Uses of Tranxene-T:

• It is used to treat alcohol withdrawal.
• It is used to treat anxiety.
• It is used to treat seizures.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Tranxene-T?

For all patients taking Tranxene-T (clorazepate):

• If you have an allergy to clorazepate or any other part of Tranxene-T (clorazepate).
• If you are allergic to Tranxene-T (clorazepate); any part of Tranxene-T (clorazepate); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have glaucoma.
• If you have low mood (depression) or another mental problem.
• If you are breast-feeding. Do not breast-feed while you take Tranxene-T (clorazepate).

Children:

• If your child is younger than 9 years of age. Do not give Tranxene-T (clorazepate) to a child younger than 9 years of age.

This is not a list of all drugs or health problems that interact with Tranxene-T (clorazepate).

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 Tranxene-T (clorazepate) 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 Tranxene-T?

• Tell all of your health care providers that you take Tranxene-T (clorazepate). 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 Tranxene-T (clorazepate) affects you.
• Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
• Have your blood work checked if you are on Tranxene-T (clorazepate) for a long time. Talk with your doctor.
• This medicine may be habit-forming with long-term use.
• Do not change the dose or stop Tranxene-T (clorazepate). This could cause seizures. Talk with your doctor.
• Do not stop taking Tranxene-T (clorazepate) all of a sudden without calling your doctor. You may have a greater risk of signs of withdrawal. If you need to stop Tranxene-T (clorazepate), you will want to slowly stop it as ordered by your doctor.
• If you are 65 or older, use Tranxene-T (clorazepate) with care. You could have more side effects.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant, especially in the first trimester.
• If you are pregnant or you get pregnant while taking Tranxene-T (clorazepate), call your doctor right away.

How is this medicine (Tranxene-T) best taken?

Use Tranxene-T (clorazepate) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food. Take with food if it causes an upset stomach.

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:

For all uses of Tranxene-T (clorazepate):

• 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.
• Change in eyesight.
• Change in balance.
• Feeling confused.
• Feeling very tired or weak.
• Not able to pass urine or change in how much urine is passed.
• Slurred speech.
• Shakiness.
• Not able to sleep.
• Very bad dizziness or passing out.
• Patients who take Tranxene-T (clorazepate) may be at a greater risk of having thoughts or actions of suicide. The risk may be greater in people who have had these thoughts or actions in the past. Call the doctor right away if signs like low mood (depression), nervousness, restlessness, grouchiness, panic attacks, or changes in mood or actions are new or worse. Call the doctor right away if any thoughts or actions of suicide occur.

For seizures:

• If seizures are worse or not the same after starting Tranxene-T (clorazepate).

What are some other side effects of Tranxene-T?

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.
• Dizziness.
• Headache.
• Upset stomach.
• Dry mouth.
• Feeling tired or weak.

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 Tranxene-T?

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

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.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time Tranxene-T (clorazepate) is refilled. If you have any questions about Tranxene-T (clorazepate), 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.