Wygesic Oral

FDA and Health Canada have requested that manufacturers voluntarily withdraw propoxyphene-containing medications from the US and Canadian markets due to several problems with safety, and its limited effectiveness.
This combination medication is used to treat mild to moderate pain. Propoxyphene is a narcotic pain reliever (opiate-type) that acts on certain centers in the brain to give you pain relief. Acetaminophen is a non-narcotic pain reliever.

How to use Wygesic Oral
See also Warning section.
Take this medication by mouth as directed by your doctor. It may be taken with food if stomach upset occurs, however, the drug may not work as well. Consult your doctor or pharmacist about other ways to reduce stomach upset (e.g., antihistamines, lying down for 1-2 hours with minimal head movement).
Dosage is based on your medical condition and response to therapy. Pain medications work best if used when the first signs of pain occur. If you wait until the pain worsens, the medication may not work as well.
Use this medication exactly as prescribed. Do not exceed the maximum daily dose of propoxyphene hydrochloride (390 milligrams per day).
Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor instructs you otherwise. Grapefruit can increase the amount of this medication in your bloodstream. Consult your doctor or pharmacist for more details.
Do not increase your dose, take it more often or use it longer than prescribed because it can be habit-forming. If this drug is prescribed for an extended period of time, do not suddenly stop using it without your doctor\'s approval.
When used for an extended period, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well.
Inform your doctor if your pain persists or worsens.

See also Warning section.
Nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, headache, or vision changes may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these serious side effects occur: mental/mood changes.
Tell your doctor immediately if this highly unlikely but very serious side effect occurs: change in the amount of urine.
Get medical help right away if any of these rare but serious side effects occur: fast/irregular heartbeat, severe dizziness, fainting.
A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.
Before taking propoxyphene with acetaminophen, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: abdominal/stomach problems (e.g., severe diarrhea), alcohol use, breathing or lung disease (e.g., asthma, chronic obstructive pulmonary disease), difficulty urinating (e.g., enlarged prostate, urethral stricture), drug dependency, kidney disease, liver disease, mental/mood problems (e.g., depression, suicidal tendency, toxic psychosis), seizure disorders, serious head injury or brain disease.
This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.
This medication may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm. Before using this medication, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG, heart block), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).
Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/\"water pills\") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using this medication safely.
To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position.
Caution is advised when using this drug in the elderly because they may be more sensitive its side effects, especially drowsiness.
Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, take the smallest effective dose for the shortest possible time. Tell the doctor right away if you notice any symptoms in your newborn baby such as slow/shallow breathing, irritability, abnormal/persistent crying, vomiting, or diarrhea.
Propoxyphene with acetaminophen passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.

See also Warning section.
Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.
This drug should not be used with the following medication because very serious interactions may occur: naltrexone.
If you are currently using this medication, tell your doctor or pharmacist before starting propoxyphene/acetaminophen.
Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: \"blood thinners\" (e.g., warfarin), carbamazepine, cimetidine, MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine), other pain medications, tricyclic antidepressants (e.g., doxepin).
The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also affect breathing or cause drowsiness. Therefore, tell your doctor or pharmacist if you are taking other products such as alcohol, medicine for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and other narcotic pain relievers (such as codeine).
Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about the safe use of those products.
This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include slow/shallow breathing, slow heartbeat, loss of consciousness, seizures, severe nausea/vomiting/stomach pain, cold/clammy skin, unusual sweating.

NOTES:
Medical tests (such as EKG) should be performed periodically to check for side effects. Consult your doctor for more details.
Do not share this medication with others. It is against the law.
This medication has been prescribed for your current condition only. Do not use it later for other conditions unless directed by your doctor. A different medication may be necessary in those cases.
To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative (e.g., stimulant-type).

MISSED DOSE:
If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE:
Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised October 2011. Copyright(c) 2011 First Databank, Inc.