Acoltremon Ophthalmic

WHY is this medicine prescribed?

Acoltremon ophthalmic solution is used to treat signs and symptoms of dry eye disease (a condition where tears aren't able to provide adequate moisture for your eyes). Acoltremon is in a class of medications called transient receptor potential melastatin 8 (TRPM8) agonists. It works by increasing tear production.

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?

Ophthalmic acoltremon comes as a solution (liquid) to instill in the eyes. Instill in each eye twice a day, about 12 hours apart. Instill acoltremon eye drops at around the same times every day.

Use acoltremon eye drops exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Remove contact lenses before using the eye drops and keep them out for 15 minutes after using the eye drops.

Acoltremon eye drops come in single-use containers (small bottles to be used for one dose). Use the liquid from the container immediately after opening for both eyes. Throw away the container with any remaining liquid in it when you are finished. Do not save the liquid left in the container for your next dose.

To use the eye drops, follow these steps:

1. Wash your hands thoroughly with soap and water.
2. Take the strip of single-use containers from the foil pouch. Pull off one single-use container from the strip. Put the remaining strip of single-use containers back in the foil pouch.
3. Hold the container upright. Be sure the twist off tab is at the top of the container.
4. Open the container by twisting off the tab at the top of the container.
5. Tilt your head backwards. If you are not able to tilt your head, lie down.
6. Place the tip of the single-use container close to your eye. Be careful not to touch your eye with the tip of the container.
7. Pull your lower eyelid downwards and look up.
8. Gently squeeze the container and let a single drop fall into the space between your lower eyelid and your eye. If the drop misses your eye, try again.
9. Close your eye for a few seconds. Try not to blink or squeeze your eyelids.
10. Dispose of the single-use container out of the reach of children even if it is not empty.

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

What SPECIAL PRECAUTIONS should I follow?

Before using acoltremon eye drops,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.

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

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using acoltremon eye drops, call your doctor.

• If you are using another topical eye medication, use it at least 5 minutes before or after you instill acoltremon eye drops.

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?

Acoltremon eye drops may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• irritation, burning, or stinging feeling when the eye drops are instilled

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• pain, swelling, or redness of eyes or eyelids
• eye injury

Acoltremon eye drops may cause other side effects. Call your doctor if you have any unusual problems while taking 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 (https://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 foil pouch it came in, tightly closed, and out of reach of children. Store unopened cartons containing foil pouches in the refrigerator. Once opened, the carton can be kept in the refrigerator until the expiration date printed on the package has passed, or stored at room temperature for up to 30 days. Protect the medication from light, excess heat and moisture (not in the bathroom). When you remove a foil pouch from the carton, write down the date you opened it in the space provided on the pouch. Store opened foil pouches containing single-use containers of acoltremon solution for up to 7 days.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

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?

Keep all appointments with your doctor.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.