What is the most important information I should know about Lorazepam?

  * Lorazepam is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death. Lorazepam 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 Lorazepam affects you.
  * Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking Lorazepam without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, Lorazepam may make your sleepiness or dizziness much worse.
  * Do not take more Lorazepam than prescribed. What is Lorazepam? Lorazepam is a prescription medicine used: to treat anxiety disorders for the short-term relief of the symptoms of anxiety or anxiety that can happen with symptoms of depression Lorazepam is a federal controlled substance (C-IV) because it can be abused or lead to dependence. Keep Lorazepam in a safe place to prevent misuse and abuse. Selling or giving away Lorazepam may harm others, and is against the law. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines or street drugs. It is not known if Lorazepam is safe and effective in children less than 12 years of age. It is not known if Lorazepam is safe and effective for use for longer than 4 months. Do not take Lorazepam if you: are allergic to lorazepam, other benzodiazepines, or any of the ingredients in Lorazepam . See the end of this Medication Guide for a complete list of ingredients in Lorazepam Before you take Lorazepam , tell your healthcare provider about all of your medical conditions, including if you: have or have had depression, mood problems, or suicidal thoughts or behavior have a history of drug or alcohol abuse or addiction have lung disease or breathing problems (such as COPD, sleep apnea syndrome) have liver or kidney problems have or have had seizures are pregnant or plan to become pregnant. Lorazepam may harm your unborn baby. You and your healthcare provider should decide if you should take Lorazepam while you are pregnant. are breastfeeding or plan to breastfeed. Lorazepam passes into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take Lorazepam . You should not breastfeed while taking Lorazepam Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking Lorazepam with certain other medicines can cause side effects or affect how well Lorazepam or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.
  * How should I take Lorazepam? Take Lorazepam exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you how much Lorazepam to take and when to take it. If you take too much Lorazepam , call your healthcare provider or go to the nearest hospital emergency room right away.
  * What should I avoid while taking Lorazepam? Lorazepam can cause you to be drowsy. Do not drive a car or operate heavy machinery until you know how Lorazepam affects you. You should not drink alcohol while taking Lorazepam . Drinking alcohol can increase your chances of having serious side effects. What are the possible side effects of Lorazepam? Lorazepam may cause serious side effects, including: See “What is the most important information I should know about Lorazepam?” Depression. Pre-existing depression may emerge or worsen during use of benzodiazepines including Lorazepam . Abuse and dependence. Taking Lorazepam can cause physical and psychological dependence. Physical and psychological dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction. Withdrawal symptoms. You may have withdrawal symptoms if you stop taking Lorazepam suddenly. Withdrawal symptoms can be serious and include seizures. Mild withdrawal symptoms include a depressed mood and trouble sleeping. Talk to your healthcare provider about slowly stopping Lorazepam to avoid withdrawal symptoms. The most common side effects of Lorazepam include: sedation dizziness weakness unsteadiness These are not all the possible side effects of Lorazepam . Call your doctor for medical advice about side effects.
  * You may report side effects to FDA at 1-800-FDA-1088 or LEADING PHARMA, LLC AT 1-844-740-7500. How should I store Lorazepam? Store Lorazepam in a tightly closed container at 77°F (25°C); excursions permitted to 59° to 86°F (15° to 30°C). Keep Lorazepam and all medicines out of the reach of children. General information about the safe and effective use of Lorazepam. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Lorazepam for a condition for which it was not prescribed. Do not give Lorazepam to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Lorazepam that is written for health professionals What are the ingredients in Lorazepam?
  * Active ingredient: lorazepam Inactive ingredients: lactose anhydrous, magnesium stearate, microcrystalline cellulose, and polacrilin potassium. Manufactured by: Leading Pharma, LLC Fairfield, NJ 07004 Rev. 01 09/18



Revised: 10/2024

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Version: 4

Effective Time: 20241008

NuCare Pharmaceuticals, Inc.