Buprenorphine Transdermal System (BUPRENORPHINE - TRANSDERMAL)

Instructions

DO NOT take this medicine by mouth.

Keep the medicine at room temperature. Avoid heat and direct light.

This patch should not be cut.

Wash your hands before and after handling this medicine.

Remove old patch before applying new one. Change the location of the new patch.

Do not use if the pouch containing the medicine is torn or damaged.

Do not use the patch if it is broken, cut, or damaged.

Ask your doctor or pharmacist about locations on your body where this patch can be used.

Remove the plastic liner that protects the sticky side of the patch before applying to the skin.

Before applying the patch, clean the skin with water. Gently pat dry. Do not rub the skin. Do not use soap, oils, or alcohol. Do not shave the hair. It irritates the skin. If needed, cut the hair close to the skin with scissors.

Apply the patch to a clean, dry, hairless area. Avoid skin that is red, scraped, or damaged.

Press patch firmly for a few seconds to make sure it sticks. If it does not, talk to your doctor or pharmacist. Do not cover with a bandage or tape unless your doctor or pharmacist says to.

After removing the patch, fold it together and discard it out of reach of children and pets.

Avoid getting the medicine in the eyes, nose, or mouth. Wash your hands after touching patch.

Please ask your doctor or pharmacist how you can safely dispose of used patches.

If the skin under the patch becomes irritated, remove the patch. Do not apply a new patch to the area until the skin feels better.

To avoid skin irritation, wait at least three weeks before using the patch on same location again.

If the patch falls off or a dose is missed, apply a new patch immediately to a different location. Wait 7 days to replace this new patch.

Do not apply heat on the area with the patch. Avoid heating blankets, suntan beds, or hot tubs.

You can bathe, swim or shower while wearing the patch.

Avoid activities that can increase the body temperature. Tell your doctor if you have fever.

If the patch leaks any medicine, do not touch it with your skin. Wash the area of the skin with lots of water.

Avoid touching or scratching the area of the skin after the patch is removed.

To reduce constipation, eat high fiber foods, drink plenty of water and exercise.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Tell your doctor if symptoms do not get better or if they get worse.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

This medicine has an opioid. Opioids help many people but may cause addiction, especially if used for a long time. The addiction risk is higher if you have a substance use disorder (overuse of or addiction to drugs or alcohol). Ask your doctor about the benefits and risks.

Ask your doctor or pharmacist if you should have naloxone on hand to treat opioid overdose. Teach your family or household members about the signs of an opioid overdose and how to treat it.

If you stop this medicine suddenly after using it for a long time, you may have withdrawal. Your doctor may slowly lower your dose before stopping it. Tell your doctor right away if you have symptoms, such as unusual sweating, watering eyes, runny nose, chills, diarrhea, yawning, muscle aches, restlessness, anxiety, trouble sleeping, or thoughts of suicide.

Use medicine with caution if you have breathing problems. Get help right away for slow or shallow breathing.

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Do not use the medication any more than instructed.

If possible, avoid using with alcohol, marijuana, or other medicines that can cause dizziness or drowsiness. These include allergy/cold products, muscle relaxers, sleep aids, and pain relievers.

Your ability to stay alert or to react quickly may be impaired by this medicine. Do not drive or operate machinery until you know how this medicine will affect you.

This medicine passes into breast milk. Ask your doctor before breastfeeding.

This medicine can hurt a new baby in the womb. If you become pregnant while on this medicine, tell your doctor immediately. Your doctor may switch you to a different medicine.

Do not let other people touch the skin where this medicine is applied.

Do not share this medicine with anyone who has not been prescribed this medicine.

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• decreased appetite
• constipation
• dizziness or drowsiness
• lightheadedness
• nausea and vomiting
• skin irritation where medicine is applied

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• decreased awareness or responsiveness
• breathing interruption during sleep
• shallow, irregular breathing
• changes in memory, mood, or thinking
• confusion
• fainting
• hallucinations (unusual thoughts, seeing or hearing things that are not real)
• fast or irregular heart beats
• signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
• seizures
• difficulty or discomfort urinating
• weight loss

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.