Buprenorphine / naloxone Oromucosal, Sublingual

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Cough or hoarseness
• feeling faint, dizzy, or lightheaded
• feeling of warmth or heat
• fever or chills
• flushing or redness of the skin, especially on the face and neck
• headache
• lower back or side pain
• painful or difficult urination
• sweating

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• rapid weight gain
• tingling of the hands or feet
• unusual weight gain or loss

Get emergency help immediately if any of the following symptoms of overdose occur:

• Blurred vision
• confusion
• difficult or troubled breathing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drowsiness
• irregular, fast, slow, or shallow breathing
• pale or blue lips, fingernails, or skin
• pinpoint pupils
• relaxed and calm feeling
• sleepiness
• unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Abdominal or stomach pain
• difficulty having a bowel movement (stool)
• lack or loss of strength
• nausea
• pain
• trouble sleeping
• vomiting

• Back pain
• diarrhea
• runny nose
• sneezing
• stuffy nose

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.