Azelastine Hydrochloride and Fluticasone Propionate (Page 9 of 9)

Instructions for Use

Azelastine Hydrochloride and Fluticasone
Propionate Nasal Spray
(ay″ ze las′ teen hye″ droe klor′ ide floo tik′ a sone proe′ pee oh nate)

For use in your nose only. Do not spray in your eyes.

Read the Instructions for Use before you start to use azelastine hydrochloride and fluticasone propionate nasal spray 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. Before you use azelastine hydrochloride and fluticasone propionate nasal spray, make sure your healthcare provider shows you the right way to use it.

Shake the bottle gently before each use.

Your azelastine hydrochloride and fluticasone propionate nasal spray pump. (See Figure A)

Figure A

Instructions for Using Your Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray Pump.

Before you use azelastine hydrochloride and fluticasone propionate nasal spray for the first time, you will need to shake the bottle gently and prime the pump.

For use in young children: An adult should help a young child use azelastine hydrochloride and fluticasone propionate nasal spray. (See Steps 1 through 12).

Priming your azelastine hydrochloride and fluticasone propionate nasal spray pump
Before you prime the bottle, shake it gently.

Step 1.

Remove the clear plastic dust cap from the spray pump tip of the bottle. (See Figure B)

Figure B

Step 2.

Hold the bottle upright with two fingers on the shoulders of the spray pump unit and put your thumb on the bottom of the bottle. Press upward with your thumb and release for the pumping action.

•

Repeat the pumping action until you see a fine mist. You should see a fine mist of the medicine after 6 pumps or less. (See Figure C)

•

To get a fine mist of medicine, you must repeat the pumping action fast and use firm pressure against the bottom of the bottle.

•

If you see a stream of liquid, the spray will not work right and may cause nasal discomfort.

•

If you do not use azelastine hydrochloride and fluticasone propionate nasal spray for 14 or more days, you will need to shake the bottle gently, and prime the pump with 1 spray or until you see a fine mist. If you do not see a fine mist, clean the tip of the spray nozzle. See the cleaning section below.

•

Once you see the fine mist of medicine, your azelastine hydrochloride and fluticasone propionate nasal spray pump is ready for use.

Figure C

Using your azelastine hydrochloride and fluticasone propionate nasal spray:

For use in young children: An adult should help a young child use azelastine hydrochloride and fluticasone propionate nasal spray.

Step 3.

Gently blow your nose to clear nostrils. (See Figure D)

Figure D

Step 4.

Shake the bottle gently. Close 1 nostril with a finger. Tilt your head forward slightly. Keep the bottle upright and carefully place the spray pump tip ¼ to ½ inch into your other nostril. (See Figure E)

Figure E

Step 5.

For each spray firmly press the pump 1 time. Keep your head tilted down and at the same time, gently breathe in through your nostril. (See Figure F)

Do not spray directly onto the nasal septum (the wall between your 2 nostrils).

•

Repeat Step 5 in your other nostril.

•

Do not tilt your head back. This will help to keep the medicine from going into your throat.

•

If the medicine goes into your throat you may get a bitter taste in your mouth. This is normal.

Figure F

Step 6.

When you finish using azelastine hydrochloride and fluticasone propionate nasal spray, wipe the spray tip with a clean tissue or cloth. Put the dust cap back on the spray pump tip of the bottle. (See Figure G)

Figure G

Each bottle of azelastine hydrochloride and fluticasone propionate nasal spray contains enough medicine for you to spray medicine from the bottle 120 times. After initial priming, do not use your bottle of azelastine hydrochloride and fluticasone propionate nasal spray after 120 sprays. You may not receive the right amount of medicine. Keep track of the number of sprays you use from your bottle of azelastine hydrochloride and fluticasone propionate nasal spray and throw away the bottle even if it has medicine left in it.

Do not count any sprays used for initially priming the bottle.

Cleaning the Spray Pump Tip:

Your azelastine hydrochloride and fluticasone propionate nasal spray should be cleaned at least 1 time each week. To do this:

Step 7.

Remove the dust cap and then gently pull upward on the spray pump unit to remove it from the bottle. (See Figure H)

Figure H

Step 8.

Wash the spray pump unit and dust cap in warm tap water. (See Figure I)

Figure I

Step 9.

Allow to dry completely. When dry, place the spray pump unit and dust cap back on the bottle. (See Figure J)

Figure J

Step 10.

If the spray pump unit becomes blocked, it can be removed as instructed above in Step 7 and placed in warm water to soak.

Do not try to unblock the spray pump unit by inserting a pin or other sharp object. This will damage the spray pump unit and cause you not to get the right dose of medicine.

Step 11.
After the spray pump unit is unblocked, rinse the applicator and cap with cold water, and allow them to dry as in Step 10 above. When dry, place the spray pump unit back on the bottle and put the dust cap on the spray pump tip.

Step 12.
Reprime the bottle as in Steps 1 and 2 above. Replace the dust cap and your azelastine hydrochloride and fluticasone propionate nasal spray is ready for use.

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

U.S. Patents 8,163,723; 8,168,620; 9,259,428; and 9,901,585

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Manufactured by:
Cipla Ltd. Goa, India
M.L. No. 546

The brands listed are trademarks of their respective owners.

© 2021 Viatris Inc.

Revised: 5/2021
PL:AFNS:R2p
21089209

PRINCIPAL DISPLAY PANEL – 137 mcg/50 mcg

NDC 0378-3458-23

Azelastine
Hydrochloride
and
Fluticasone
Propionate
Nasal Spray
137 mcg / 50 mcg
per spray

120 Metered Sprays

FOR NASAL
USE ONLY

Shake the bottle gently
before each use.

Rx Only 23 g net fill weight

Each spray delivers 0.137 mL
(137 mcg azelastine hydrochloride and
50 mcg fluticasone propionate).

Contents: An aqueous suspension
containing azelastine hydrochloride,
fluticasone propionate, glycerin,
microcrystalline cellulose and
carboxymethylcellulose sodium,
phenylethyl alcohol (2.5 mg/g), edetate
disodium, benzalkonium chloride
(0.1 mg/g), polysorbate 80 and purified
water, pH 6.

Dosage: See enclosed full Prescribing
Information.

Storage:
Store upright, with dust cap in place,
at controlled room temperature
20° to 25°C (68° to 77°F).
Protect from light. Do not store
in the freezer or refrigerator.

Keep away from children.

FOR NASAL USE ONLY

Shake the bottle gently before each
use.

Initial Priming: 6 sprays or until a fine
mist appears.

Repriming (only if you have not used
azelastine hydrochloride and fluticasone
propionate nasal spray for 14 or more days):
1 spray or until a fine mist appears.

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Manufactured by:
Cipla Ltd. Goa, India
M.L. No. 546

CPL:3458:1C:R2

© 2021 Viatris Inc.

U.S. Patents 8,163,723; 8,168,620; 9,259,428;9,901,585

Read PATIENT INSTRUCTIONS FOR USE
for additional information on how
to use the product.

Dosing Instructions

CLEAR YOUR NOSE

Clear your nostrils by gently blowing
your nose.

LOOK AT YOUR TOES

Tilt your head down to keep the
medicine from going into your throat.

SPRAY AND SNIFF GENTLY

Shake the bottle gently before
each use.

Spray a fine mist, once per nostril.
Remember to sniff gently.
Discard after 120 actuations.

For assistance call 1-877-446-3679 (1-877-4-INFO-RX)

AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE azelastine hydrochloride and fluticasone propionate spray, metered

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-3458 Route of Administration NASAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AZELASTINE HYDROCHLORIDE (AZELASTINE) AZELASTINE HYDROCHLORIDE 137 ug FLUTICASONE PROPIONATE (FLUTICASONE) FLUTICASONE PROPIONATE 50 ug

Inactive Ingredients Ingredient Name Strength GLYCERIN MICROCRYSTALLINE CELLULOSE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM PHENYLETHYL ALCOHOL EDETATE DISODIUM BENZALKONIUM CHLORIDE POLYSORBATE 80 WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0378-3458-23 1 BOTTLE in 1 BOX contains a BOTTLE 1 120 SPRAY, METERED in 1 BOTTLE This package is contained within the BOX (0378-3458-23)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA authorized generic NDA202236 04/14/2020

Labeler — Mylan Pharmaceuticals Inc. (059295980)

Revised: 05/2021 Mylan Pharmaceuticals Inc.