Uceris (Page 5 of 6)

Instructions for Use

UCERIS® (u SAIR us)

(budesonide)

rectal foam

Read the Patient Information and Instructions for Use that comes with UCERIS® rectal foam before you start using it. Talk to your healthcare provider if you have any questions.

Before using UCERIS rectal foam, you should use the bathroom to empty your bowels.

You may use UCERIS rectal foam while in a standing position, in a lying position, or in a sitting position (for example, while using the toilet).

Applicators should be used only 1 time. You should use a new applicator for each dose.

FigureA
(click image for full-size original)

Each kit contains (See Figure A):

Complete Prescribing Information
Patient Information and Instructions for Use
2 canisters containing 14 doses each
4 trays of single-use applicators (7 applicators per tray)
Applicator disposal bags for use after each dose

Preparing to use UCERIS rectal foam

ifu3
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Step 1: Twist Safety Tab to Remove

Before the first use, remove the safety tab from under the pump dome (See Figure B).

ifu19The canister cannot be used if safety tab is not removed.

Figure B

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Step 2: Attach the Applicator

The applicators are in a special tray. Hold the tray firmly and pull to remove 1 applicator.

Push the applicator firmly onto the nozzle of the canister (See Figure C).

Each applicator is coated with a lubricant. If needed, you can apply an additional lubricant, such as Vaseline® (petrolatum, petroleum jelly).

Figure C

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Step 3: Align Notch to Nozzle

To unlock the canister, twist the dome on the top of the canister until the semicircular notch underneath the dome is in line with the nozzle (See Figure D).

Figure D

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Step 4: Warm and Shake Canister

Warm the canister by holding it in your hands while shaking it vigorously for 10 to 15 seconds (See Figure E).

Figure E

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Step 5: Turn the Canister Upside Down

Place your forefinger on the top of pump dome and then turn the canister upside down (See Figure F).

ifu19The canister will only work properly when held with the pump dome pointing down.

Figure F

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Step 6: Insert the Applicator into Rectum

Insert the applicator into your rectum as far as it is comfortable.

The easiest way to use UCERIS rectal foam is to keep one foot on the floor and raise the other foot onto a firm surface such as a chair or stool (See Figure G).

Figure G

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Step 7: Give a Dose of UCERIS Rectal Foam

To give a dose of UCERIS rectal foam, use your forefinger to fully push down the pump dome one time and hold it for about 2 seconds in that position (See Figure H).

Figure H

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Step 8: Release and Hold

Release finger pressure on the pump dome and hold the applicator in place for 10 to 15 seconds (See Figure I).

Figure I

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Step 9: Remove the Applicator

(See Figure J)

The foam will still expand a little and may drop out of the applicator or anus.

Figure J

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Step 10: Remove Applicator from Canister

Remove the applicator from the canister and place the used applicator in the plastic bag provided. (See Figure K). Throw the plastic bag away in your household trash.

Figure K

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Step 11: Twist Notch on Dome Away from Nozzle

To prevent loss of UCERIS rectal foam from the canister between uses, turn the pump dome around so that the semicircular notch faces the opposite direction to the nozzle (See Figure L).

ifu19Wash your hands with soap and water. Try not to empty your bowels until the next morning.

Figure L

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

Manufactured by:
Salix Pharmaceuticals, a division of Valeant Pharmaceuticals North America
LLC, Bridgewater, NJ 08807 USA
Product marketed and distributed under license from Dr. Falk Pharma.

Uceris is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.

© Valeant Pharmaceuticals North America LLC

9499001

7001205

Revised: 09/2016

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