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ESGIC PLUS GENERIC DRUG INFORMATION, ABOUT ESGIC PLUS
WHAT IS ESGIC PLUS?
Butalbital (byoo-TAL-bi-tal) and acetaminophen (a-seat-a-MIN-oh-fen) combination is a relaxant and pain reliever. It is used to treat tension headaches. Butalbital belongs to the group of medicines which are called barbiturates (bar-BI-tyoo-rates). Barbiturates act in the central nervous system (CNS).
When butalbital is taken for a long time, your body may become used to it so that larger amounts are needed to produce the same effects. The term for this is tolerance to the medication. Also, when butalbital is used for a long time or in large doses it may become habit-forming (causing mental or physical dependence). Physical dependence may lead to withdrawal side effects when the medicine is stopped. In patients who get headaches, the first withdrawal symptom may be new (rebound) headaches.
Some butalbital and acetaminophen combinations also contain caffeine. Caffeine may help to relieve headaches. However, your body can become physically dependant when caffeine is used for a long time. This may then lead to withdrawal (rebound) headaches when you stop taking it.
Additionally, a butalbital and acetaminophen combination may be used for other kinds of headaches or other kinds of pain as determined by your physician.
Butalbital and acetaminophen combinations are available only with your physician's prescription in the following dosage forms:
BEFORE USING ESGIC PLUS:
When deciding to use a medicine, the risks of taking it must be weighed against the good it will do. This is a decision you and your physician will make together. For butalbital and acetaminophen combinations, the following should be considered:
Tell your physician if you have ever had any unusual or allergic reaction to butalbital or any other barbiturate, or to aspirin, acetaminophen, or caffeine. Also tell your physician if you are allergic to any other substances, such as foods, dyes or preservatives.
ESGIC PLUS and PREGNANCY
For butalbital: Barbiturates such as butalbital have been shown to increase the chance of birth defects. Also, one study has suggested that barbiturates taken during pregnancy may increase the chance of brain tumors developing in the baby. Butalbital may cause breathing problems in the newborn if taken just before or during delivery.
For acetaminophen: Studies on birth defects with acetaminophen have not been done in pregnant women, however, it has not been reported to cause birth defects or other problems.
For caffeine: Studies have not shown that caffeine, which is contained in some of these combination medicine, causes birth defects. However, consumption of large amounts of caffeine during pregnancy may cause problems with the heart rhythm and the growth of the fetus. Additionally, studies in animals have shown that caffeine causes birth defects when given in very large doses, that is, in amounts equal to those present in 12 to 24 cups of coffee a day.
ESGIC PLUS and BREAST FEEDING
For butalbital: Barbiturates such as butalbital will pass into breast milk and may cause unusually slow heartbeat, drowsiness, shortness of breath, or difficult breathing in nursing babies.
For acetaminophen: Although acetaminophen has not been shown to cause problems in nursing babies, it does passes into the breast milk in small amounts./p>
For caffeine: Caffeine, which is present in some butalbital and acetaminophen combinations, passes into the breast milk in small amounts. Ingesting caffeine in the amounts present in these medicines has not been shown to cause problems in nursing babies. However, studies have shown that nursing babies may appear jittery and have trouble in sleeping if their mother drinks large amounts of beverages containing caffeine. Therefore, breast-feeding mothers who use medicines which contain caffeine should limit the amount of caffeine they consume from other medicines or from beverages.
For butalbital: Although barbiturates such as butalbital often cause drowsiness, some children will become excited after taking them.
For acetaminophen: Acetaminophen has been tested in children and has not been shown to cause different side effects or problems than it does in adults when used in effective doses.
For caffeine: There have been no studies comparing the use of caffeine in children up to 12 years of age with use in other age groups. However, caffeine is not expected to cause different problems or side effects in children than it does in adults.
For butalbital: Certain side effects, such as excitement, confusion or mental depression, may be more likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of the butalbital in this combination medicine.
For acetaminophen: Studies have not shown that acetaminophen causes different side effects or problems in older people than it does in younger adults.
For caffeine: There is no specific information comparing use of caffeine in the elderly with use in other age groups.
ESGIC PLUS DRUG INTERACTIONS
Although certain medications should never be used together, in other cases two medicines may be used together even if an interaction might occur. In these cases, your physician may want to change the dose, or other precautions may be necessary. When you are taking butalbital and acetaminophen in combination, it is especially important that your physician know if you are taking any of the following:
OTHER MEDICAL PROBLEMS
The presence of other medical problems may affect the use of butalbital and acetaminophen combinations. Make sure you tell your doctor about any other medical problems, especially:
A butalbital dependence may develop. Also, acetaminophen use may result in liver damage in people who abuse alcohol.
The chance of serious side effects may be increased
Butalbital can make these conditions worse
The caffeine found in some butalbital and acetaminophen combinations can make some kinds of heart conditions worse.
PROPER USE OF ESGIC PLUS
Take Esgic Plus only as directed by your doctor. Do not take more, do not take more often and do not take for a longer time than your physician ordered. If a butalbital and acetaminophen combination is taken regularly, it may become habit-forming (causing mental or physical dependence). The caffeine found in some butalbital and acetaminophen combinations can also increase the chance of dependence. Dependence is likely to occur in patients who take these medications to relieve frequent headaches. Taking too much of Esgic Plus may also lead to liver damage or other medical problems.
Esgic Plus will relieve a headache best if you take it as soon as the headache begins. If you have warning signs of a migraine, take it as soon as you are sure that the migraine is coming. You may even be able to stop the headache pain from occurring. Lying down in a quiet, dark room after taking the medicine also helps to relieve headaches.
People who get frequent headaches may need to take a different medicine to help prevent the headaches. It is important that you follow your physician's directions about taking the other medicine, even if your headaches continue to occur. Some headache-preventing medications may take several weeks to start working. Even after they start working, your headaches may not go away completely. However, headaches should occur less frequently. And they should be less severe and easier to relieve than before. This will reduce the amount of headache relief medication you need. If you do not notice any improvement after several weeks of headache-preventing treatment, contact your doctor.
ESGIC PLUS DOSING
The dose of acetaminophen and butalbital combination medicines will be different for different people. Follow your physician's orders or the directions on the label. The following includes only the average doses of these medicines. If your dose is different, do not change it unless your physician tells you to do so.
The number of tablets or capsules that you take depends on the strength of the medicine.
For oral dosage forms (capsules or tablets): For tension headaches: Adults. One or two tablets or capsules every four hours as needed. If your medicine contains 325 or 500 milligrams of acetaminophen in each tablet or capsule, do not take more than six capsules or tablets a day. If your medicine contains 650 milligrams of acetaminophen in each tablet or capsule, do not take more than four capsules or tablets a day.
Children. Dose must be determined by your doctor.
Check with your doctor:
Check the labels of all nonprescription or prescription medicines you now take to see if they contain a barbiturate or acetaminophen. If they do, check with doctor. Taking them together with Esgic Plus may cause an overdose.
The butalbital in Esgic Plus will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, which can causing drowsiness). Check with your doctor before taking any of CNS depressants. Some examples are:
Consuming alcoholic beverages regularly while taking this medicine may increase the chance of liver damage, especially if you take more than your doctor ordered or if you take it regularly for a long time. Do not drink alcoholic beverages while you are using Esgic Plus.
Esgic Plus may cause drowsiness, dizziness or lightheadedness in some people. Make sure you know how you your body reacts to before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert and clearheaded.
Before you have any medical tests, tell the person in charge that you are taking Esgic Plus. Caffeine, which is present in some butalbital and acetaminophen combinations, interferes with the results of some lab tests that use dipyridamole (like Persantine) to help show how well blood is flowing to your heart. Do not consume caffeine for 8 to 12 hours before the test. The results of other tests may also be affected by acetaminophen and butalbital combinations.
Before having any kind of surgery (this includes dental surgery) or emergency treatment, tell the physician or dentist in charge that you are taking Esgic Plus. Serious side effects can occur if your physician or dentist gives you certain medicines without knowing that you have taken butalbital.
If you have been taking large amounts of Esgic Plus, or if you have been taking it regularly for several weeks or more, do not suddenly stop taking it without first checking with your physician. He or she may want you to gradually reduce the amount you are taking before stopping completely in order to lessen the chance of withdrawal side effects.
ESGIC PLUS OVERDOSE
If you think you or anyone else may have taken an overdose of Esgic Plus, get emergency help at once. Taking an overdose or consuming alcohol or CNS depressants with this medicine may lead to unconsciousness or possibly death. Signs of butalbital overdose include
Signs of severe acetaminophen poisoning may not show up until 2 to 4 days after the overdose is taken. But treatment to prevent liver damage or death must be started within 24 hours or less after the overdose is taken.
ESGIC PLUS SIDE EFFECTS
If you experience any of these side effects from Esgic Plus they may need medical attention.
Call your physician immediately if any of the following side effects occur, especially if several of them occur at the same time:
Call your doctor as soon as possible if any of the following side effects occur:
Other Esgic Plus side effects may occur that usually do not need medical attention. These side effects can cease during treatment as your body adjusts to the medicine. However, check with your physician if any of the following side effects continue or are bothersome:
Other side effects not listed may also occur. If you notice any other effects, check with your doctor.
ESGIC PLUS OVERSODE
Symptoms of an overdose:
If your physician has ordered you to take this medicine on a regular schedule and you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the dose which was missed and go back to your regular dosing schedule. Do not take double doses.
To store this medicine:
Keep out of the reach of children. An overdose is especially dangerous in young children.
Store away from excessive heat and direct light.
Do not store in the bathroom, near the kitchen sink or in other damp places. Heat or moisture may cause the medicine to break down.
Do not keep expired medicine or medicine no longer needed. Be sure that discarded medicine is out of the reach of children.
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