Fentanyl Oral Lozenge (FENTANYL LOZENGE - BUCCAL)

Instructions

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

Do not place the medicine over open sores or lesions.

Drink some water to moisten your mouth before using the medicine.

Place the medicine end between your cheek and gum. Twirl the handle often and suck on the medicine. Occasionally move the medicine to the other side of your mouth.

Avoid chewing the medicine.

Avoid eating food or drinking liquids until the medicine has dissolved completely.

Start taking this medicine as soon as you develop symptoms.

Store at room temperature away from heat, light, and moisture. Do not keep in the bathroom.

Please ask your doctor, nurse, or pharmacist how to discard unused medicines safely.

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

Avoid grapefruit juice while on this medicine.

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.

Do not take the medicine more than four times during 24 hours.

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.

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.

If you have dizziness, drowsiness, or nausea before the tablet has dissolved, remove the tablet from your mouth and rinse your mouth with water. Contact your doctor to see if you need a lower dose.

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.

This medicine should be used with caution in patients with breathing difficulties.

Call your doctor right away if you notice slow or shallow breathing.

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
• headaches
• lightheadedness
• irritation of mouth and gum tissue
• nausea and vomiting

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

• agitated feeling or trouble sleeping
• decreased awareness or responsiveness
• breathing interruption during sleep
• shallow, irregular breathing
• confusion
• fainting
• hallucinations (unusual thoughts, seeing or hearing things that are not real)
• fast, irregular, or slow heartbeat
• muscle trembling
• seizures
• severe stomach or bowel pain
• unusual or unexplained tiredness or weakness
• 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.