using Propoxyphene , check with your doctor or pharmacist to discuss the risks to your baby.

When used for long periods of time or at high doses, Propoxyphene may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Propoxyphene stops working well. Do not take more than prescribed.

Propoxyphene can cause DEPENDENCE if taken in higher doses than recommended by your health care provider or over a long period of time. Take Propoxyphene exactly as prescribed by your health care provider. If you suddenly stop taking Propoxyphene , you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goosebumps and abnormal skin sensations; nausea; pain; rapid heartbeat; rigid muscles; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; trouble sleeping; and vomiting.

Possible side effects of Propoxyphene :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; lightheadedness; nausea; vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety; cold or clammy skin; confusion; excessive sweating; hallucinations; loss of appetite; loss of consciousness; mental or mood changes; seizures; severe drowsiness or dizziness; severe or persistent stomach pain; vision changes; weakness; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include anxiety; confusion; dilated pupils; irregular heartbeat; muscle pain; severe drowsiness or dizziness; slow or difficult breathing; weakness.

Store Propoxyphene at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep Propoxyphene out of the reach of children and away from pets.

General information:

• If you have any questions about Propoxyphene , please talk with your doctor, pharmacist, or other health care provider.
• Propoxyphene is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Propoxyphene . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.