Varenicline Nasal Spray

WHY is this medicine prescribed?

Varenicline nasal spray is used to treat the signs and symptoms of dry eye disease (an eye disorder in which tears do not provide sufficient eye lubrication). Varenicline is in a class of medications called cholinergic agonists. It works by activating nerve endings in your nose resulting in increased production of tears in the eyes.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Varenicline comes as a liquid to spray in the nose. Varenicline usually is sprayed in each nostril twice daily, about 12 hours apart. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use varenicline exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Do not shake the bottle that contains varenicline nasal spray.

To use the nasal spray, follow these steps:

1. Remove the blue plastic cap and safety clip from the nasal spray pump.
2. If you are using the nasal spray pump for the first time, you must prime the pump. Hold the bottle upright with the applicator between your forefinger and middle finger and your thumb under the bottle. Point the bottle upright and away from your face. Press your thumb and fingers firmly and quickly against the pump 7 times. If you have not used the nasal spray for more than 5 days, reprime the pump with 1 spray.
3. Blow your nose to clear your nostrils if necessary.
4. Tilt your head slightly backwards and carefully put the nasal applicator tip into your nostril. Tilt and point the tip towards the top of the ear on the same side as the nostril. Be careful not let the applicator tip touch the inside of your nose.
5. Place your tongue on the roof of your mouth and breath in gently through your nose. At the same time, press firmly and quickly down on the pump to release a spray.
6. Repeat steps 4 and 5 in the other nostril.
7. Wipe the applicator with a clean tissue and replace the blue plastic cap and safety clip on the bottle.
8. Each bottle has enough medication for 15 days of treatment.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before using varenicline nasal spray,

• tell your doctor and pharmacist if you are allergic to varenicline, any other medications, or any of the ingredients in varenicline nasal spray. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using varenicline nasal spray, call your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Varenicline nasal spray may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• cough
• sneezing
• throat irritation
• nasal irritation

Varenicline nasal spray may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not freeze. Discard the bottle 30 days after opening.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

A 1-month supply of varenicline nasal spray will include 2 nasal spray bottles. Finish using the first bottle before opening the second bottle.

Keep all appointments with your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.