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WHAT IS ULTRACET, ULTRACET DRUG INFORMATION
COMMON BRAND NAME: ULTRACET®
Opioid analgesics affect the central nervous system (CNS) to relieve pain. Actions in the CNS also cause many of their side effects.
Using opioids for a long time causes your body may get used to them. Larger amounts are needed to relieve pain. This results in "tolerance" to the medicine. Opioids also become habit-forming when they are used for a long time or in large doses. Dependence may result in withdrawal symptoms when you stop taking them.
Acetaminophen is not habit-forming when taken for a long time. However, when taken in large doses, it may cause other unwanted side effects, including liver damage.
Ultracet is available only with a doctor's prescription, in the following dosage form:
Before deciding to use Ultracet, the risks of taking it must be weighed against the good it will do. This is a decision you need to make with your doctor.
For Ultracet (tramadol and acetaminophen in combination), the following should be considered:
Tell your health care professional if you have ever had any unusual or allergic reaction to acetaminophen, tramadol or other opioid analgesics. Also tell your doctor if you are allergic to any other substances, such as foods, dyes or preservatives.
Studies of Ultracet have only been done in adult patients. There is no specific information comparing use of tramadol and acetaminophen in children younger than 16 years of age as compared to other age groups.
Ultracet has been tested and has not been shown to cause any different side effects or problems in older adults than it does in younger adults.
ULTRACET and PREGNANCY
Ultracet has not been studied in pregnant women. Studies conducted with animals have shown that tramadol and acetaminophen combination causes birth defects and other problems. Before taking Ultracet, telll your doctor if you are pregnant or if you may become pregnant.
Using too much of an opioid during pregnancy may result in the fetus becoming dependent on the medicine. This may cause withdrawal side effects in the baby when it is born. The following have been reported:
ULTRACET and BREAST FEEDING
Tramadol and acetaminophen both pass into breast milk which may cause unwanted side effects in nursing babies. It may be necessary for you to change medicines or to stop breast-feeding if you continue with Ultracet. Discuss the risks and benefits of using Ultracet with your doctor.
ULTRACET DRUG INTERACTIONS
Certain drugs should not be used together at all. But other cases two different drugs may be used together even if an interaction might occur. In that case, your doctor may want to adjust your dose. Or other precautions may be necessary. When you are taking Ultracet, it is especially important that your doctor knows if you are taking any of the following:
TRAMADOL AND ACETAMINOPHEN IN COMBINATION (ULTRACET)
Products which contain acetaminophen (e.g., Tylenol, Chlor-Trimeton Sinus, Nyquil) -- Taking additional acetaminophen may cause an increase in the risk of liver problems.
OTHER MEDICAL PROBLEMS
If you have other medical problems, they may affect the use of Ultracet (tramadol and acetaminophen). Tell your doctor if you have any other medical problems, especially:
PROPER USE OF ULTRACET
Take Ultracet only as directed by your doctor or dentist. Do not take it more often, do not take more of it, and do not take it for a longer time than your doctor or dentist ordered. This is especially important for the elderly or young children, who may be more sensitive than others to the effects of analgesics. If too much analgesic is taken, the patient may become addicted (causing physical or mental dependence). It could also lead to medical problems because of an overdose.
Taking too much acetaminophen may cause liver damage.
The dose of Ultracet will be different for different patients. Follow your doctor's instructions or the directions on the prescription label. The following information includes only the average doses of Ultracet. Your prescribed dose may be different. Do not change it unless your doctor instructs you to do so.
The daily dose, the time between doses, and the length of time you take Ultracet depend on the medical problem for which you are taking it.
The analgesic in Ultracet will add to the effects of alcohol and other Central Nervous System (CNS) depressants (medicines which slow down your nervous system and can cause drowsiness). CNS depressants examples:
ALCOHOL -- There may be an increased risk of liver damage if you drink three or more alcoholic beverages while you are taking acetaminophen. Do not drink alcoholic beverages while you are using Ultracet.
Talk to your doctor or dentist before taking any of the medicines listed above, while you are using Ultracet.
Ultracet medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. Lying down for a while may also help relieve this side effect. Make sure you know how you react to Ultracet before you drive, use machines, or do anything else that could be dangerous if you are dizzy, drowsy, or not alert.
Getting up suddenly from a lying or sitting position may cause dizziness, lightheadedness, or fainting. Getting up slowly may help lessen this problem.
Vomiting or nausea may occur, especially after the first couple of doses. This side effect may go away if you lie down for a while. If vomiting or nausea continues, call your doctor or dentist.
Before having any kind of emergency treatment or surgery (this includes dental surgery), tell the medical doctor or dentist that you are taking Ultracet.
Analgesics may cause dryness of the mouth. For temporary relief, melt bits of ice in your mouth, use sugarless gum or candy, or use a saliva substitute. If dry mouth continues for more than 2 weeks, call your doctor or dentist. Continued dryness of the mouth increases the risk of dental disease, including gum disease, tooth decay, and fungal infections.
If you have been taking Ultracet regularly, do not suddenly stop taking it without first discussing it with your doctor. You may need to gradually reduce the amount you are taking before stopping completely. This will lessen the chance of withdrawal side effects. How you stop taking Ultracet will depend on the amount you have been taking every day.
ULTRACET SIDE EFFECTS
If any of these Ultracet side effects occur they may need medical attention. Call your doctor immediately if you experience any of the following:
Some Ultracet side affects are common, but do not usually need medical attention. As you body adjusts, these side effects may go away. However, if any of the following side effects continue or are bothersome, check with your doctor.
After you stop using Ultracet, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using, and how long you used it. During this time call your doctor if you notice any of the following side effects:
You may experience other side effects not listed above. If you notice any other side effects, check with your doctor.
If you suspect an overdose of Ultracet, get emergency help at once.
SYMPTOMS OF ULTRACET OVERDOSE
Keep Ultracet out of the reach of children. An overdose of tramadol and acetaminophen is very dangerous in young children.
Do not store Ultracet in the bathroom, near the kitchen sink, above the dishwasher or in other damp places heat or moisture may cause the medicine to break down.
Discard medicine that is outdated or no longer needed. Ask your pharmacist how you should dispose of any medicine you do not use. Make sure any discarded medicine is out of the reach of children.
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