Patient information: uses, side effects, how to take - Patanase

What is PATANASE Nasal Spray?

PATANASE Nasal Spray is a prescription medicine used to provide relief of seasonal allergy symptoms in adults and children 6 years and older.

PATANASE Nasal Spray contains an antihistamine medicine that may help reduce nasal symptoms of seasonal allergic rhinitis.

What should I tell my health care provider before taking PATANASE Nasal Spray?

Tell your health care provider about all your medical conditions, including if you are:

allergic to any of the ingredients in PATANASE Nasal Spray. See the end of this leaflet for a complete list of the ingredients in PATANASE Nasal Spray.
pregnant or planning to become pregnant. It is not known if PATANASE Nasal Spray will harm your unborn baby.
breast-feeding a baby. It is not known if PATANASE Nasal Spray passes into your breast milk.

Tell your health care provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal products. PATANASE Nasal Spray and other medicines may affect each other, causing side effects.

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

How should I use PATANASE Nasal Spray?

PATANASE Nasal Spray is for use in the nose only. Do not spray it in your eyes or mouth.
Use PATANASE Nasal Spray exactly as your health care provider tells you. Do not stop taking PATANASE Nasal Spray without talking to your health care provider.
This nasal device should be discarded after the labeled number of sprays (240) or after

the expiration date on the medicine label or box.

Do not use PATANASE Nasal Spray after the expiration date on the medicine label and box.

Follow the Patient Instructions for Use below.

What are the possible side effects of PATANASE Nasal Spray?

Side effects of PATANASE Nasal Spray include:

bad or bitter taste
headache
nosebleeds
sores in your nose
hole in the nasal septum

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

These are not all of the possible side effects of PATANASE Nasal Spray. For more information, ask your health care provider or pharmacist.

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

What should I avoid while using PATANASE Nasal Spray?

PATANASE Nasal Spray can make you sleepy.

Avoid the following while using PATANASE Nasal Spray:

operating machinery, driving a motor vehicle, or doing other dangerous activities
using alcohol or other medicines that can also make you sleepy, such as sedatives and tranquilizers

General information about PATANASE Nasal Spray

Medicines are sometimes prescribed for conditions that are not mentioned in the patient leaflet. Do not use PATANASE Nasal Spray for a condition for which it was not prescribed. Do not give PATANASE Nasal Spray to other people, even if they have the same symptoms you have. It may harm them.

This patient information leaflet summarizes the most important information about PATANASE Nasal Spray. If you would like more information about PATANASE Nasal Spray talk with your health care provider. You can ask your health care provider or pharmacist for information about PATANASE Nasal Spray that is written for health professionals. For more information go to www.PATANASE.com or call 1-800-757-9195.

What are the ingredients of PATANASE Nasal Spray?

Active ingredient: olopatadine hydrochloride 665 micrograms per 100 microliter spray.

Inactive ingredients: 0.01% benzalkonium chloride, sodium phosphate, dibasic, edentate disodium, sodium chloride, hydrochloric acid, sodium hydroxide and water.

What should I know about seasonal allergic rhinitis?

"Rhinitis" means inflammation of the lining of the nose. Seasonal allergic rhinitis is sometimes called "hay fever". Seasonal allergic rhinitis can be caused by allergies to pollen. If you have allergic rhinitis, your nose becomes stuffy, runny and itchy. You may also sneeze a lot. You may also have red, itchy, watery eyes and itchy throat, or blocked itchy ears.

PHARMACIST Give to Patient

Patient Instructions for Use

Rx Only

For use in the nose (Intranasal) only

Use PATANASE® Nasal Spray exactly how your doctor tells you to. The usual dose of PATANASE Nasal Spray for people ages 12 and older is two sprays in each nostril, two times each day and for children 6 to 11, one spray in each nostril two times a day.

1. Remove the blue plastic overcap (Figure 1).
2. Hold the bottle and press down on the shoulders of the white nasal applicator with your forefinger and middle finger.

Support the bottom (base) of the bottle with your thumb while you do this (Figure 2). Prime the bottle five (5) times or until you see a fine mist come out of the nasal spray applicator. After you start using a bottle of PATANASE Nasal Spray, if you do not use it for more than seven (7) days, you will need to prime the pump again two (2) times before use.

3. Gently blow your nose to clear the nostrils. Close one nostril. With your head tipped down (chin toward chest), place the nasal applicator 1/4 to 1/2 inch into a nostril. Hold the medicine bottle upright with the nasal applicator tip aimed toward the cheek side of the nose, away from the center of the nose (Figure 3).
4. Breathe in gently through your nose. While breathing in press firmly and quickly on the applicator to release the spray (Figure 3).
5. Breathe out through your mouth. Do not tip your head back or blow your nose right after using PATANASE Nasal Spray. This may cause you to get a bitter taste in your mouth.
6. Change between the nostrils (alternate). Spray two sprays in each nostril.

7. Wipe the nasal applicator with a clean tissue and replace the blue plastic overcap. (Figure 4)
8. This nasal device should be discarded after the labeled number of sprays (240) or after the expiration date on the medicine label or box.
9. Do not take extra doses or stop taking PATANASE Nasal Spray without talking with your doctor.

1. If the nasal applicator becomes clogged, do not attempt to clear it using a pointed object. (Figure 5)
2. To clean the nasal applicator, remove the plastic cap and then gently pull upwards to free the nasal applicator. (Figure 6 & 7)

3. With the nasal applicator pointing downwards, wash by running warm tap water into the nasal applicator for about one minute. (Figure 8)
4. Shake the applicator to remove any water and put the applicator back on the bottle.
5. Prime by spraying two (2) times or until you see a fine mist.
6. Repeat the above steps if needed.

Store PATANASE Nasal Spray between 39° to 77°F (4° to 25°C).
Do not use your PATANASE Nasal Spray after the expiration date on the label or box.

Keep PATANASE Nasal Spray and all medicines out of the reach of children.

For more information about PATANASE Nasal Spray visit www.PATANASE.com or call 1-800-757-9195.

Mfd. for:

ALCON LABORATORIES, INC.

Fort Worth, Texas 76134 USA

Mfd. by:

ALCON CUSI, S.A.

08320 El Masnou - Barcelona

Spain

Revised: December 2009

6-15-323

Patanase: Uses, Side Effects and Dosage