Clobazam Oral Film (CLOBAZAM FILM - ORAL)

Instructions

Do not use if the pouch containing the medicine is torn or damaged.

Remove medicine from the foil just before using. Place the sheet on top of your tongue and let it dissolve completely. After it has dissolved, swallow it with saliva.

Only use 1 sheet at a time.

Do not cut the sheet.

Do not chew or swallow it whole.

Do not talk, chew, or spit after placing the medicine on your tongue.

Avoid eating food or drinking liquids until the medicine has dissolved completely.

Wash your hands before and after handling this medicine.

This medicine will work best if you take it at about the same time every day.

Store at room temperature away from heat, light, and moisture. Do not keep in the bathroom.

Please ask your doctor, nurse, or pharmacist how to discard unused medicines safely.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you forget to take a dose on time, take it as soon as you remember. If it is almost time for the next dose, do not take the missed dose. Return to your normal schedule. Do not take 2 doses at one time.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Contact your doctor if your seizures do not improve or worsen while on this medicine.

If you need to stop this medicine, your doctor may wish to gradually reduce the dosage before stopping.

This medicine may decrease the effectiveness of some birth controls which use hormones (such as birth control pills and patches). Use an extra form of birth control, such as condoms, while on this medicine.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

Though it helps many people, this medicine may sometimes cause addiction, especially if it is used for a long time. This risk for addiction may be higher if you have a substance use disorder - such as overuse of or addiction to drugs or alcohol. Speak with your doctor about the benefits and risks of using this medicine.

If you stop this medicine suddenly, after using it regularly for a long time, you may have withdrawal symptoms. Your doctor may ask you to slowly reduce your dose before stopping it. Tell your doctor right away if you notice any symptoms of withdrawal. Withdrawal symptoms can include headaches, restlessness, hallucinations, confusion, depression, nausea, or seizures.

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Do not use the medication any more than instructed.

If possible, avoid using with alcohol, marijuana, or other medicines that can cause dizziness or drowsiness. These include allergy/cold products, muscle relaxers, sleep aids, and pain relievers.

Your ability to stay alert or to react quickly may be impaired by this medicine. Do not drive or operate machinery until you know how this medicine will affect you.

This medicine passes into breast milk. Ask your doctor before breastfeeding.

This medicine can hurt a new baby in the womb. If you become pregnant while on this medicine, tell your doctor immediately. Your doctor may switch you to a different medicine.

Always carry an ID card or wear a medical alert bracelet indicating your medical condition.

Use medicine with caution if you have breathing problems. Get help right away for slow or shallow breathing.

Do not share this medicine with anyone who has not been prescribed this medicine.

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

Always refill this medicine before it runs out.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• agitated feeling or trouble sleeping
• constipation
• dizziness or drowsiness
• drooling
• lack of energy and tiredness

If you have any of the following side effects, you may be getting too much medicine. Please contact your doctor to let them know about these side effects.

• decreased awareness or responsiveness
• loss of balance
• shallow, irregular breathing
• confusion
• shortness of breath

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• changes in memory, mood, or thinking
• depression or feeling sad
• fainting
• fever
• memory problems or loss
• mouth sores or irritation
• muscle weakness
• nervousness
• red, peeling or blistering skin
• slurred speech
• suicidal thoughts
• swelling in the neck or throat
• unusual or unexplained tiredness or weakness
• difficulty or discomfort urinating

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.