Patanase® Nasal Spray (olopatadine HCI) 665 mcg

Alcon

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PATANASE^® Nasal Spray The fast-acting allergy symptom reducer

PATANASE^® Nasal Spray is a steroid-free prescription nasal spray that works quickly to fight the symptoms of seasonal allergic rhinitis, commonly known as hay fever, in patients 6 years of age and older.

PATANASE^® Nasal Spray is:

• Fast acting
• Long lasting
• Steroid-free

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

PATIENT INFORMATION

PATANASE^® (PAT-uh-nase) (olopatadine hydrochloride) Nasal Spray

For Use in the nose (Intranasal) only.

Read the Patient Information that comes with PATANASE^® Nasal Spray carefully before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your health care provider about your medical condition or your treatment.

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 of age 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, edetate 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.

Mfd for:
Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA

Mfd by:
Alcon Cusi, S.A.
08320 El Masnou-Barcelona
© 2008, Alcon, Inc.

Olopatadine is licensed from KYOWA HAKKO KOGYO CO., LTD. Japan. PATANASE^® Nasal Spray (olopatadine hyrochloride nasal spray) is a registered mark of Alcon, Inc. PATANASE^® Nasal Spray is available by prescription only.

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