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MEDICATION GUIDE
TRANXENE ® (TRAN-zeen) T-Tab ®
(clorazepate dipotassium) Tablets, 
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What is the most important information I should know about TRANXENE?
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Do not stop taking TRANXENE without first talking to your healthcare provider.
Stopping TRANXENE suddenly can cause serious side effects.
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TRANXENE 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.
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TRANXENE 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 TRANXENE affects you.
- Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking TRANXENE without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, TRANXENE may make your sleepiness or dizziness much worse.
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TRANXENE can cause abuse and dependence.
- Do not stop taking TRANXENE all of a sudden. Stopping TRANXENE suddenly can cause seizures that do not stop (status epilepticus), hearing or seeing things that are not there (hallucinations), shaking, nervousness, and stomach and muscle cramps.
- Talk to your healthcare provider about slowly stopping TRANXENE to avoid withdrawal symptoms.
- Physical dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical dependence and drug addiction.
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TRANXENE is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep TRANXENE in a safe place to prevent misuse and abuse. Selling or giving away TRANXENE may harm others, and is against the law. Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.
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TRANXENE may harm your unborn or developing baby. Medicines like TRANXENE can cause birth defects. Talk with your healthcare provider if you are pregnant or plan to become pregnant. Tell your healthcare provider right away if you become pregnant while taking TRANXENE. Your healthcare provider should decide if you will take TRANXENE while you are pregnant. Birth defects may occur even in children born to women who are not taking any medicines and do not have other risk factors.
- If you become pregnant while taking TRANXENE, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can register by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.
- TRANXENE can pass into breast milk. Talk to your healthcare provider about the best way to feed your baby if you take TRANXENE. You and your healthcare provider should decide if you will take TRANXENE or breastfeed. You should not do both.
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Like other antiepileptic drugs, TRANXENE may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.
Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
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- thoughts about suicide or dying
- attempts to commit suicide
- new or worse depression
- new or worse anxiety
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- feeling agitated or restless
- panic attacks
- trouble sleeping (insomnia)
- new or worse irritability
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- acting aggressive, being angry, or violent
- acting on dangerous impulses
- an extreme increase in activity and talking (mania)
- other unusual changes in behavior or mood
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How can I watch for early symptoms of suicidal thoughts and actions?
- Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
- Keep all follow-up visits with your healthcare provider as scheduled.
Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).
Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.
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What is TRANXENE?
TRANXENE is a prescription medicine used:
- to treat anxiety disorders
- with other medicines to treat partial seizures
- to treat the symptoms of sudden alcohol withdrawal
It is not known if TRANXENE is safe and effective in children less than 9 years of age.
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Do not take TRANXENE if you:
- are allergic to clorazepate dipotassium or any of the ingredients in TRANXENE. See the end of this Medication Guide for a complete list of ingredients in TRANXENE.
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Before you take TRANXENE, tell your healthcare provider about all your medical conditions, including if you:
- have liver or kidney problems
- have or have had depression, mood problems, or suicidal thoughts or behavior
- have a history of abnormal thinking and behavior (psychotic reactions)
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Taking TRANXENE with certain other medicines can cause side effects or affect how well TRANXENE or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.
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How should I take TRANXENE?
- Take TRANXENE exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you how much TRANXENE to take and when to take it.
- Your healthcare provider may change your dose if needed. Do not change your dose of TRANXENE without talking to your healthcare provider.
- Do not stop taking TRANXENE without first talking to your healthcare provider. Stopping TRANXENE suddenly can cause serious problems.
- If you take too much TRANXENE, call your healthcare provider or go to the nearest hospital emergency room right away.
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What are the possible side effects of TRANXENE?
TRANXENE may cause serious side effects, including: See“What is the most important information I should know about TRANXENE?”
The most common side effects of TRANXENE include:
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- upset stomach
- blurred vision
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These are not all the possible side effects of TRANXENE. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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How should I store TRANXENE?
- Store TRANXENE between 68ºF to 77ºF (20ºC to 25ºC).
- Keep TRANXENE tablets in a tightly closed container, dry, and out of the light.
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Keep TRANXENE and all medicines out of the reach of children.
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General Information about the safe and effective use of TRANXENE.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use TRANXENE for a condition for which it was not prescribed. Do not give TRANXENE 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 TRANXENE that is written for health professionals.
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What are the ingredients in TRANXENE?
Active ingredient: clorazepate dipotassium
Inactive ingredients: colloidal silicon dioxide, magnesium oxide, magnesium stearate, microcrystalline cellulose, potassium carbonate, potassium chloride and talc
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Manufactured by: UPM Pharmaceuticals, Bristol, TN 37620
For: Recordati Rare Diseases Inc.
TRANXENE is a registered trademark of Recordati Rare Diseases Inc.
T-TAB is a registered trademark of Lundbeck LLC.
For more information about TRANXENE, go to www.recordatirarediseases.com
or call Recordati Rare Diseases Inc. at 1- 888-575-8344.
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