When This Medicine Should Not Be Used:
This medicine is not right for everyone. You should not receive it if you had an allergic reaction to buprenorphine or any other ingredients of the implant (such as ethylene vinyl acetate).

How to Use This Medicine:
Implant

• This medicine is an implant that is surgically placed and removed under the skin of the upper arm by a trained healthcare provider. The implants are placed in the upper arm for 6 months of treatment and are removed by the end of the sixth month.
• Your doctor will treat the arm with numbing medicine and then cut a small incision to insert the implant with a special tool. The incision will be covered with 2 bandages. The top adhesive bandage will be placed over the arm and should be left on for 24 hours. Keep the smaller, bottom bandage clean and dry and in place for 3 to 5 days.
• You should apply an ice pack to your arm for 40 minutes every 2 hours for the first 24 hours after placing the implants or as needed.
• Your doctor will give you a patient identification card to carry with you.
• Do not try to remove the implants by yourself.
• If the implant sticks out or comes out: Wash your hands if you touch the implant. Cover the area where the implants were inserted with a clean bandage. Place the implant in a plastic bag, store it in a safe place out of the reach of children, and call your doctor right away.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

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 foods and medicines can affect how buprenorphine/naloxone works. Tell your doctor if you are using the following:
  
  • Carbamazepine, mirtazapine, phenobarbital, phenytoin, rifampicin, tramadol, trazodone
  • Medicine to treat an infection (including erythromycin, ketoconazole)
  • Medicine to treat HIV/AIDS (including atazanavir, indinavir, ritonavir, saquinavir)
  • Medicine to treat depression
  • Phenothiazine medicine
  • Tranquilizer or benzodiazepine medicine
• Do not drink alcohol while you are using this medicine.
• Some pain relievers, allergy medicines, or sleeping pills may cause you to feel more lightheaded, dizzy, or faint when used with this medicine. Tell your doctor if you use any medicine that makes you drowsy.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease (including hepatitis), adrenal gland problems, an enlarged prostate, trouble urinating, gallbladder problems, thyroid problems, lung or breathing problems, mental health problems, a head injury or brain problem, or a history of alcohol abuse. Tell your doctor if you have a history of keloid formation, connective tissue disease (such as scleroderma), or MRSA infections. Tell your doctor if you have an allergy to numbing medicines or medicines used to clean your skin.
• This medicine may cause the following problems:
  
  • High risk of overdose, which can lead to death
  • High risk of liver problems
• This medicine may make you dizzy or drowsy. Do not drive or do anything that could be dangerous until you know how this medicine affects you. Stand or sit up slowly if you feel lightheaded or dizzy.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• 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 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.

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
• Anxiety, restlessness, fast heartbeat, fever, sweating, muscle spasms, twitching, diarrhea, seeing or hearing things that are not there
• Bleeding, itching, pain, redness, scarring, or swelling at the insertion or removal site of the implant
• Blue lips, fingernails, or skin
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Extreme weakness, shallow breathing, sweating, seizures, cold or clammy skin
• Numbness or weakness in your arm, trouble breathing
• Severe confusion, lightheadedness, dizziness, or fainting

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

• Back pain
• Constipation
• Headache

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