When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to chlordiazepoxide, amitriptyline, or similar medicines.

How to Use This Medicine:
Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Drink extra fluids so you will urinate more often and help prevent kidney problems.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you have used an MAO inhibitor within the past 14 days.
• Some foods and medicines can affect how this medicine works. Tell your doctor if you are using any of the following:
  
  • Cimetidine, guanethidine, topiramate
  • Medicine for heart rhythm problem (including flecainide, propafenone, quinidine)
  • Other medicine to treat depression (including fluoxetine, paroxetine, sertraline)
  • Phenothiazine medicine (including chlorpromazine, prochlorperazine, promethazine, thioridazine)
• Do not drink alcohol while you are using this medicine.
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding, or if you have kidney disease, liver disease, heart or blood vessel disease, an overactive thyroid, or a history of glaucoma, seizures, or trouble urinating. Tell your doctor if you have a recent heart attack.
• This medicine may increase depression or thoughts of suicide. Tell your doctor right away if you start to feel more depressed or think about hurting yourself.
• This medicine may cause the following problems:
  
  • Changes in heart rhythm (including arrhythmia)
  • Heart attack or stroke
• This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• Tell any doctor or dentist who treats you that you are using this medicine. You may need to stop using this medicine several days before you have surgery or medical tests.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate, trouble urinating
• Changes in behavior, unusual thoughts of hurting yourself or others, trouble sleeping
• Chest pain that may spread to your arms, jaw, back, or neck, trouble breathing, nausea, unusual sweating, faintness
• Fast, pounding, or uneven heartbeat
• Seizures or tremors

If you notice these less serious side effects, talk with your doctor:

• Blurred vision
• Constipation
• Dizziness or drowsiness
• Dry mouth

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088