Important directions about SUBOXONE use
Intravenous misuse of buprenorphine, usually in combination with benzodiazepines or other CNS depressants (including alcohol) has been associated with significant respiratory depression and death.

SUBOXONE combined with medications/drugs
It can be dangerous to mix SUBOXONE with drugs like benzodiazepines, alcohol, sleeping pills and other tranquilizers, certain antidepressants, or other opioid medications, especially when not under the care of a doctor or in doses different from those prescribed by your doctor. Mixing these drugs can lead to drowsiness, sedation, unconsciousness, and death, especially if injected. It is important to let your doctor know about all medications and substances you are taking. Your doctor can provide guidance if any of these medications are prescribed for the treatment of other medical conditions you may have.

Potential for dependence
SUBOXONE and SUBUTEX® CIII (buprenorphine HCl sublingual tablets) have potential for abuse and produce dependence of the opioid type with a milder withdrawal syndrome than that of full agonists.

Contact your doctor if

• You feel faint, dizzy, confused, or have any other unusual symptoms, or if your breathing becomes much slower than normal. These can be signs of taking too much SUBOXONE or of other serious problems.
• You experience an allergic reaction. Symptoms of a bad allergic reaction include difficulty breathing, hives, swelling of your face, asthma (wheezing), or shock (loss of blood pressure and consciousness)
• You suspect liver problems due to any of these symptoms:
• Your skin or the white part of your eyes turns yellow (jaundice)
• Your urine turns dark
• Your bowel movements (stools) turn light in color
• You don't feel like eating much food for several days or longer
• You feel sick to your stomach (nauseated)
• You have lower-stomach pain
• Cytolytic hepatitis and hepatitis with jaundice have been observed in the addicted population receiving buprenorphine.
• Your doctor may do blood tests while you are taking SUBOXONE to ensure that your liver is okay.
• You've recently experienced a head injury (SUBOXONE can alter pupil size and cause changes in the level of consciousness that may interfere with patient evaluation)

Pregnancy
There are no adequate and well-controlled studies of SUBOXONE (a Category C medication) in pregnancy. SUBOXONE should not be taken during pregnancy unless your doctor determines that the potential benefit to you justifies the potential risk to your unborn child. Contraception should be used while taking SUBOXONE. If you are considering becoming pregnant or do become pregnant while taking SUBOXONE, consult your doctor immediately.

Many women also have changes in menstruation when they use opioids. This may continue while you are taking SUBOXONE. It is important to remember that you can still become pregnant even with irregular periods.

Breast-feeding
Buprenorphine will pass through a mother's milk and may harm the baby, so SUBOXONE is not recommended if you are breast-feeding. Your doctor should know if you are breast-feeding before you start treatment for opioid dependence.

Driving and operating machinery
SUBOXONE can cause drowsiness and slow reaction times. This may occur more often in the first few weeks of treatment, when your dose is being changed, but can also occur if you drink alcohol or take other sedative drugs when you are taking SUBOXONE. Caution should be exercised when driving cars or operating machinery.

Commonly reported side effects
Side effects of SUBOXONE are similar to those of other opioids. The most commonly reported adverse events with SUBOXONE include: headache (36%, placebo 22%), withdrawal syndrome (25%, placebo 37%), pain (22%, placebo 19%), insomnia (14%, placebo 16%), nausea (15%, placebo 11%), and constipation (12%, placebo 3%). Please see full Product Information for a complete list. You may already be experiencing some of these side effects because of your current use of opioids. If so, let your doctor know. Your doctor can effectively treat many of these symptoms.

SUBOXONE can cause blood pressure to drop. This can cause you to feel dizzy if you get up too fast from sitting or lying down.

Your doctor will determine if you need to stop taking SUBOXONE because of side effects.

SUBOXONE use in children
SUBOXONE can be used in people ages 16 and older. It hasn't been approved for use in children younger than 16. Accidental overdose in children is dangerous and can result in death. Always store buprenorphine-containing medications safely and out of the reach and sight of children. Destroy any unused medication appropriately.

Appropriate use of SUBOXONE
Do not use SUBOXONE or SUBUTEX for conditions for which they were not prescribed. Patients with a clinical need for analgesia should not be transferred to a SUBOXONE regimen. SUBOXONE is not indicated for pain management.

Do not give your medication to other people, even if they have the same symptoms that you have. Sharing is illegal and may cause severe medical problems.