Fentanyl Metered Dose Nasal Spray (FENTANYL SPRAY - NASAL)

Instructions

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

This medicine is for use in the nose. Avoid getting the medicine into the eyes or mouth. Rinse the eyes with water if the medicine is sprayed into the eyes.

Ask your doctor, nurse or pharmacist to show you how to use this medicine correctly.

The first time you open a new spray, you need to get it ready to use. Place the tip of the bottle inside the pouch and spray into it. Repeat this 3 more times. It is now ready to use. This process is called priming the spray.

Wash your hands before and after handling this medicine.

Blow and wipe your nose with a clean tissue before using this product.

This medicine is a very fine mist. Some patients may not feel the medicine. You should hear a click when this medicine is delivered. Do not use an extra dose of medicine if you do not feel the medicine being delivered.

If the pain does not improve after using the first dose, do not use a second dose. Ask the doctor what should be used instead to relieve this episode of pain.

Wait at least 2 hours between doses of this medicine.

Do not blow your nose for at least 30 minutes after using this medicine.

Keep track of number of times sprayed. Do not use more than the total number of doses shown on the package.

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.

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

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

Discard any unused medicine after 60 days.

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

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

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.

Be very careful not to spray the medicine into your eyes. Wash your hands thoroughly before touching your eyes.

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 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.

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
• 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.