Suboxone (Buprenorphine and Naloxone) 30 sublingual films per package

What is Suboxone?

Generic Name: buprenorphine and naloxone(BUE pre NOR feen and nal OX one)
Brand Names: Bunavail, Suboxone, Zubsolv

Suboxone contains a combination of buprenorphine and naloxone. Buprenorphine is an opioid medication. An opioid is sometimes called a narcotic. Naloxone blocks the effects of opioid medication, including pain relief or feelings of well-being that can lead to opioid abuse.

Suboxone is used to treat narcotic (opiate) addiction. It is not for use as a pain medication.

Suboxone may also be used for purposes not listed in this medication guide.

Important information

Suboxone can slow or stop your breathing.Never take Suboxone in larger amounts, or for longer than prescribed.

Suboxone may also be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medicine in a place where others cannot get to it.

MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Suboxone may be habit-forming, even at regular doses. Take this medicine exactly as prescribed by your doctor. Never share the medicine with another person. MISUSE OF NARCOTIC PAIN MEDICATION CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Before taking this medicine

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

To make sure this medicine is safe for you, tell your doctor if you have:

• 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 history of drug abuse, alcohol addiction, or mental illness; or
• a history of head injury, brain tumor, or seizures.

Buprenorphine may be habit forming. Never share Suboxone with another person, especially someone with a history of drug abuse or addiction.Keep this medication in a place where others cannot get to it. Selling or giving away Suboxone to any other person is against the law

It is not known whether Suboxone will harm an unborn baby. If you use buprenorphine and naloxone 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 and naloxone can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

How should I take Suboxone?

Take Suboxone exactly as directed by your doctor. Follow all directions on your prescription label. Suboxone can slow or stop your breathing. Never take this medicine in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Suboxone may be habit-forming, even at regular doses. Take this medicine exactly as prescribed by your doctor. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away Suboxone is against the law.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Use dry hands when handling the tablet or film. Ask your doctor or pharmacist if you have any questions.

Before taking this medicine, drink a glass of water to moisten your mouth. Place the sublingual film under the tongue and allow it to dissolve. Do not chew the tablet or film, and do not swallow it whole.

If you switch between medicines containing buprenorphine, you may not use the same dose for each one. Follow all directions carefully.

Do not stop using Suboxone suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

You will need frequent blood tests to check your liver function.

Wear a medical alert tag or carry an ID card stating that you take Suboxone. Any medical care provider who treats you should know that you are being treated for narcotic addiction. Make sure your family members know you are using buprenorphine in case they need to speak for you during an emergency.

Never crush or break a Suboxone pill to inhale the powder or mix it into a liquid to inject the drug into your vein. This practice has resulted in death.

Store at room temperature away from moisture and heat. Keep the sublingual film in the foil pouch until ready to use. After opening a pouch, you must use the medicine right away. Discard the empty pouch in a place children and pets cannot get to.

Keep track of the amount of medicine used from each new bottle. Buprenorphine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Do not keep leftover Suboxone tablets or films. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, remove any unused tablets or film from all packaging and flush them down the toilet. Disposal of medicines by flushing is recommended to reduce the danger of accidental overdose causing death. This advice applies to a very small number of medicines only. The FDA, working with the manufacturer, has determined this method to be the most appropriate route of disposal and presents the least risk to human safety.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A Suboxone overdose can be fatal, especially in a child or other person using the medicine without a prescription.

Overdose symptoms may include blurred vision, severe drowsiness, slurred speech, loss of coordination, thinking problems, weakness or limp feeling, and weak or shallow breathing (breathing may stop).

What should I avoid?

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with Suboxone. Check your food and medicine labels to be sure these products do not contain alcohol.

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Suboxone side effects

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

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

• extreme weakness or drowsiness, weak or shallow breathing;
• confusion, blurred vision, slurred speech;
• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• a light-headed feeling, like you might pass out; or
• withdrawal symptoms – diarrhea, vomiting, shaking or shivering, runny nose, watery eyes, muscle pain, and feeling very hot or cold.

This medicine is more likely to cause breathing problems in older adults and people who are severely ill, malnourished, or otherwise debilitated.

Common Suboxone side effects may include:

• tongue pain, redness or numbness inside your mouth;
• constipation, mild nausea, vomiting;
• headache or other pain;
• sleep problems (insomnia);
• increased sweating; or
• swelling in your arms or legs.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.