Clobazam is a benzodiazepine (ben-zoe-dye-AZE-eh-peen) that is used with other medications to treat seizures caused by Lennox-Gastaut syndrome, in people who are at least 2 years old.

Clobazam may also be used for purposes not listed in this medication guide.

Clobazam can slow or stop your breathing, especially if you have recently used an opioid medication or alcohol.

MISUSE OF clobazam CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

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

Get emergency medical help if you have a severe skin reaction (skin pain, skin rash with blistering).

Do not stop using clobazam without asking your doctor. You may have increased seizures or 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 clobazam 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.

Clobazam comes as a tablet and a suspension (liquid) to take by mouth, and as a film to apply on the tongue. It is usually taken once or twice a day, with or without food. Take clobazam at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.

If you are unable to swallow the tablets whole, you may break them in half on the score mark or crush and mix them with a small amount of applesauce.

The liquid comes an adapter and two oral dosing syringes. Use only one of the two oral dosing syringes to measure your dose and save the second syringe. If the first oral syringe is damaged or lost, the second provided syringe may be used as a replacement.

To take the liquid, follow these steps:

1. Before the first use, uncap the bottle and firmly insert the adapter into the neck of the bottle until the adapter top is even with the bottle top. Do not remove the adapter during the period of time you are using this bottle.
2. Shake the liquid well before each use to mix the medication evenly.
3. To measure your dose, push the plunger of the syringe all the way down and insert the syringe into the adapter of the upright bottle. Then turn the bottle upside down and slowly pull the plunger back until the black ring is in line with your prescribed dose.
4. Remove the syringe from the bottle adapter and slowly squirt the liquid from the syringe into the corner of your mouth.
5. Place the bottle cap over the adapter after each use.
6. Wash the oral syringe after each use. To wash the syringe, remove the plunger completely, wash the barrel and plunger with soap and water, rinse, and allow to dry. Do not place the syringe parts in the dishwasher.

To take the film, follow these steps:

1. Open the foil pouch and remove the film. Be sure that your hands are dry and clean.
2. Place the film on the top of your tongue.
3. Close your mouth and swallow your saliva normally. Do not chew, spit, or talk while the film dissolves. Do not take with liquids.
4. Wash your hands.

If your doctor has told you to take more than one film per dose, wait until the first film has completely dissolved before applying the second film.

Your doctor will probably start you on a low dose of clobazam and gradually increase your dose, not more than once every week.

Some people may respond differently to clobazam based on their heredity or genetic makeup. Your doctor may order a blood test to help find the dose of clobazam that is best for you.

Clobazam may help control your condition but will not cure it. Continue to take clobazam even if you feel well. Do not stop taking clobazam without talking to your doctor.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with clobazam and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

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

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.

You may take clobazam with or without food.

If you cannot swallow a tablet whole, break it in half or crush it and mix the medicine into a spoonful of applesauce. Swallow the mixture right away without chewing. Do not save it for later use.

Shake the oral suspension (liquid). Measure a dose with the supplied measuring device (not a kitchen spoon).

Place the oral film on top of your tongue and allow it to dissolve.

Doses are based on weight in children and teenagers. Your child's dose may change if the child gains or loses weight.

Seizures may increase if you stop using clobazam suddenly. Do not stop using clobazam 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 and heat. Keep your medicine in a place where no one can use it improperly.

Throw away any unused oral suspension 90 days after you first opened the bottle.

You should not take clobazam if you are allergic to it.

Tell your doctor if you have ever had:

• breathing problems or lung disease;

• depression, mood problems, or suicidal thoughts or behavior;

• a drug or alcohol addiction; or

• liver or kidney disease.

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

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

Do not start or stop seizure medication during pregnancy without your doctor's advice. Clobazam may harm an unborn baby, but having a seizure during pregnancy could harm both mother and baby. Preventing seizures may outweigh these risks. Tell your doctor right away if you become pregnant.

There may be other seizure medications that are safer to use during pregnancy.

Clobazam can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. Use a back-up barrier birth control to prevent pregnancy: condom, diaphragm, cervical cap, or contraceptive sponge. Keep using birth control for at least 28 days after your last dose of clobazam.

If you are breastfeeding, tell your doctor if you notice drowsiness or feeding problems in the nursing baby.

Not approved for use by anyone younger than 2 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 clobazam 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 weakness, confusion, slow breathing, or loss of consciousness.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Do not open the foil pouch for the film until right before you are ready to use it. Store clobazam in a safe place so that no one else can take it accidentally or on purpose. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Store clobazam suspension (liquid) in an upright position. Do not use any remaining liquid more than 90 days after first opening the bottle.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Avoid drinking alcohol. Dangerous side effects or death could occur.

Avoid driving or hazardous activity until you know how clobazam 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, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Clobazam 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.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Clobazam may cause serious side effects. Call your doctor at once if you have:

• weak or shallow breathing;

• severe drowsiness, feeling like you might pass out; or

• problems with balance or muscle movement.

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

Common side effects of clobazam may include:

• drowsiness, tiredness, trouble sleeping;

• slurred speech;

• anger, aggression;

• constipation;

• painful urination;

• fever, cough, breathing problems; or

• drooling.

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 clobazam 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 clobazam, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Clobazam is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.