Tyrvaya 0.03 mg Nasal Spray 2X4.2 ml Bottles

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

VARENICLINE - NASAL

(var-EN-i-kleen)

COMMON BRAND NAME(S): Tyrvaya

USES: Varenicline is used to treat dry eyes. It works by increasing the amount of tears you make.

HOW TO USE: Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using varenicline and each time you get a refill. Follow the illustrated directions for the proper use of this medication. If you have any questions, ask your doctor or pharmacist. Follow the instructions to properly prime the bottle if you are using it for the first time or if you have not used it for more than 5 days. Do not shake the bottle. Before using, blow your nose to clear your nostrils. Spray this medication in the nose as directed by your doctor, usually one spray in each nostril, 2 times a day about 12 hours apart. To use the spray, remove the protective cap and clip. Tilt your head back slightly, and keeping the bottle upright, carefully insert the nasal applicator into the nostril. Do not spray directly onto the middle wall of your nose (nasal septum). Breathe in gently while pressing down firmly on the pump to deliver one spray. Repeat in the other nostril. Wipe the applicator tip and replace the plastic cap and clip. Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. Tell your doctor if your condition lasts or gets worse.

SIDE EFFECTS: Sneezing, coughing, or throat/nose irritation may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using varenicline, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor\'s approval.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.

MISSED DOSE: If you miss a dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Do not freeze. Throw away any unused medication 30 days after first opening the bottle. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised November 2021. Copyright(c) 2022 First Databank, Inc.