Opvee

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Read the Patient Information Leaflet and Instructions for Use provided by your pharmacist when you get this medication and each time you get a refill. Be sure to keep this medication handy in case it is needed. Learn ahead of time how to properly give this medication. If you have any questions, ask your doctor or pharmacist.

Close family and household members should know the symptoms of an opioid overdose and be instructed on how to give nalmefene if needed. Opioid overdose should be treated right away to prevent serious effects (such as brain damage). See also Uses section.

Remove the nalmefene spray from the package only when you are ready to use it. Lay the person on their back. Tilt the person's head back and support their neck with your hand. Use your other hand to gently insert the tip of the spray nozzle into one nostril, then firmly press the plunger to give the dose. Remove the spray nozzle from the nostril and move the person onto their side.

After giving nalmefene, get medical help right away, even if the person wakes up. If symptoms return after giving the spray, give another dose in the other nostril every 2 to 5 minutes, changing nostrils with each dose. Each nasal spray contains only one dose and cannot be reused. Continue to closely watch the person until emergency help comes. Tell the health care professional that you have given nalmefene spray.

Nasal discomfort or stuffy nose may occur. Headache, nausea, flushing, or dizziness may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

In someone who has been using an opioid regularly, withdrawal symptoms can happen suddenly after receiving this medication. Withdrawal symptoms may include body aches, fever, sweating, watering eyes, runny nose, sneezing, goose bumps, yawning, weakness, shivering/trembling, nervousness, restlessness, diarrhea, nausea/vomiting, stomach cramps, increased blood pressure, or fast heartbeat.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Ask your doctor or pharmacist about ways to prevent opioid overdose. Teach your close family or household members the signs and symptoms of an opioid overdose and tell them where you keep this medication.

Not applicable.

Before using nalmefene, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Since untreated opioid overdose can harm both a pregnant woman and her unborn baby, this medication may be used during pregnancy. However, nalmefene may cause opioid withdrawal in your unborn baby. Tell your doctor right away that you used this medication, so you and your unborn baby can be monitored. Ask your doctor for details.

It is unknown if this medication passes into breast milk. However, it is unlikely to harm a nursing infant. Consult your doctor before breastfeeding.