Tranxene T-Tab is a benzodiazepine (ben-zoe-dye-AZE-eh-peen) that is used to treat anxiety disorders, partial seizures, or alcohol withdrawal symptoms.

Tranxene T-Tab may also be used for purposes not listed in this medication guide.

Tranxene T-Tab can slow or stop your breathing, especially if you have recently used an opioid medication or alcohol.

MISUSE OF Tranxene T-Tab CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep this medicine where others cannot get to it.

Do not stop using Tranxene T-Tab without asking your doctor. You may have life-threatening withdrawal symptoms if you stop using the medicine suddenly after long-term use. Some withdrawal symptoms may last up to 12 months or longer.

Get medical help right away if you stop using Tranxene T-Tab and have symptoms such as: unusual muscle movements, being more active or talkative, sudden and severe changes in mood or behavior, confusion, hallucinations, seizures, or thoughts about suicide.

Some people have thoughts about suicide while taking Tranxene T-Tab. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.

Follow the directions on your prescription label and read all medication guides or instruction sheets. Never use Tranxene T-Tab in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to use more of Tranxene T-Tab.

Never share this medicine with another person, especially someone with a history of drug addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine where others cannot get to it. Selling or giving away this medicine is against the law.

If you use Tranxene T-Tab long-term, you may need frequent medical tests.

Call your doctor if your symptoms do not improve, or if they get worse.

Do not stop using Tranxene T-Tab without asking your doctor. You may have life-threatening withdrawal symptoms if you stop using the medicine suddenly after long-term use.

Store at room temperature away from moisture, heat, and light. Keep your medicine in a place where no one can use it improperly.

You should not use Tranxene T-Tab if you are allergic to it, or if you have:

• narrow-angle glaucoma.

Tell your doctor if you have ever had:

• liver or kidney disease;

• mood problems, depression, psychosis; or

• suicidal thoughts or actions.

Some people have thoughts about suicide while taking Tranxene T-Tab. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

Tell your doctor if you are pregnant or plan to become pregnant. Tranxene T-Tab may harm an unborn baby. Avoid taking this medicine during the first trimester of pregnancy.

If you use Tranxene T-Tab during pregnancy, your baby could be born with life-threatening withdrawal symptoms, and may need medical treatment for several weeks.

If you take Tranxene T-Tab for seizures, do not start or stop taking it during pregnancy without your doctor's advice. Having a seizure during pregnancy could harm both mother and baby.

Do not breastfeed.

Not approved for use by anyone younger than 9 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of Tranxene T-Tab can be fatal if you take it with alcohol, opioid medicine, or other drugs that cause drowsiness or slow your breathing.

Overdose symptoms may include extreme drowsiness or coma.

Do not drink alcohol. Dangerous side effects could occur.

Avoid driving or hazardous activity until you know how Tranxene T-Tab will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tranxene T-Tab can slow or stop your breathing, especially if you have recently used an opioid medication or alcohol. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself.

Tranxene T-Tab may cause serious side effects. Call your doctor at once if you have:

• severe drowsiness;

• slow breathing (breathing may stop);

• confusion, paranoia, unusual thoughts or behavior;

• a seizure; or

• suicidal thoughts or actions.

Drowsiness or dizziness may last longer in older adults. Use caution to avoid falling or accidental injury.

Common side effects of Tranxene T-Tab may include:

• dizziness, drowsiness;

• blurred vision;

• upset stomach; or

• dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Taking Tranxene T-Tab with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Other drugs may affect Tranxene T-Tab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.