ASPIRIN/CAFFEINE/PROPOXYPHENE

(AS pir in/CAF feen/proe POX ih feen) Brand: Darvon Compound 32, Darvon Compound-65, PC-CAP, Propoxyphene Compound 65

What is the most significant information I must know about aspirin/caffeine/propoxyphene?

Propoxyphene may be habit forming. Physical and/or psychological dependency can occur, and withdrawal effects are possible if the medicine is stopped suddenly after prolonged or high-dose treatment. Do not stop taking aspirin/caffeine/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.

• Avoid alcohol while taking aspirin/caffeine/propoxyphene. Alcohol can magnify drowsiness and dizziness caused by the medicine which could be dangerous. Also, alcohol increases the risk of stomach bleeding when taking aspirin.

• Do not take more of this medicine than is predesigned. If the pain is not being adequately treated, conversation to your doctor.

• Do not take another over-the-counter and prescription commodity that contain aspirin. Too many aspirin could be dangerous. Conversation to your doctor or pharmacist till taking any over-the-counter preparations.

• Drowsiness or dizziness caused by aspirin/caffeine/propoxyphene may be heighten by another drugs such as antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), another pain relievers, anxiety medicines, and muscle relaxants. Together, these medicines may reason dangerous sedation, possibly resulting in unconsciousness or death. Speak your doctor about all medicines that you are taking, and do not take any medication without first talking to your doctor.

What is aspirin/caffeine/propoxyphene?

Propoxyphene (related to codeine) is in a class of drugs called narcotic analgesics. It relieves pain.

Aspirin is a smaller potent pain reliever, as well as an anti-inflammatory and a fever reducer. Aspirin increases the effects of propoxyphene.

Caffeine constricts blood vessels. This is believed to help relieve tension headaches by constricting dilated blood vessels in the head.

• The combination, aspirin/caffeine/propoxyphene, is used to treat moderate-to-severe pain.

Aspirin/caffeine/propoxyphene may also be used for purposes another than those listed in this medicine guide.

What must I discuss with my healthcare provider till taking aspirin/caffeine/propoxyphene?

• Till taking this medicine, speak your doctor if you have

· kidney disease;

· liver disease;

· a bleeding or blood clotting disorder;

· a stomach ulcer;

· asthma;

· urinary retention;

· an enlarged prostate;

· hypothyroidism;

· seizures or epilepsy;

· gallbladder disease;

· a head injury;

· Addison's malady; or

· a history of drug or alcohol addiction.

• You may not be able to take aspirin/caffeine/propoxyphene, or you may require a dosage adjustment or particular monitoring during treatment if you have any of the conditions listed above.

Propoxyphene may reason addiction and withdrawal symptoms as well as another deleterious effects in an unborn child. Do not take aspirin/caffeine/propoxyphene without first talking to your doctor if you are pregnant or could become pregnant during treatment.

Propoxyphene may also reason addiction and withdrawal symptoms in a nursing child. Do not take aspirin/caffeine/propoxyphene without first talking to your doctor if you are breast-feeding a baby.

• If you are older than 60 years of age, you may be more likely to experience side effects from this therapy. Your doctor may prescribe a lower doze of the medication.

• Do not use any product that contains aspirin to treat a baby or teenager who has a fever, flu symptoms, or chicken pox without first talking to a doctor. In children younger than 20 years of age, aspirin may magnify the risk of Reye's syndrome, a rare but often fatal condition.

How must I take aspirin/caffeine/propoxyphene?

• Take aspirin/caffeine/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.

• Take every doze with a full glass of water.

Aspirin/caffeine/propoxyphene can be taken with food or milk if it causes stomach upset.

• Do not take more of this medicine than is predesigned. If the pain is not being adequately treated, conversation to your doctor.

Propoxyphene may be habit forming. Physical and/or psychological dependency can occur, and withdrawal effects are possible if the medicine is stopped suddenly after prolonged or high-dose treatment. Do not stop taking aspirin/caffeine/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.

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

• Do not share this medicine with anyone else.

• Store aspirin/caffeine/propoxyphene at room temperature away from moisture and heat.

What happens if I miss a dose?

• Take the missed doze as soon as you remember. Do not take a double doze of this medicine. Wait the predesigned amount of time till taking the following dose.

What happens if I overdose?

• Search abnormal medical attention if an overdose is suspected.

• Symptoms of an aspirin/caffeine/propoxyphene overdose include slow breathing, seizures, dizziness, weakness, loss of consciousness, coma, confusion, tiredness, cool and clammy skin, little pupils, nausea, vomiting, ringing in the ears, and sweating.

What must I avoid while taking aspirin/caffeine/propoxyphene?

• Avoid alcohol while taking aspirin/caffeine/propoxyphene. Alcohol can magnify drowsiness and dizziness caused by the medicine which could be dangerous. Also, alcohol increases the risk of stomach bleeding when taking aspirin.

• Use caution when driving, operating machinery, or performing another hazardous activities. Propoxyphene may reason drowsiness. If you experience drowsiness, avoid these activities.

• Do not take another over-the-counter and prescription commodity that contain aspirin. Too many aspirin could be dangerous. Conversation to your doctor or pharmacist till taking any over-the-counter preparations.

• Drowsiness or dizziness caused by aspirin/caffeine/propoxyphene may be heighten by another drugs such as antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), another pain relievers, anxiety medicines, and muscle relaxants. Together, these medicines may reason dangerous sedation, possibly resulting in unconsciousness or death. Speak your doctor about all medicines that you are taking, and do not take any medication without first talking to your doctor.

What are the possible side effects of aspirin/caffeine/propoxyphene?

• If you experience any of the next serious side effects, stop taking aspirin/caffeine/propoxyphene and search abnormal medical attention or contact your doctor immediately:

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

· slow, weak breathing;

· seizures;

· cool, clammy skin;

· severe weakness or dizziness;

· unconsciousness; or

· black, bloody, or tarry stools or blood in your urine or vomit.

• Another, smaller serious side effects may be more likely to occur. Continue to take aspirin/caffeine/propoxyphene and conversation to your doctor if you experience

· constipation;

· dry mouth, nausea, vomiting, or decreased appetite;

· dizziness, tiredness, or lightheadedness;

· muscle twitches;

· sweating;

· itching

· decreased urination;

· decreased sex drive; or

· ringing in the ears.

Propoxyphene may be habit forming. Physical and/or psychological dependency can occur, and withdrawal effects are possible if the medicine is stopped suddenly after prolonged or high-dose treatment. Do not stop taking aspirin/caffeine/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.

• Side effects another than those listed here may also occur. Conversation to your doctor about any side effect that seems unusual or that is especially bothersome. You may message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect aspirin/caffeine/propoxyphene?

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

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

• Drowsiness or dizziness caused by aspirin/caffeine/propoxyphene may be heighten by another drugs such as antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), another pain relievers, anxiety medicines, and muscle relaxants. Together, these medicines may reason dangerous sedation, possibly resulting in unconsciousness or death. Speak your doctor about all medicines that you are taking, and do not take any medication without first talking to your doctor.

• Do not take another over-the-counter and prescription commodity that contain aspirin. Too many aspirin could be dangerous. Conversation to your doctor or pharmacist till taking any over-the-counter preparations.

• Drugs another than those listed here may also interact with aspirin/caffeine/propoxyphene. Conversation to your doctor and pharmacist till taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

Where can I get more information?

• Your pharmacist has additional information about aspirin/caffeine/propoxyphene written for health professionals that you may read.

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses external of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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