FORMULATED WITH NCELL Technology
WHAT IS CEQUA?
CEQUATM (cyclosporine ophthalmic solution) 0.09% is a topical solution that helps to increase the production of natural tears in your eye. Dry eye disease may affect the ability of your eyes to produce its own tears.
IMPORTANT SAFETY INFORMATION
Do not use CEQUA if you are allergic to any of its ingredients. Be careful not to allow the vial tip to touch your eye or any surfaces, to help avoid potential eye injury or contamination of the product.
CEQUA should not be used while wearing contact lenses. If contact lenses are worn, they should be
removed prior to using CEQUA and may be reinserted after 15 minutes.
Put one drop of CEQUA twice daily (approximately 12 hours apart) into each eye using a single-use vial. The solution should be used immediately after opening, and discard the vial and remaining contents immediately after using.
The most common side effects that may be experienced while using CEQUA include: eye pain after administering drops and eye redness. Other side effects reported were eye irritation, eyelid inflammation, headache, and urinary tract infection.
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. Please see the Brief Summary on the following page.
© 2020 Sun Ophthalmics, a division of Sun Pharmaceutical Industries, Inc. All rights reserved.
CEQUA and NCELL are trademarks of Sun Pharma Global FZE. PM-US-CQA-0622 12/2020
Brief Summary: Read this information before you start using CEQUA™ (cyclosporine ophthalmic solution) 0.09% and each time you get a refill of your prescription. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment.
What is CEQUA?
CEQUA 0.09% is a prescription eye drop solution that helps to increase the production of natural tears in your eye. Dry eye disease may affect the ability of your eyes to produce its own tears. It is not known if CEQUA is safe and effective in children under the age of 18.
When should I not use CEQUA?
Do not use CEQUA if you are allergic to any of its ingredients.
What should I tell my doctor before using CEQUA?
Before you use CEQUA, tell your doctor if you:
• are using any other eye drops
• wear contact lenses
• are pregnant or plan to become pregnant. It is not known if CEQUA will harm your unborn baby
• are breastfeeding or plan to breastfeed. It is not known if CEQUA passes into breast milk. Talk to your doctor about the best way to feed your baby if you use CEQUA
How should I use CEQUA?
Talk to your doctor or pharmacist for additional instructions about the right way to use CEQUA.
Use CEQUA exactly as your doctor or pharmacist tells you.
• Be careful not to allow the vial tip to touch your eye or any surfaces. This will help avoid potential eye injury or contamination of the product
• CEQUA should not be used while wearing contact lenses. If you wear contact lenses, remove them before using CEQUA and wait for at least 15 minutes before placing them back in your eyes
• Put 1 drop of CEQUA 2 times a day (about 12 hours apart) into each eye using a vial for each dose. The solution should be used immediately after opening. After use, throw away remaining medication in the vial
What are the possible side effects of CEQUA?
The most common side effects that may be experienced while using CEQUA include eye pain after administering drops and eye redness.
Other side effects that have been reported were eye irritation, eyelid inflammation, headache, and urinary tract infection.
These are not all the possible side effects of CEQUA. Tell your doctor if you have any other side effects that bother you. You may report side effects to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.
How should I store CEQUA?
Store CEQUA at room temperature of 20°C to 25°C (68°F to 77°F).
General information about the safe and effective use of CEQUA
Ask your doctor or pharmacist for information about CEQUA that is written for healthcare professionals. Do not use CEQUA for a condition for which it was not prescribed. Do not give CEQUA to other people, even if they have the same symptoms you have. It may harm them.
What are the ingredients in CEQUA?
Active: cyclosporine 0.09%
Inactives: Polyoxyl 40 Hydrogenated Castor Oil, Octoxynol-40, polyvinylpyrrolidone, sodium phosphate monobasic dihydrate, sodium phosphate dibasic anhydrous, sodium chloride, water for injection, and sodium hydroxide or hydrochloric acid to adjust pH.
The information provided here is not comprehensive. To learn more, talk about CEQUA with your doctor or pharmacist.
Manufactured by: Sun Pharma Global FZE
By: Laboratoire Unither Coutances, France
Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512
© 2020 Sun Ophthalmics, a division of Sun Pharmaceutical Industries, Inc. All rights reserved.
CEQUA is a trademark of Sun Pharma Global FZE.
RX ONLY