Clorazepate Extended Release Tablets

What is this medicine?

CLORAZEPATE (klor AZ e pate) is a benzodiazepine. It is used to treat anxiety.

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take your doses at regular intervals. Do not take your medicine more often than directed. If you have been taking this medicine regularly for some time, do not suddenly stop taking it. You must gradually reduce the dose or you may get severe side effects. Ask your doctor or health care professional for advice. Even after you stop taking this medicine it can still affect your body for several days.

A special MedGuide will be given to you by the pharmacist with each new prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• confusion

• feeling faint or lightheaded, falls

• mood changes, depression, excitability or aggressive behavior

• movement difficulty, staggering or jerky movements

• muscle cramps

• restlessness

• tremors

• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• changes in vision

• dizziness, drowsiness, clumsiness, or unsteadiness, a hangover effect

• dry mouth

• headache

• stomach upset

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• itraconazole

This medicine may also interact with the following medications:

• medicines for depression, mental problems or psychiatric disturbances

• prescription pain medicines

• some medicines for seizures like carbamazepine, phenobarbital, phenytoin, primidone

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medicine?

Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.

This medicine may cause accidental overdose and death if taken by other adults, children, or pets. Mix any unused medicine with a substance like cat litter or coffee grounds. Then throw the medicine away in a sealed container like a sealed bag or a coffee can with a lid. Do not use the medicine after the expiration date.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from moisture and light.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• an alcohol or drug abuse problem

• bipolar disorder, depression, psychosis or other mental health condition

• glaucoma

• kidney disease

• liver disease

• lung or breathing disease

• myasthenia gravis

• Parkinson's disease

• seizures or a history of seizures

• suicidal thoughts

• an unusual or allergic reaction to clorazepate, other benzodiazepines, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. Your body can become dependent on this medicine. Ask your doctor or health care professional if you still need to take it.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. To reduce the risk of dizzy and fainting spells, do not stand or sit up quickly, especially if you are an older patient. Alcohol may increase dizziness and drowsiness. Avoid alcoholic drinks.

Do not treat yourself for coughs, colds or allergies without asking your doctor or health care professional for advice. Some ingredients can increase possible side effects.

The use of this medicine may increase the chance of suicidal thoughts or actions. Pay special attention to how you are responding while on this medicine. Any worsening of mood, or thoughts of suicide or dying should be reported to your health care professional right away.

Women who become pregnant while using this medicine may enroll in the North American Antiepileptic Drug Pregnancy Registry by calling 1-888-233-2334. This registry collects information about the safety of antiepileptic drug use during pregnancy.