When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to buprenorphine or adhesives, or if you have severe breathing or lung problems or paralytic ileus.

How to Use This Medicine:
Patch

• Your doctor will tell you how many patches to use, where to apply them, and how often to apply them. Do not use more patches or apply them more often than your doctor tells you to. An overdose can be dangerous. Follow directions carefully so you do not get too much medicine at one time.
• Wash your hands with soap and water before and after applying a patch.
• Leave the patch in its sealed wrapper until you are ready to put it on. Tear the wrapper open carefully. NEVER CUT the wrapper or the patch with scissors. Do not use any patch that has been cut by accident. Do not use this medicine if the pouch seal is broken or if the patch is damaged in any way. If any medicine leaks out of the patch and gets directly on your skin, wash it off right away with water.
• Do not use soap, lotion, alcohol, or oil on your skin before you apply the patch. Wash your skin only with water and let it dry completely. Do not shave the skin where you will apply the patch. You may cut the hair with a pair of scissors.
• The patient instructions will show the body areas where you can wear the patch. When putting on each new patch, choose a different place within these areas. Do not put the new patch on the same place you wore the last one. Be sure to remove the old patch before applying a new one. After you apply the patch, push down on it with the palm of your hand for 15 seconds to make sure it sticks to your skin.
• Do not put the patch over burns, cuts, or irritated skin.
• Put on a new patch if the old one has fallen off and cannot be reapplied. If a patch is loose, tape it to your skin with first aid tape.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.
• Store the patches at room temperature in the original package, away from heat, moisture, and direct light.
• Disposal: Follow the instructions you receive with the patch disposal unit. You will need to seal each patch in a disposal unit, even if it is a patch you did not use. If you have questions, ask your pharmacist about the best way to dispose of used or leftover patches. Make sure children and pets cannot come in contact with used or leftover patches. Wash your hands thoroughly with soap and water after you handle the patch. If you must dispose of a patch without the patch disposal unit, be sure you fold it in half with the sticky sides together so no one comes in contact with the medicine. Then dispose as directed by your doctor or pharmacist.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how buprenorphine works. Tell your doctor if you are using any of the following:
  
  • Carbamazepine
  • HIV/AIDS medicine
  • A phenothiazine medicine
  • Medicine to treat heart rhythm problems, such as amiodarone, disopyramide, dofetilide, procainamide, quinidine, sotalol
• Do not drink alcohol while you are using this medicine.
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol. Tell your doctor if you are also using muscle relaxers.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, lung disease or breathing problems (such as COPD), heart disease, heart rhythm problems, gallbladder problems, low blood pressure, pancreas problems, or stomach or bowel problems. Tell your doctor if you have a history of head injury, brain tumor, seizures, depression, or alcohol or drug abuse.
• This medicine may cause the following problems:
  
  • High risk of overdose, which can lead to death
  • Respiratory depression (serious breathing problem that can be life-threatening)
  • Heart rhythm problems
• Do not let the patch get too hot. Avoid direct sunlight, and do not use a heating pad, electric blanket, heated waterbed, sauna, sun lamp, or hot tub. Call your doctor if you have a fever higher than 102 degrees F.
• Be careful about letting other people come in contact with your patch. If any medicine gets on another person, wash it off right away with water.
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• This medicine may make you lightheaded, dizzy, or drowsy. Do not drive or do anything that could be dangerous until you know how this medicine affects you. Sit or lie down if you feel dizzy. Stand up carefully.
• This medicine may cause constipation, especially with long-term use. Ask your doctor if you should use a laxative to prevent and treat constipation.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blue lips, fingernails, or skin
• Extreme dizziness or weakness, shallow breathing, sweating, seizures, cold or clammy skin
• Fast, slow, or uneven heartbeat
• Severe confusion, lightheadedness, dizziness, fainting
• Severe constipation, stomach pain, or vomiting
• Swelling, burns, or blisters where the patch is placed
• Trouble breathing or slow breathing
• Yellow skin or eyes

If you notice these less serious side effects, talk with your doctor:

• Headache
• Mild constipation, nausea, or vomiting
• Mild sleepiness or tiredness
• Redness, itching, or mild skin rash where the patch is placed

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088