Clobazam is used to help control seizures (convulsions) that occur with Lennox-Gastaut syndrome (LGS). It works in the brain to prevent seizures. This medicine will not cure LGS and will only control seizures for as long as you continue to take it.

Clobazam is a benzodiazepine. Benzodiazepines belong to the group of medicines called central nervous system (CNS) depressants, which are medicines that slow down the nervous system.

This medicine is available only with your doctor's prescription.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide and patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.

You may take the medicine with or without food.

Place the whole film on top of your tongue. Do not take any liquid when using this medicine. Do not chew, spit, or talk while the film dissolves. If you need a second film, wait until the first film dissolves before using a second film.

You may swallow the tablet whole or break it in half along the score. If you are unable to swallow the tablet, it may be crushed and mixed in applesauce.

Shake the oral liquid before each dose. Use the bottle adapter and dosing syringe in the package to measure the right dose. Wash the syringe after each use and air dry. Do not put the syringe in the dishwasher.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Difficulty with swallowing

fever

shakiness and unsteady walk

unsteadiness, trembling, or other problems with muscle control or coordination

Less common

Change in speech pattern

restlessness

slurred speech

trouble sitting still

trouble speaking

Incidence not known

Agitation

black, tarry stools

bleeding gums

blistering, peeling, or loosening of the skin

blood in the urine or stools

chest pain

chills

confusion as to time, place, or person

cough

diarrhea

difficult or troubled breathing

holding false beliefs that cannot be changed by fact

irregular, fast or slow, or shallow breathing

itching

joint or muscle pain

lack of feeling or emotion

painful or difficult urination

pale or blue lips, fingernails, or skin

pinpoint red spots on the skin

rash, hives, or welts

red skin lesions, often with a purple center

red, irritated eyes

seeing, hearing, or feeling things that are not there

sore throat

sores, ulcers, or white spots in the mouth or on the lips

swollen glands

troubled breathing with exertion

unusual bleeding or bruising

unusual excitement, nervousness, or restlessness

unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Aggressive

body aches or pain

decreased appetite

difficulty having a bowel movement

drooling

ear congestion

irritability

loss of voice

nasal congestion

runny nose

sleepiness or unusual drowsiness

sneezing

vomiting

Less common

Bladder pain

cloudy urine

cough with mucus

frequent urge to urinate

increased appetite

lower back or side pain

Incidence not known

Double vision

full or bloated feeling

headache

muscle spasms

pressure in the stomach

red skin

swelling of the stomach area

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, and colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop using this medicine. Check with your doctor or dentist before taking any of these medicines with clobazam.

This medicine may cause some people to be dizzy, drowsy, or less alert than normal. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Do not suddenly stop taking this medicine without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent a possible worsening of your seizures and reduce the possibility of withdrawal symptoms such as headache, nausea, irritability, tremors, or trouble sleeping.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills with this medicine.

If you or your child develop any unusual or strange thoughts and behavior while taking this medicine, be sure to discuss it with your doctor. Some of the changes that have occurred in people taking this medicine are like those seen in people who drink too much alcohol. Clobazam may cause confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

Birth control pills may not work as well while you are using this medicine. To keep from getting pregnant, use another form of birth control together with your birth control pills during therapy and for 28 days after you take the last dose.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.