• VALTOCO is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system (CNS) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma, and death. Get emergency medical help right away if any of the following happens:
  • shallow or slowed breathing
  • breathing stops (which may lead to the heart stopping)
  • excessive sleepiness (sedation)
  Do not drive or operate heavy machinery until you know how taking VALTOCO with opioids affects you.

• Risk of abuse, misuse, and addiction. There is a risk for abuse, misuse, and addiction with benzodiazepines, including VALTOCO, which can lead to overdose and serious side effects including coma and death.
  • Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including diazepam (the active ingredient in VALTOCO). These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects.
  • You can develop an addiction even if you use VALTOCO as prescribed by your healthcare provider.
  • Use VALTOCO exactly as your healthcare provider prescribed.
  • Do not share your VALTOCO with other people.
  • Keep VALTOCO in a safe place and away from children.

• Physical dependence and withdrawal reactions. Benzodiazepines, including VALTOCO, can cause physical dependence and withdrawal reactions, especially if you use VALTOCO daily. VALTOCO is not intended for daily use.
  • Do not suddenly stop using VALTOCO without talking to your healthcare provider. Stopping VALTOCO suddenly can cause serious and life-threatening side effects, including, unusual movements, responses, or expressions, seizures, sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these symptoms.
  • Some people who suddenly stop benzodiazepines have symptoms that can last for several weeks to more than 12 months, including, anxiety, trouble remembering, learning, or concentrating, depression, problems sleeping, feeling like insects are crawling under your skin, weakness, shaking, muscle twitching, burning or prickling feeling in your hands, arms, legs or feet, and ringing in your ears.
  • Physical dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical dependence and drug addiction.
  • Do not use more VALTOCO than prescribed or use VALTOCO more often than prescribed.

• VALTOCO can make you sleepy or dizzy and can slow your thinking and motor skills.
  • Do not drive, operate heavy machinery, or do other dangerous activities until you know how VALTOCO affects you.
  • Do not drink alcohol or take other drugs that may make you sleepy or dizzy while using VALTOCO without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, VALTOCO may make your sleepiness or dizziness worse.

• Like other antiepileptic medicines, VALTOCO may cause suicidal thoughts or actions in a small number of people, about 1 in 500. Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

Do not use VALTOCO if you:

• have asthma, emphysema, bronchitis, chronic obstructive pulmonary disease, or other breathing problems.
• have a history of alcohol or drug abuse.
• have a history of depression, mood problems or suicidal thoughts or behaviors.
• have liver or kidney problems.
• are pregnant or plan to become pregnant.
  • Taking VALTOCO late in pregnancy may cause your baby to have symptoms of sedation (breathing problems, sluggishness, low muscle tone) and/or withdrawal symptioms (jitteriness, irritability, restlessness, shaking, excessive crying, feeding problems).
  • Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with VALTOCO.
  • If you become pregnant while using VALTOCO, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. You can register by calling 1-888-233-2334. For more information about the registry, go to http://www.aedpregnancyregistry.org. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.
• are breastfeeding or plan to breastfeed. VALTOCO passes into your breast milk and may harm your baby.
  • Breatfeeding during treatment with VALTOCO may cause your baby to have sleepiness, feeding problems, and decreased weight gain.
  • Talk to your healthcare provider about the best way to feed your baby if you use VALTOCO.

• Read the Instructions for Use that comes with this Medication Guide for detailed information about the right way to use VALTOCO.
• Use VALTOCO exactly as prescribed by your healthcare provider.
• Your healthcare provider will tell you:
  • what seizure clusters are
  • exactly how much VALTOCO to give
  • when to give VALTOCO
  • how to give VALTOCO
  • what to do after you give VALTOCO if the seizures do not stop or there is a change in breathing, behavior, or condition that worries you
• You should carry VALTOCO with you in case you need it to control your seizure clusters.
• Family members, care providers, and other people who may have to give VALTOCO should know where you keep your VALTOCO and how to give VALTOCO before a seizure cluster happens.
• VALTOCO is given in the nose (nasal) only.
• VALTOCO comes ready to use.
• Each VALTOCO only sprays 1 time and cannot be reused. Do not test or prime the nasal spray before use.
• Each dose of VALTOCO is provided in an individual pack. Use all of the medicine in 1 pack for a complete dose.

• Stay with the person after you give VALTOCO and watch them closely.
• Make a note of the time VALTOCO was given.
• Call for emergency help if any of the following happen:
  • seizure cluster behavior is different than other seizure clusters the person has had.
  • you are alarmed by how often the seizures happen, by how severe the seizure is, by how long the seizure lasts, or by the color or breathing of the person.
• Throw away (discard) the used VALTOCO.

• See "What is the most important information I should know about VALTOCO?"
• Increase in eye pressure in people with open-angle glaucoma. See "Do not use VALTOCO if you:"