ONFI- clobazam tablet 
ONFI- clobazam suspension 
Lundbeck Pharmaceuticals LLC

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

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

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.

Do not take ONFI if you:

Before you take ONFI, tell your healthcare provider about all your medical conditions, including if you:

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

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. 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

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. You can ask your pharmacist or healthcare provider for information about ONFI that is written for health professionals.

What are the ingredients in ONFI?

Tablets
Active ingredient: clobazam
Inactive ingredients: modified 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.

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

ONFI is a registered trademark of Lundbeck

For more information about ONFI, go to www.ONFI.com or call Lundbeck at 1-866-402-8520

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This Medication Guide has been approved by the U.S. Food and Drug Administration                                                                                                                           Revised: 12/2016


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
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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
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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
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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
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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
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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
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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
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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

Figure I
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Step 9. Wash the oral syringe after each use.

This Instruction for Use has been approved by the U.S. Food and Drug Administration. 

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

logo

ONFI is a registered trademark of Lundbeck

12/2016

Revised: 2/2017
Lundbeck Pharmaceuticals LLC