ONFI- clobazam tablet 
ONFI- clobazam suspension 
Lundbeck LLC

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MEDICATION GUIDE
ONFI® (ON-fee)
(clobazam)
Tablets and Oral Suspension

Read this Medication Guide before you start taking ONFI and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is the most important information I should know about ONFI?

Do not stop taking ONFI without first talking to your healthcare provider. Stopping ONFI suddenly can cause serious problems.

ONFI can cause serious side effects, including:

1. ONFI can make you sleepy or dizzy, slow your thinking, and make you clumsy which may get better over time.

2. ONFI can cause withdrawal symptoms.

3. ONFI can be abused and cause dependence.

ONFI is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep ONFI in a safe place to prevent misuse and abuse. Selling or giving away ONFI may harm others, and is against the law. Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.

4. Serious skin reactions have been seen with ONFI and may require stopping its use. Do not stop taking ONFI without first talking to your healthcare provider.

5. Like other antiepileptic drugs, ONFI may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

How can I watch for early symptoms of suicidal thoughts and actions?

Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

What is ONFI?

ONFI is a prescription medicine used along with other medicines to treat seizures associated with Lennox-Gastaut syndrome in people 2 years of age or older.

It is not known if ONFI is safe and effective in children less than 2 years old.

What should I tell my healthcare provider before taking ONFI?

Before you take ONFI, tell your healthcare provider if you:

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Taking ONFI with certain other medicines can cause side effects or affect how well ONFI or the other medications work. Do not start or stop other medicines without talking to your healthcare provider.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take ONFI?

What should I avoid while taking ONFI?

What are the possible side effects of ONFI?

ONFI may cause serious side effects, including:

See "What is the most important information I should know about ONFI?"

The most common side effects of ONFI include:

These are not all the possible side effects of ONFI. For more information, ask your healthcare provider or pharmacist.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

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

How should I store ONFI?

Tablets

Oral Suspension

Keep ONFI and all medicines out of the reach of children.

General Information about the safe and effective use of ONFI.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ONFI for a condition for which it was not prescribed. Do not give ONFI to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about ONFI. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about ONFI that is written for health professionals.

For more information about ONFI, go to www.lundbeckus.com or call Lundbeck at 1-888-514-5204.

What are the ingredients in ONFI?

Tablets
Active ingredient: clobazam
Inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, silicon dioxide, and talc.

Oral Suspension
Active ingredient: clobazam
Inactive ingredients: magnesium aluminum silicate, xanthan gum, citric acid monohydrate, disodium hydrogen phosphate dihydrate, simethicone emulsion, polysorbate 80, methylparaben, propylparaben, propylene glycol, sucralose, maltitol solution, berry flavor, purified water.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Marketed by: Lundbeck, Deerfield, IL 60015, U.S.A.

ONFI is a registered trademark of Lundbeck

11/2013


Instructions for Use
ONFI® (ON-fee)
(clobazam)
Oral Suspension

Read this Instructions for Use before using ONFI oral suspension and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or treatment.

Prepare ONFI Oral Suspension Dose
You will need the following supplies: See Figure A

Figure A
onfi-04

Step 1. Remove the ONFI oral suspension bottle, bottle adapter, and 1 syringe from the box.

Step 2. Shake the bottle well before each use. See Figure B

Figure B
onfi-05

Step 3. Uncap the bottle and firmly insert the bottle adapter into the bottle until the adapter top is even with the bottle top. See Figure C

Figure C
onfi-06

Once the bottle adapter is in place, it should not be removed.

Step 4. Check your dose in milliliters (mL) as prescribed by your healthcare provider. Find this number on the syringe. Do not take more than the prescribed total dose in 1 day. See Figure D

Figure D
onfi-07

Step 5. Push the plunger all the way down and then insert the syringe into the upright bottle through the opening in the bottle adapter. See Figure E

Figure E
onfi-08

Step 6. With the syringe in place, turn the bottle upside down. Pull the plunger to the number of mLs needed (the amount of liquid medicine in Step 4). See Figure F

Figure F
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Measure the mLs of medicine using the black ring on the white plunger. See Figure G

Figure G
onfi-10

Step 7. Remove the syringe from the bottle adapter. Slowly squirt ONFI oral suspension directly into the corner of your mouth or your child's mouth until all of the liquid medicine in the syringe is given. See Figure H

Figure H
onfi-11

Step 8. Cap the bottle tightly with the adapter in place. If the cap does not fit securely, check to see if the adapter is fully inserted. See Figure I

Store the bottle upright at 68°F to 77°F (20°C to 25°C).

Figure I
onfi-12

Step 9. Wash the oral syringe after each use.

Marketed by: Lundbeck, Deerfield, IL 60015, U.S.A.

ONFI is a registered trademark of Lundbeck

11/2013

Revised: 12/2013
 
Lundbeck LLC