Information About Ultracet Prescriptions

IMPORTANT NOTE: The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

ACETAMINOPHEN; TRAMADOL

COMMON BRAND NAME(S): Ultracet

USES: Ultracet is used for pain relief.

HOW TO USE: Take acetaminophen; tramadol tablets by mouth. Follow the directions on the prescription label. Swallow the tablets with a drink of water. If acetaminophen; tramadol upsets your stomach, take it with food or milk. Do not take more than 2 tablets at a time or more than 8 tablets per day. Higher doses may cause severe side effects, do not take more medication than your prescriber has instructed.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

Older patients (> 60 years of age) may have a stronger reaction to this medicine, especially if they have kidney or liver disease.

ULTRACET SIDE EFFECTS: Side effects that you should report to your prescriber or health care professional as soon as possible:
Rare or uncommon:; changes in vision; difficulty breathing, shortness of breath; fast or irregular heartbeat; hallucinations (seeing and hearing things that are not really there); not passing urine as often as usual; redness, blistering, peeling or loosening of the skin, including inside the mouth; skin rash, itching; seizures (convulsions); yellow tint to your skin or whites of your eyes
More common:; anxiety, agitation; vomiting

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):; constipation or diarrhea; difficulty sleeping; dizziness, drowsiness; dry mouth; false sense of well being, feeling of unreality, mood changes; headache; indigestion; itching; nausea; sweating or flushing

PRECAUTIONS: Do not drive, use machinery, or do anything that needs mental alertness until you know how acetaminophen; tramadol affects you. Be careful taking other medicines which may also make you tired. This effect may be worse when taking these medicines with acetaminophen; tramadol. Alcohol can increase possible drowsiness, dizziness, confusion and affect your breathing. Do not drink alcoholic beverages while taking tramadol.

Your mouth may get dry. Chewing sugarless gum, sucking hard candy and drinking plenty of water will help.

If you are going to have surgery, tell your prescriber or health care professional that you are taking Ultracet(reg).

Many non-prescription medicines contain acetaminophen as an ingredient. Additional acetaminophen taken with Ultracet(reg) can be dangerous. Always read the labels carefully to avoid taking an accidental overdose of acetaminophen. Report any possible overdose of acetaminophen; tramadol promptly to your health care provider.

Acetaminophen can affect the results from some blood-sugar tests used by diabetic patients. Check with your prescriber or health care professional before you change your diet or the dose of your diabetic medicine.

DRUG INTERACTIONS: Tell your doctor of all prescription and nonprescription medications you may use, especially of: carbamazepine, narcotic pain relievers (e.g., codeine), drugs used to aid sleep, antidepressants (e.g., SSRI-types such as fluoxetine or fluvoxamine), MAO inhibitors (e.g., furazolidone, linezolid, phenelzine, procarbazine, selegiline, tranylcypromine), psychiatric medicine (e.g., nefazodone), "triptan"-type drugs, anti-anxiety drugs (e.g., diazepam), sibutramine. Also, report use of certain antihistamines (e.g., diphenhydramine) which are also present in many cough-and-cold products. Do not start or stop any medicine without doctor or pharmacist approval.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include cold and clammy skin, low body temperature, slowed breathing, slowed heartbeat, drowsiness, dizziness, lightheadedness, deep sleep, loss of consciousness, or seizures.

NOTES: Do not share this medication with others.

MISSED DOSE: If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

STORAGE: Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date. Keep this and all medications out of the reach of children.