BUPRENORPHINE SUBLINGUAL

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• Minor side effects (if these symptoms persist or worsen, inform your doctor)
  • Drowsiness, dizziness, constipation, or headache
  • To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener)
  • To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
•  Serious side effects (inform your doctor immediately)
  • Severe (possibly fatal) breathing problems can occur if this medication is abused, injected, or mixed with other depressants (such as alcohol, benzodiazepines including diazepam, other narcotics)
  • Mental/mood changes (such as agitation, confusion, hallucinations), stomach/abdominal pain
  • May rarely cause narcotic withdrawal symptoms
    • Diarrhea, severe mental/mood changes (such as anxiety, irritability, trouble sleeping), muscle stiffness or shakiness
      • More likely when starting treatment or if you have been using long-acting narcotics such as methadone
  • May rarely cause serious liver disease, with symptoms of:
    • : dark urine, persistent nausea/vomiting, yellowing eyes/skin, severe stomach/abdominal pain
• Severe allergic reactions are rare. Get immediate medical help if you notice the following:
  • Rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing

Precautions

• Inform your doctor
  • Allergy to the medication or any allergies
  • Medical History, especially of:
    • brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), liver disease, mental/mood disorders (such as confusion, depression), stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus), difficulty urinating (such as due to enlarged prostate)
• May cause dizziness or drowsiness
  • 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. Alcohol also increases your risk for breathing problems.
• May cause QT prolongation, a condition that affects the heart rhythm
  • Risk increases if you have the following conditions”
    • Heart problems, family history of certain heart problems
    • Low levels of potassium or magnesium
      • Usage of such as diuretics/”water pills” or presence of conditions such as severe sweating, diarrhea, or vomiting
• Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
• Elderly may be more sensitive to the side effects of this drug, especially confusion, dizziness, drowsiness, slow/shallow breathing, and QT prolongation
• During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, take the smallest effective dose for the shortest possible time. Tell the doctor right away if you notice any symptoms in your newborn baby such as slow/shallow breathing, irritability, abnormal/persistent crying, vomiting, or diarrhea.
• Consult your doctor before breast-feeding as this medication passes into breast milk and may cause unwanted effects on your baby

Interactions

Taking multiple drugs may affect how medications work and/or cause unwanted side effects. List down all the medications you are taking and inform your physician and pharmacist. Do not take, discontinue, or alter any dose of medications without prior approval of your physician.

• Products that may interact with this medication include:
  • narcotic antagonists (such as naltrexone), certain narcotic pain medications (mixed narcotic agonist-antagonists such as butorphanol, nalbuphine, pentazocine).
  • Many drugs besides buprenorphine may affect the heart rhythm (QT prolongation), including amiodarone, disopyramide, dofetilide, ibutilide, procainamide, quinidine, sotalol
• The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if used with the following:
  • Alcohol, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), and other narcotic pain relievers (such as codeine, hydrocodone)
• Deaths have occurred when buprenorphine has been misused by injecting it (“shooting up”), especially when used in combination with benzodiazepines (such as diazepam) or other depressants such as alcohol or additional narcotics.

Overdose

If overdose is suspected, contact a poison control center or emergency room immediately.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and as soon as you remember, take a regular dose or if the time of the next dose is near, wait for it before taking another dose and resume your usual schedule. Do not increase the dose to compensate for the missed dose.

Storage

• Room temperature
• Do not expose to light and moisture
• Do not store in the bathroom
• Keep all medications away from pets and children
• Do not flush medications down the toilet or pour them into a drain unless instructed to do so
• Properly discard this product when it is expired or no longer needed
  • Consult your pharmacist or local waste disposal company for more details about how to safely discard your product