Uses of Loxapine Capsules:

• It is used to treat schizophrenia.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Loxapine Capsules?

• If you have an allergy to loxapine or any other part of this medicine (loxapine capsules).
• If you are allergic to this medicine (loxapine capsules); any part of this medicine (loxapine capsules); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are very sleepy.
• If you have recently drunk a lot of alcohol or taken a big amount of drugs that may slow your actions like phenobarbital or some pain drugs like oxycodone.

This is not a list of all drugs or health problems that interact with this medicine (loxapine capsules).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (loxapine capsules) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Loxapine Capsules?

• Tell all of your health care providers that you take this medicine (loxapine capsules). This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine (loxapine capsules) affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Avoid drinking alcohol while taking this medicine (loxapine capsules).
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Low white blood cell counts have happened with drugs like this one. This may lead to a higher chance of infection. Rarely, infections have been deadly. Tell your doctor if you have ever had a low white blood cell count. Call your doctor right away if you have signs of infection like fever, chills, or sore throat.
• Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
• Have an eye exam as you have been told by your doctor.
• Dizziness, sleepiness, and feeling less stable may happen with this medicine (loxapine capsules). These may lead to falling, which can cause broken bones or other health problems.
• Older adults with dementia taking drugs like this one have had a higher number of strokes. Sometimes these have been deadly. This medicine is not approved to treat mental problems caused by dementia.
• If you are 65 or older, use this medicine (loxapine capsules) with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine (loxapine capsules) while you are pregnant.
• Taking this medicine (loxapine capsules) in the third trimester of pregnancy may lead to uncontrolled muscle movements and withdrawal in the newborn.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Loxapine Capsules) best taken?

Use this medicine (loxapine capsules) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.
• Keep using this medicine (loxapine capsules) as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking.
• Shakiness, trouble moving around, or stiffness.
• Very bad dizziness or passing out.
• A fast heartbeat.
• Very bad headache.
• Feeling confused.
• Change in eyesight, eye pain, or very bad eye irritation.
• Seizures.
• Trouble passing urine.
• Slurred speech.
• Feeling very tired or weak.
• Any unexplained bruising or bleeding.
• Enlarged breasts.
• Nipple discharge.
• Not able to get or keep an erection.
• For women, no period.
• Restlessness.
• A very bad and sometimes deadly health problem called neuroleptic malignant syndrome (NMS) may happen. Call your doctor right away if you have any fever, muscle cramps or stiffness, dizziness, very bad headache, confusion, change in thinking, fast heartbeat, heartbeat that does not feel normal, or are sweating a lot.
• Some people may get a severe muscle problem called tardive dyskinesia. This problem may lessen or go away after stopping this medicine (loxapine capsules), but it may not go away. The risk is greater with diabetes and in older adults, especially older women. The risk is greater with longer use or higher doses, but it may also occur after short-term use with low doses. Call your doctor right away if you have trouble controlling body movements or problems with your tongue, face, mouth, or jaw like tongue sticking out, puffing cheeks, mouth puckering, or chewing.

What are some other side effects of Loxapine Capsules?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling sleepy.
• Trouble sleeping.
• Dry mouth.
• Constipation.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Loxapine Capsules?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine (loxapine capsules) is refilled. If you have any questions about this medicine (loxapine capsules), please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.