Fentanyl Mucosal Spray 0.1 mg/actuation, 2 mg/Actuation, 4 mg/actuation, 6 mg/actuation, 8 mg/actuation

Instructions

Keep the medicine in the blister package until you are ready to use it.

Swallow any saliva in the mouth.

Hold the spray upright and point the nozzle into the mouth.

Spray the medicine underneath the tongue. Hold the medicine under the tongue for 30 to 60 seconds.

Do not spit out the medicine or rinse out the mouth after using the spray.

Start taking this medicine as soon as you develop symptoms.

If you need a second dose to relieve your pain, wait at least 30 minutes after the first dose.

Do not take more than 2 doses per episode of pain. Wait at least 4 hours before using the medicine again.

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.

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.

This medicine may cause dizziness or fainting, especially after exercising or in hot weather. Be very careful when standing or sitting up quickly.

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.

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.

• constipation
• dizziness or drowsiness
• lightheadedness
• 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 appetite
• 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 aches, spasms or abnormal movements
• 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.