LURASIDONE HYDROCHLORIDE- lurasidone hydrochloride tablet, film coated 
American Health Packaging

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MEDICATION GUIDE

8474721/0423F

Lurasidone Hydrochloride (loo-RAS-i-done HYE-droe-KLOR-ide) tablets

What is the most important information I should know about lurasidone hydrochloride tablets?
Lurasidone hydrochloride tablets may cause serious side effects, including:

How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?

Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

What is Lurasidone hydrochloride tablets?
Lurasidone hydrochloride tablets is a prescription medicine used:

It is not known if Lurasidone hydrochloride tablets are safe and effective in children:

Do not take lurasidone hydrochloride tablets if you are:

Before taking lurasidone hydrochloride tablets, tell your healthcare provider about all of your medical conditions, including if you:

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Lurasidone hydrochloride tablets and other medicines may affect each other causing possible serious side effects.

Lurasidone hydrochloride tablets may affect the way other medicines work, and other medicines may affect how lurasidone hydrochloride tablets works.

Your healthcare provider can tell you if it is safe to take lurasidone hydrochloride tablets with your other medicines. Do not start or stop any other medicines during treatment with lurasidone hydrochloride tablets without talking to your healthcare provider first.

Know the medicines you take. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine.

How should I take lurasidone hydrochloride tablets?

What should I avoid while taking lurasidone hydrochloride tablets?

What are the possible side effects of lurasidone hydrochloride tablets?
Lurasidone hydrochloride tablets may cause serious side effects, including:

Call your healthcare provider if you have any of these symptoms of high blood sugar during treatment with lurasidone hydrochloride tablets:

Low white blood cell count. Your healthcare provider may do blood tests during the first few months of treatment with lurasidone hydrochloride tablets.

Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint when you rise too quickly from a sitting or lying position.

Falls. Lurasidone hydrochloride tablets may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position (orthostatic hypotension), and can slow your thinking and motor skills which may lead to falls that can cause fractures or other injuries.

Seizures (convulsions)

Difficulty swallowing

The most common side effects of lurasidone hydrochloride tablets include:

  1. nausea
  2. weight gain
  3. problems sleeping (insomnia)

These are not all of the possible side effects of lurasidone hydrochloride tablets.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store lurasidone hydrochloride tablets?

General information about the safe and effective use of lurasidone hydrochloride tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use lurasidone hydrochloride tablets for a condition for which it was not prescribed. Do not give lurasidone hydrochloride tablets 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 lurasidone hydrochloride tablets that is written for health professionals.

What are the ingredients in lurasidone hydrochloride tablets?
Active ingredient: lurasidone hydrochloride
Inactive ingredients: mannitol, lactose monohydrate, pregelatinized starch, croscarmellose sodium, povidone, anhydrous citric acid, magnesium stearate, hypromellose, titanium dioxide and Polyethylene glycol. Additionally, the 80 mg tablet contains yellow ferric oxide and FD&C Blue No. 1 Aluminum Lake.

All brand names listed are the registered trademarks of their respective owners and are not trademarks of Alkem Laboratories Ltd.

For more information about the drug product, call 1-877-272-7901.
For more information about the packaging or labeling, call American Health Packaging at 1‐800‐707‐4621.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Distributed by:
American Health Packaging
Columbus, OH 43217

8474721/0423F

Revised: 4/2024
American Health Packaging