What is the most important information I should know about acetaminophen and propoxyphene?

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Propoxyphene may be habit forming. Physical and/ or psychological dependence can occur, and withdrawal effects are possible if the medication is stopped suddenly after prolonged or high-dose treatment. Do not stop taking acetaminophen and propoxyphene suddenly without first talking to your doctor if you have been taking it continuously for more than 5 to 7 days. Your doctor may want to gradually reduce the dose.

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Do not take acetaminophen and propoxyphene if you suffer from depression or have suicidal thoughts.

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Do not take more of this medication than is prescribed. If the pain is not being adequately treated, talk to your doctor.

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Do not take other over-the-counter and prescription products that contain acetaminophen. Too much acetaminophen could be dangerous. Talk to your doctor or pharmacist before taking any over-the-counter preparations.

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Avoid alcohol while taking acetaminophen and propoxyphene. Alcohol can increase drowsiness and dizziness caused by the medication which could be dangerous. Also, alcohol may increase the risk of liver problems when taking acetaminophen.

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Drowsiness or dizziness caused by acetaminophen and propoxyphene may be increased by other drugs such as antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), other pain relievers, anxiety medicines, and muscle relaxants. Together, these medicines may cause dangerous sedation, possibly resulting in unconsciousness or death. Tell your doctor about all medicines that you are taking, and do not take any medicine without first talking to your doctor.

What is acetaminophen and propoxyphene?

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Propoxyphene (related to codeine) is in a class of drugs called narcotic analgesics. It works by changing the way the body feels pain.

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Acetaminophen is a less potent pain reliever that increases the effects of propoxyphene.

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Together, acetaminophen and propoxyphene are used to relieve pain.

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Acetaminophen and propoxyphene may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking acetaminophen and propoxyphene?

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Do not take acetaminophen and propoxyphene if you suffer from depression or have suicidal thoughts.

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Before taking this medication, tell your doctor if you have

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a history of drug or alcohol addiction;

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drink 3 or more alcoholic beverages per day;

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kidney disease;

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liver disease;

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asthma;

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urinary retention;

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an enlarged prostate;

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hypothyroidism;

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seizures or epilepsy;

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gallbladder disease;

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a head injury; or

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Addison's disease.

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You may not be able to take acetaminophen and propoxyphene, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

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Propoxyphene may cause addiction and withdrawal symptoms as well as other harmful effects in an unborn baby. Do not take acetaminophen and propoxyphene without first talking to your doctor if you are pregnant or could become pregnant during treatment.

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Propoxyphene may cause addiction and withdrawal symptoms in a nursing baby. Do not take acetaminophen and propoxyphene without first talking to your doctor if you are breast-feeding a baby.

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If you are younger than 18 years of age or older than 60 years of age, you may be more likely to experience side effects from acetaminophen and propoxyphene therapy. Your doctor may prescribe a lower dose.

How should I take acetaminophen and propoxyphene?

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Take acetaminophen and propoxyphene exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

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Take each dose with a full glass of water.

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Take acetaminophen and propoxyphene with food or milk if it upsets your stomach.

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Do not take more of this medication than is prescribed. If the pain is not being adequately treated, talk to your doctor.

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Propoxyphene may be habit forming. Physical and/ or psychological dependence can occur, and withdrawal effects are possible if the medication is stopped suddenly after prolonged or high-dose treatment. Do not stop taking acetaminophen and propoxyphene suddenly without first talking to your doctor if you have been taking it continuously for more than 5 to 7 days. Your doctor may want to gradually reduce the dose.

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Constipation may be a side effect of treatment with acetaminophen and propoxyphene. Increasing the amount of fiber and water (six to eight full glasses) in the diet may reduce constipation.

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Do not share this medication with anyone else.

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Store acetaminophen and propoxyphene at room temperature away from moisture and heat.

What happens if I miss a dose?

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Take the missed dose as soon as you remember. Do not take a double dose of this medication. Wait the prescribed amount of time before taking your next dose.

What happens if I overdose?

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Seek emergency medical attention if an overdose is suspected.

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Symptoms of a acetaminophen and propoxyphene overdose include slow breathing, seizures, dizziness, weakness, loss of consciousness, coma, confusion, tiredness, cold and clammy skin, small pupils, nausea, vomiting, and sweating.

What should I avoid while taking acetaminophen and propoxyphene?

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Avoid alcohol while taking acetaminophen and propoxyphene. Alcohol can increase drowsiness and dizziness caused by the medication which could be dangerous. Also, alcohol may increase the risk of liver problems when taking acetaminophen.

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Use caution when driving, operating machinery, or performing other hazardous activities. Acetaminophen and propoxyphene may cause drowsiness. If you experience drowsiness, avoid these activities.

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Do not take other over-the-counter and prescription products that contain acetaminophen. Too much acetaminophen could be dangerous. Talk to your doctor or pharmacist before taking any over-the-counter preparations.

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Drowsiness or dizziness caused by acetaminophen and propoxyphene may be increased by other drugs such as antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), other pain relievers, anxiety medicines, and muscle relaxants. Together, these medicines may cause dangerous sedation, possibly resulting in unconsciousness or death. Tell your doctor about all medicines that you are taking, and do not take any medicine without first talking to your doctor.

What are the possible side effects of acetaminophen and propoxyphene?

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If you experience any of the following serious side effects, stop taking acetaminophen and propoxyphene and seek emergency medical attention:

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an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

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slow, weak breathing;

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seizures;

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cold, clammy skin;

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severe weakness or dizziness;

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unconsciousness;

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yellowing of the skin or eyes; or

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unusual fatigue, bleeding, or bruising.

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Other, less serious side effects may be more likely to occur. Continue to take acetaminophen and propoxyphene and talk to your doctor if you experience

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constipation;

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dry mouth, nausea, vomiting, or decreased appetite;

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dizziness, tiredness, or lightheadedness;

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muscle twitches;

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sweating;

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itching;

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decreased urination; or

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decreased sex drive.

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Propoxyphene may be habit forming. Physical and/ or psychological dependence can occur, and withdrawal effects are possible if the medication is stopped suddenly after prolonged or high-dose treatment. Do not stop taking acetaminophen and propoxyphene suddenly without first talking to your doctor if you have been taking it continuously for more than 5 to 7 days. Your doctor may want to gradually reduce the dose.

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Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect acetaminophen and propoxyphene?

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Do not take acetaminophen and propoxyphene if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. Dangerous side effects could result.

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Propoxyphene may increase the effects of oral anticoagulants such as warfarin (Coumadin) which could lead to bleeding. It may also increase the effects of carbamazepine (Tegretol) leading to toxicity. Be sure your doctor is aware if you are taking either of these medications.

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Drowsiness or dizziness caused by acetaminophen and propoxyphene may be increased by other drugs such as antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), other pain relievers, anxiety medicines, and muscle relaxants. Together, these medicines may cause dangerous sedation, possibly resulting in unconsciousness or death. Tell your doctor about all medicines that you are taking, and do not take any medicine without first talking to your doctor.

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Drugs other than those listed here may also interact with acetaminophen and propoxyphene. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

Where can I get more information?

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Your pharmacist has additional information about acetaminophen and propoxyphene written for health professionals that you may read.

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Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.