buprenorphine-naloxone-sublingual (cont.)
SIDE EFFECTS: Drowsiness, dizziness, weakness, constipation, headache, nausea, or vomiting may occur. If any of these effects persist or worsen, notify your doctor or pharmacist immediately. Tell your doctor immediately if any of these unlikely but serious side effects occur: slow, shallow breathing, mental/mood changes (e.g., depression), stomach/abdominal pain. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: dark urine, yellowing eyes and skin, vision changes. An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing. Narcotic withdrawal symptoms include diarrhea, severe mental/mood changes (such as anxiety, irritability, trouble sleeping), muscle stiffness or shakiness. If such symptoms occur, notify your doctor or pharmacist immediately. If you notice other effects not listed above, contact your doctor or pharmacist.
PRECAUTIONS: Before using this medication, tell your doctor or pharmacist your medical history, especially of: lung disease, liver disease, serious head injury or brain diseases (lesions), low thyroid problems (hypothyroidism), adrenal problems (Addison's disease), psychiatric problems (toxic psychosis), difficulty urinating (enlarged prostate or urethral narrowing), acute alcoholism (with or without delirium tremens), spinal problems (kyphoscoliosis), gallbladder (biliary tract) disease and other abdominal conditions, any allergies. This drug may make you dizzy or drowsy; use caution engaging in activities requiring alertness such as driving or using machinery. Avoid alcoholic beverages. To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position. Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially the possible decreased breathing and drowsiness effects. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. This drug passes into breast milk. Due to the potential risk to the infant, breast-feeding while using this drug is not recommended.
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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