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Butisol Consumer (continued)
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 unlikely but serious side effects occur: mental/mood changes (such as agitation, confusion, depression, hallucinations, thoughts of suicide, nightmares), slurred speech, staggering walk/clumsiness, double vision, memory problems.
Rarely, after taking this drug, people have gotten out of bed and driven vehicles while not fully awake ("sleep-driving"). People have also sleepwalked, or have prepared/eaten food, made phone calls, or had sex while not fully awake. Often these people do not remember these events. If you discover that you have done any of these things, tell your doctor immediately. Drinking alcohol, taking other medications that cause drowsiness, or taking higher doses of butabarbital may increase your risk for this effect. Do not drink alcohol while using this medication.
Tell your doctor immediately if any of these rare but very serious side effects occur: slow/shallow breathing, fainting, slow heartbeat.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: 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.
Read the Butisol (butabarbital sodium tablets) Side Effects Center for a complete guide to possible side effects »
PRECAUTIONS: Before taking butabarbital, tell your doctor or pharmacist if you are allergic to it; or to other barbiturates (such as phenobarbital); 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: certain hormone problems (adrenal disease such as Addison's disease), liver problems, kidney problems, lung disease (such as sleep apnea, chronic obstructive pulmonary disease-COPD), mental/mood disorders (such as depression, thoughts of suicide), history of alcohol/substance abuse, personal/family history of a certain blood disorder (porphyria).
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.
The liquid form of this product may contain alcohol. Caution is advised if you have diabetes, alcohol dependence, liver disease, or any other condition that requires you to limit/avoid alcohol in your diet. Ask your doctor or pharmacist about using this product safely.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Older adults may be more sensitive to the effects of this drug, especially drowsiness and dizziness. However, this drug can often cause excitement or confusion instead of drowsiness in older adults.
This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details. Since birth control pills may not be effective if taken with this medication (see also Drug Interactions section), discuss reliable forms of birth control with your doctor. If you become pregnant while taking this medication, notify your doctor immediately.
This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
Additional Butisol Information
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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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