TRAMADOL/ACETAMINOPHEN-ORAL (cont.)
PRECAUTIONS: Tell your doctor your medical history, especially of: liver disease, kidney problems, seizure disorder, drug or alcohol dependency, lung/breathing problems, any allergies (especially to codeine). This drug may make you dizzy or drowsy; use caution engaging in activities requiring alertness such as driving or using machinery. Avoid alcoholic beverages. This product contains acetaminophen. Acetaminophen may cause liver damage. Daily use of alcohol, especially when combined with acetaminophen, may increase your risk for liver damage. Check with your doctor or pharmacist for more information. Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known whether this drug passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Tell your doctor of all prescription and nonprescription medication you may use, especially: carbamazepine, narcotic pain relievers (e.g., codeine), quinidine, digoxin, antidepressants (e.g., tricyclics such as amitriptyline or SSRIs such as fluoxetine or paroxetine), "blood thinners" (e.g., warfarin), "triptan"-type migraine drugs (e.g., sumatriptan, zolmitriptan), MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, selegiline, tranylcypromine), sibutramine, nefazodone, venlafaxine. Tell your doctor if you take other drugs that may increase your risk of seizures such as: theophylline, caffeine, adrenalin-like drugs (e.g., amphetamine, methylphenidate), isoniazid, tacrine, salicylates, donepezil. Tell your doctor if you take any drugs that cause drowsiness such as: medicine for sleep, sedatives, tranquilizers, anti- anxiety drugs (e.g., diazepam), psychiatric medicines (e.g., phenothiazines such as chlorpromazine), anti-seizure drugs (e.g., topiramate), muscle relaxants, certain antihistamines (e.g., diphenhydramine). Acetaminophen is an ingredient in many nonprescription products and in some combination prescription medications. Read the labels carefully before taking other pain relievers, fever reducers, or cold products to see if they also contain acetaminophen. Consult your pharmacist if you are uncertain if your other prescription or nonprescription products contain acetaminophen. (Also see adult maximum daily dose information in Side Effects section). Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of these products. Do not start or stop any medicine without doctor or pharmacist approval.
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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