Clobazam Dissolving Film

What is this medication?

CLOBAZAM (KLOH bay zam) prevents and controls seizures in people with epilepsy. It works by calming overactive nerves in your body. It belongs to a group of medications called benzodiazepines.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Sympazan

What should I tell my care team before I take this medication?

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

• Kidney disease
• Liver disease
• Lung or breathing disease
• Mental illness
• Substance abuse or addiction
• Suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member
• An unusual or allergic reaction to clobazam, other benzodiazepines, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth. Follow the directions on the prescription label. Leave the oral film in the foil pouch until you are ready to take it. With dry hands, open the pouch and gently remove the oral film. Place the medication on the tongue and allow it to dissolve, and then swallow. Do not chew, spit, or talk while the medication dissolves. Take only 1 oral film at a time. Do not take with liquids. You can take it with or without food. If it upsets your stomach, take it with food. Take your medication at regular intervals. Do not take it more often than directed. Do not stop taking except on your care team's advice.

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

Talk to your pediatrician about the use of this medication in children. While this medication may be prescribed for children as young as 2 years for selected conditions, precautions do apply.

Patients over 65 years of age may have a stronger reaction and need a smaller dose.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

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.

What may interact with this medication?

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

• Narcotic medications for cough
• Sodium oxybate

This medication may interact with the following medications:

• Alcohol
• Antihistamines for allergy, cough, and cold
• Certain medications for anxiety or sleep
• Certain medications for depression, like amitriptyline, fluoxetine, sertraline
• Certain medications for fungal infections like ketoconazole and itraconazole
• Certain medications for seizures like phenobarbital, primidone
• Dextromethorphan
• Estrogen and/or progestin hormones
• General anesthetics like halothane, isoflurane, methoxyflurane, propofol
• Local anesthetics like lidocaine, pramoxine, tetracaine
• Medications that relax muscles for surgery
• Opioid medications
• Omeprazole
• Phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine
• Ticlopidine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Tell your care team if your symptoms do not start to get better or if they get worse.

This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Contact your care team right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips or lymph nodes in your neck or under your arms.

Do not stop taking except on your care team's advice. You may develop a severe reaction. Your care team will tell you how much medication to take. Long term use of this medication may cause your brain and body to depend on it. This can happen even when used as directed by your care team. You and your care team will work together to determine how long you will need to take this medication.

Wear a medical ID bracelet or chain, and carry a card that describes your disease and details of your medication and dosage times.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

If you are taking another medication that also causes drowsiness, you may have more side effects. Give your care team a list of all medications you use. Your care team will tell you how much medication to take. Do not take more medication than directed. Call emergency for help if you have problems breathing or unusual sleepiness.

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

Estrogen and/or progestin hormones may not work as well while you are taking this medication. If you are using this medication for contraception, talk to your care team about using a second type of contraception.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• CNS depression—slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, trouble staying awake
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Thoughts of suicide or self-harm, worsening mood, or feelings of depression

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

• Constipation
• Drowsiness
• Excessive drooling
• Fever
• Unusual weakness or fatigue

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

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

Store between 20 and 25 degrees C (68 and 77 degrees F). Keep this medication in the foil pouch until you are ready to use.

This medication may cause harm and death if it is taken by other adults, children, or pets. It is important to get rid of the medication as soon as you no longer need it or it is expired. You can do this in two ways:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.