"The the European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) will review the risks and benefits of modified- and prolonged-release paracetamol (acetaminophen) tablets, the agency said today.
(Generic versions may still be available.)
Products containing propoxyphene are used to relieve pain.
LIMIT YOUR INTAKE OF ALCOHOL WHILE TAKING THIS DRUG. Make sure your doctor knows if you are taking tranquilizers sleep aids, anti-depressants, antihistamines or any other drugs that make you sleepy. Combining propoxyphene with alcohol or these drugs in excessive doses is dangerous.
Use care while driving a car or using machines until you see how the drug affects you because propoxyphene can make you sleepy. Do not take more of the drug than your doctor prescribed. Dependence has occurred when patients have taken propoxyphene for a long period of time at doses greater than recommended.
The rest of this leaflet gives you more information about propoxyphene. Please read it and keep it for future use.
Uses of Propoxyphene
Products containing propoxyphene are used for the relief of mild to moderate pain. Products that contain propoxyphene plus aspirin or acetaminophen are prescribed for the relief of pain or pain associated with fever.
Before Taking Propoxyphene
Make sure your doctor knows if you have ever had an allergic reaction to propoxyphene, aspirin or acetaminophen. Some forms of propoxyphene products contain aspirin to help relieve the pain. Your doctor should be advised if you have a history of ulcers or if you are taking an anticoagulant (''blood thinner"). The aspirin may irritate the stomach lining and may cause bleeding particularly if an ulcer is present. Also bleeding may occur if you are taking an anticoagulant. In a small group of people aspirin may cause an asthma attack. If you are one of these people be sure your drug does not contain aspirin.
The effect of propoxyphene in children under 12 has not been studied. Therefore use of the drug in this age group is not recommended.
Also due to the possible association between aspirin and Reyes Syndrome, those propoxyphene products containing aspirin should not be given to children including teenagers, with chicken pox or flu unless prescribed by a physician. The following propoxyphene product contains aspirin: Propoxyphene Compound 65 mg Capsules (Propoxyphene Hydrochloride, Aspirin, and Caffeine, USP).
How to Take Propoxyphene
Follow your doctor's directions exactly. Do not increase the amount you take without your doctor's approval. If you miss a dose of the drug do not take twice as much the next time.
Do not take propoxyphene during pregnancy unless your doctor knows you are pregnant and specifically recommends its use. Cases of temporary dependence in the new-born have occurred when the mother has taken propoxyphene consistently in the weeks before delivery.
IT IS ESPECIALLY IMPORTANT NOT TO USE DARVON COMPOUND (propoxyphene, aspirin, and caffeine) -65 DURING THE LAST 3 MONTHS OF PREGNANCY UNLESS SPECIFICALLY DIRECTED TO DO SO BY A DOCTOR BECAUSE ASPIRIN MAY CAUSE PROBLEMS IN THE UNBORN CHILD OR COMPLICATIONS DURING DELIVERY.
As a general principle, no drug should be taken during pregnancy unless it is clearly necessary.
Heavy use of alcohol with propoxyphene is hazardous and may lead to overdosage symptoms (see Overdose below). THEREFORE LIMIT YOUR INTAKE OF ALCOHOL WHILE TAKING PROPOXYPHENE.
Combinations of excessive doses of propoxyphene, alcohol, and tranquilizers are dangerous. Make sure your doctor knows if you are taking tranquilizers, sleep aids, antidepressant drugs, antihistamines, or any other drugs that make YOU Sleepy. The use of these drugs with propoxyphene increases their sedative effects and may lead to Overdosage symptoms, including death (see Overdose below)
Propoxyphene may cause drowsiness or impair your mental and/or physical abilities; therefore, use caution when driving a vehicle. Do NOT perform any hazardous task until you have seen your response to this drug.
Propoxyphene may increase the concentration in the body of Medications such as anticoagulants ("blood thinners"), antidepressants, or drugs used for epilepsy. The result may be excessive or adverse effects of these medications. Make sure your doctor knows if you are taking any of these medications.
You can become dependent on propoxyphene if you take it in higher than recommended doses over a long period of time. Dependence is a feeling of need for the drug and a feeling that you cannot perform normally without it.
An overdose of propoxyphene, alone or in combination with other drugs, including alcohol, may cause weakness, difficulty in breathing, confusion, anxiety, and more severe drowsiness and dizziness. Extreme overdosage may lead to unconsciousness and death.
When the propoxyphene product contains aspirin, symptoms of taking too much of the drug are headache, dizziness, ringing in the ears, difficulty in hearing, dim vision, confusion, drowsiness, sweating, thirst, rapid breathing, nausea, vomiting, and occasionally, diarrhea.
In any suspected overdosage situation contact your doctor or nearest hospital emergency room. GET EMERGENCY HELP IMMEDIATELY.
KEEP THIS DRUG AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
Possible Side Effects
When propoxyphene is taken as directed, side effects are infrequent. Among those reported are drowsiness, dizziness, nausea, and vomiting. If these effects occur it may help if you lie down and rest.
Less frequently reported side effects are constipation, abdominal pain, skin rashes, lightheadedness, headache, weakness, hallucinations, minor visual disturbances, and feelings of elation or discomfort.
If side effects occur and concern you, contact your doctor.
The safe and effective use of propoxyphene depends on your taking it exactly as directed. This drug has been prescribed specifically for you and your present condition. Do not give this drug to others who may have similar symptoms. Do not use it for any other reason.
If you would like more information about propoxyphene, ask your doctor or pharmacist. They have a more technical leaflet (professional labeling) you may read.
Last reviewed on RxList: 1/29/2005
This monograph has been modified to include the generic and brand name in many instances.
Additional Darvon Compound Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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