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.

MIDAZOLAM SPRAY - NASAL

(mi-DAZ-oh-lam)

COMMON BRAND NAME(S): Nayzilam

WARNING: Using midazolam with opioid medications (such as codeine, hydrocodone) may increase your risk of very serious side effects, including death. To lower your risk, you should use the smallest dose of midazolam that works, and use it for the shortest possible time. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up.

USES: This medication is used by people with epilepsy to treat a certain type of serious seizure that doesn\'t stop (seizure clusters). Midazolam belongs to a class of drugs known as benzodiazepines. It may work by increasing the effect of a certain substance in your body (GABA), which helps calm the brain and nerves.

HOW TO USE: Read the Medication Guide 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 use this medication. Each nasal spray device can be used only one time. If you have any questions, ask your doctor or pharmacist. Caregivers should learn when this medication should be used and what to watch for after using this medication. Make sure a family member or caregiver knows where you keep this medication and how to use it in case you need their help. This product is for use in the nose only. Remove the midazolam spray from the package only when you are ready to use it. Do not test or prime the spray before use. Doing so will make you lose the dose. Gently insert the tip of the spray nozzle into one nostril, then firmly press the plunger to give the dose. This medication does not need to be inhaled to work. Throw away the nasal spray device after using it. If the seizure cluster is continuing 10 minutes after giving this medication, another dose may be given if available, and if you have been told to do so by the doctor. If using a second dose, give it in the opposite nostril. Do not use more than 2 doses to treat a seizure cluster episode. If the seizure cluster is continuing after using this medication as directed, get medical help right away. Do not use to treat episodes more often than once every 3 days, or more than 5 times in a month. Doing so may make this medication stop working well. Your seizures may get worse or happen more often. Talk with your doctor if this medication stops working well. If this medication has been regularly used and you suddenly stop using it, you may have withdrawal symptoms (such as vomiting, sweating, abdominal/muscle cramps, shaking, seizures, mental/mood changes such as anxiety/agitation). Withdrawal is more likely if you have used midazolam for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal. Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Use this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.

SIDE EFFECTS: See also Warning section. Drowsiness, dizziness, headache, or nasal discomfort may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she 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. Tell your doctor right away if you have any serious side effects, including: uncontrolled movements (such as shaking/tremor). Get medical help right away if you have any very serious side effects, including: slow/shallow breathing, unusual drowsiness/difficulty waking up. A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor right away if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior such as signs of depression, suicidal thoughts/attempts, thoughts about harming yourself. 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/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using midazolam, tell your doctor or pharmacist if you are allergic to it; or to other benzodiazepines (such as diazepam, lorazepam); 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, especially of: glaucoma, heart failure, kidney disease, liver disease, breathing problems (such as chronic obstructive lung disease-COPD, sleep apnea), personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol). This drug may make you dizzy, drowsy, or affect your memory. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. However, since untreated seizures are a serious condition that can harm both a pregnant woman and her unborn baby, do not stop using this medication unless directed by your doctor. Tell the doctor right away if you notice withdrawal symptoms (such as shaking, diarrhea, vomiting, trouble feeding) in your newborn. If you are planning pregnancy, become pregnant, or think you may be pregnant, discuss with your doctor right away the benefits and risks of using this medication during pregnancy. This drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: See also Warning section. 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. Some products that may interact with this drug are: conivaptan, delavirdine, HIV protease inhibitors (such as atazanavir, ritonavir), sodium oxybate. The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is used with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are using other products such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine). Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: confusion, slow/shallow breathing, coma.

NOTES: Do not share this medication with others. Sharing it is against the law.

MISSED DOSE: Not applicable.

STORAGE: Store at room temperature away from light and moisture. Do not remove the nasal spray from the package until you are ready to use it. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

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