Varenicline (var-EN-i-kleen)

Treats symptoms of dry eye disease.

Brand Name(s):

Tyrvaya

When This Medicine Should Not Be Used:

How to Use This Medicine:

Spray

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• This medicine is for use only in the nose. Do not get any of it in your eyes or on your skin. If it does get on these areas, rinse it off right away.
• You will need to prime the nasal spray before you use it for the first time. To do this, pump the bottle 7 times into the air away from the face. Prime the spray if you have not used it for more than 5 days, by spraying the medicine 1 time into the air. Do not prime it for more than needed.
• Before using the medicine, gently blow your nose to clear the nostrils.
• After using the nasal spray, wipe the tip of the bottle with a clean tissue and put the cap back on.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Skip the missed dose and go back to your regular dosing schedule. Do not double doses.
• Keep the bottle tightly closed when not using it. Store at room temperature, away from heat and direct light. Do not shake or freeze the bottle. Throw this medicine away 30 days after opening the bottle.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing

If you notice these less serious side effects, talk with your doctor:

• Burning, redness, or swelling around or inside your nose
• Cough, sneezing, sore throat

If you notice other side effects that you think are caused by this medicine, tell your doctor

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