This medicine can slow or stop your breathing, and may be habit-forming. MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Taking Suboxone during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

You should not use Suboxone if you are allergic to buprenorphine or naloxone (Narcan).

Tell your doctor if you have ever had:

• any type of breathing problem or lung disease;

• enlarged prostate, urination problems;

• liver or kidney disease;

• abnormal curvature of the spine that affects breathing;

• problems with your gallbladder, adrenal gland, or thyroid;

• a head injury, brain tumor, or seizures; or

• alcoholism, drug addiction, mental illness.

Some medicines can interact with buprenorphine and naloxone and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take stimulant medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

If you use Suboxone while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant.

Buprenorphine and naloxone can pass into breast milk and may cause drowsiness or breathing problems in the nursing baby. Tell your doctor if you are breast-feeding.

Get emergency medical help if you have signs of an allergic reaction to Suboxone: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Like other narcotic medicines, Suboxone can slow your breathing. Death may occur if breathing becomes too weak. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once or seek emergency medical attention if you have:

• weak or shallow breathing, feeling like you might pass out;

• confusion, loss of coordination, extreme weakness;

• blurred vision, slurred speech;

• liver problems - upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice(yellowing of the skin or eyes);

• low cortisol levels - nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or

• opioid withdrawal symptoms - shivering, goose bumps, increased sweating, feeling hot or cold, runny nose, watery eyes, diarrhea, muscle pain.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common Suboxone side effects may include:

• dizziness, drowsiness, blurred vision, feeling drunk, trouble concentrating;

• withdrawal symptoms;

• tongue pain, redness or numbness inside your mouth;

• nausea, vomiting, constipation;

• headache, back pain;

• fast or pounding heartbeats, increased sweating; or

• sleep problems (insomnia).