Suboxone (Buprenorphine and Naloxone Sublingual Film)

• Tell all of your health care providers that you take Suboxone. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may be habit-forming with long-term use.
• Do not stop taking Suboxone all of a sudden without calling your doctor. You may have a greater risk of signs of withdrawal. If you need to stop this medicine, you will want to slowly stop it as ordered by your doctor.
• Do not switch between different forms of Suboxone without first talking with the doctor.
• Long-term use of an opioid drug like this medicine may lead to lower sex hormone levels. This may lead to signs like change in sex ability in men, no menstrual period in women, lowered interest in sex, or fertility problems. Call your doctor if you have any of these signs.
• This medicine may raise the chance of seizures in some people, including people who have had seizures in the past. Talk to your doctor to see if you have a greater chance of seizures while taking Suboxone.
• Even one dose of this medicine may be deadly if it is taken by someone else or by accident, especially in children. If Suboxone (buprenorphine and naloxone sublingual film) is taken by someone else or by accident, get medical help right away.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Suboxone while you are pregnant.
• Using this medicine for a long time during pregnancy may lead to withdrawal in the newborn baby. This can be life-threatening. Talk with the doctor.
• Tell your doctor if you are breast-feeding or plan to breast-feed. This medicine passes into breast milk and may harm your baby.

Use Suboxone as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• To gain the most benefit, do not miss doses.
• Take this medicine at the same time of day.
• Do not chew or swallow.
• Do not eat, drink, smoke, or talk while Suboxone is melting.
• Take by mouth only. Very bad and sometimes deadly side effects may happen if this medicine is injected.
• Open right before use.
• Be sure your hands are dry before you touch Suboxone.
• This medicine must be taken whole. Do not cut or tear this medicine. Do not touch the film with your tongue or finger once it has been placed.
• Place Suboxone under the tongue or on the inside of the cheek.
• If using under the tongue, wet mouth with water. Place film under the tongue and let it melt.
• If using on the inside of the cheek, wet the inside of your cheek with your tongue or water. Place the film inside the mouth on a wet cheek and let it melt.
• If using 2 films, place on opposite sides. Try not to let films touch.
• If using 3 films, place the third film under the tongue after the first 2 films have melted.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• If you are not sure what to do if you miss a dose, call your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad dizziness or passing out.
• Trouble breathing, slow breathing, or shallow breathing.
• Feeling very sleepy.
• Feeling confused.
• Very hard stools (constipation).
• Change in eyesight.
• Feeling very tired or weak.
• Feeling nervous and excitable.
• Change in balance.
• Mood changes.
• Anxiety.
• Extra muscle action or slow movement.
• Slurred speech.
• Very bad and sometimes deadly liver problems have happened with this medicine. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Taking an opioid drug like Suboxone may lead to a rare but very bad adrenal gland problem. Call your doctor right away if you have very bad dizziness or passing out, very bad upset stomach or throwing up, or if you feel less hungry, very tired, or very weak.
• A very bad and sometimes deadly health problem called serotonin syndrome may happen if you take this medicine with drugs for depression, migraines, or certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Feeling sleepy.
• Upset stomach or throwing up.
• Hard stools (constipation).
• Headache.
• Belly pain.
• Not able to sleep.
• Feeling tired or weak.
• Sweating a lot.
• Flushing.
• Burning.
• Numbness or tingling in the mouth.
• Pain where it was placed.
• Redness.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.