Patient information: uses, side effects, how to take - Tafluprost

What is tafluprost ophthalmic solution?

Tafluprost ophthalmic solution is a prescription eye drop solution used to lower the pressure in the eye (intraocular pressure) in people with open-angle glaucoma or ocular hypertension when their eye pressure is too high. Tafluprost ophthalmic solution belongs to a group of medicines called prostaglandin analogs.

Tafluprost ophthalmic solution is not recommended for use in children.

Before using tafluprost ophthalmic solution, tell your healthcare provider about all of your medical conditions, including if you:

have or have had eye problems including any surgery on your eye or eyes.
are using any other eye medicines.
are pregnant or plan to become pregnant. It is not known if tafluprost ophthalmic solution will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if tafluprost ophthalmic solution passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use tafluprost ophthalmic solution.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show your healthcare provider and

pharmacist when you get a new medicine.

How should I use tafluprost ophthalmic solution?

Read the Instructions for Use at the end of this Patient Information leaflet for additional instructions about the right way to use tafluprost ophthalmic solution.

Use 1 drop of tafluprost ophthalmic solution in your affected eye or eyes each evening. Talk to your healthcare provider or pharmacist if you are not sure how to use tafluprost ophthalmic solution.
Your tafluprost ophthalmic solution may not work as well if you use it more than 1 time each evening.
If you use other medicines in your eye, wait at least 5 minutes between using tafluprost ophthalmic solution and your other eye medicines.
Contact lenses should be taken out before using tafluprost ophthalmic solution and you should wait at least 15 minutes after giving the dose of tafluprost ophthalmic solution before putting the contact lenses back into your eyes.
Use your tafluprost ophthalmic solution right away after opening for use in 1 or both eyes. Each tafluprost ophthalmic solution single-dose container is sterile and is to be used 1 time then thrown away. Do not save any tafluprost ophthalmic solution that may be left over after you use your medicine. Using tafluprost ophthalmic solution that is not sterile may cause other eye problems.

What are the possible side effects of tafluprost ophthalmic solution?

Tafluprost ophthalmic solution may cause serious side effects including:

changes in the color of your eye (iris). Your iris may become more brown in color while using tafluprost ophthalmic solution. This color change may not go away when you stop using tafluprost ophthalmic solution. If tafluprost ophthalmic solution is used in 1 eye only, the color of that eye may always be a different color from the color of your other eye.
darkening of the color of the skin around your eye (eyelid). These skin changes usually go away when you stop using tafluprost ophthalmic solution.
increasing the length, thickness, color, shape and number of your eyelashes. These eyelash changes usually go away when you stop using tafluprost ophthalmic solution.
hair growth on your eyelids. This hair growth usually goes away when you stop using tafluprost ophthalmic solution.
inner eye swelling (inflammation). Swelling or thickening may occur in the center of your eye (macular edema) and swelling in the middle layer of your eye (uveitis, intraocular inflammation) while using tafluprost ophthalmic solution. Tell your healthcare provider if you experience eye inflammation or have a known risk of macular edema.

The most common side effects of tafluprost ophthalmic solution include:

redness, stinging or itching of your eye (conjunctival hyperemia or allergic conjunctivitis)
cataract formation
dry eye
eye pain
blurred vision
headache
common cold
cough
urinary tract infection

Tell your healthcare provider right away if you have any new eye problems while using tafluprost ophthalmic solution including:

an eye injury
an eye infection
a sudden loss of vision
eye surgery
swelling and redness of and around your eye (conjunctivitis)
problems with your eyelids

Tell your healthcare provider if you have any other side effects that bother you.

These are not all the possible side effects of tafluprost ophthalmic solution. For more information, ask your healthcare provider or pharmacist.

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

How should I store tafluprost ophthalmic solution?

Important information for Mail-Order Patients:

Do not use tafluprost ophthalmic solution if the prescription is not received within 2 days of the pharmacy filling (dispensing) date located on the prescription label.

Keep the foil pouches and tafluprost ophthalmic solution single-dose containers dry.

Before opening the foil pouches:

Store the unopened foil pouches in a refrigerator between 36°F to 46°F (2°C to 8°C).
Do not open the pouch containing tafluprost ophthalmic solution until you are ready to use the eye drops.

After opening the foil pouch:

Write down the date of first opening the foil pouch in the space provided on the pouch.
Store the opened foil pouch at room temperature, between 68°F to 77°F (20°C to 25°C), for up to 30 days.
Throw away all unused tafluprost ophthalmic solution single-dose containers in the opened foil pouch after 30 days.
Keep the tafluprost ophthalmic solution single-dose containers in their original foil pouch.
After opening the foil pouch, refrigeration is not required.

Keep tafluprost ophthalmic solution and all medicines out of the reach of children.

General information about the safe and effective use of tafluprost ophthalmic solution.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use tafluprost ophthalmic solution for a condition for which it was not prescribed. Do not give tafluprost ophthalmic solution to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information leaflet summarizes the most important information about tafluprost ophthalmic solution.

If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about tafluprost ophthalmic solution that is written for health professionals.

What are the ingredients in tafluprost ophthalmic solution?

Active ingredients: tafluprost

Inactive ingredients: glycerol, sodium dihydrogen phosphate dihydrate, disodium edetate, polysorbate 80, hydrochloric acid and/or sodium hydroxide, and water for injection.

INSTRUCTIONS FOR USE

Tafluprost (ta’ floo prost)

Ophthalmic Solution 0.0015%

for topical ophthalmic use

Read these Instructions for Use before using your tafluprost ophthalmic solution and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or your treatment.

Important Information You Need to Know Before Using tafluprost ophthalmic solution:

Tafluprost ophthalmic solution is for the eye. Do not swallow tafluprost ophthalmic solution.
Tafluprost ophthalmic solution single-dose containers are packaged in a foil pouch.
Do not use the tafluprost ophthalmic solution single-dose containers if the foil pouch is already opened when you receive it.
Write down the date you open the foil pouch in the space provided on the pouch.
Use 1 drop of tafluprost ophthalmic solution in your affected eye or eyes each evening.
If you use other eye medicines dropped into the eye (topically applied ophthalmic medicines), use each medicine at least 5 minutes apart from each other.

Follow these instructions every time you use tafluprost ophthalmic solution:

Step 1.	Wash your hands and sit or stand comfortably.
Step 2.	Open the foil pouch containing a strip of 5 single-dose containers. Write down the date of first opening on the foil pouch.
Step 3.	Take the strip of single-dose containers from the foil pouch. Break off 1 single-dose container from the strip. Put the remaining strip of unopened single-dose containers back in the foil pouch and fold the edge to close the pouch.
Step 4.	Hold the single-dose container upright. Make sure that your tafluprost ophthalmic solution medicine is in the bottom part of the single-dose container. See Figure A.	Figure A
Step 5.	Twist open the top of the single-dose container as shown. Do not touch the tip after opening the container. See Figure B.	Figure B
Step 6.	Tilt your head backwards. If you are unable to tilt your head, lie down.
Step 7.	Use your finger to gently pull down the lower eyelid of your affected eye and look up. Place the tip of the single-dose container close to your eye, but not touching your eye.
Step 8.	Gently squeeze the single-dose container and let 1 drop of tafluprost ophthalmic solution fall into the space between your lower eyelid and your eye, then release the lower eyelid. If a drop misses your eye, try again. See Figure C.	Figure C

If your healthcare provider has told you to use tafluprost ophthalmic solution drops in both eyes, repeat Steps 6 through 8 for your other eye.
There is enough tafluprost ophthalmic solution in 1 single-dose container for both of your eyes.
Throw away the opened single-dose container with any remaining tafluprost ophthalmic solution right away. Do not keep it to use it again even if there is product left in the container. To lessen the chance of infection, a new single-dose container must be opened each time you are ready to use tafluprost ophthalmic solution.
Place the folded foil pouch back in the carton. The unopened single-dose containers must be used within 30 days after opening the foil pouch. Protect from moisture.

This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration. Revised 08/2026

Manufactured by The Ritedose Corporation, Columbia, SC 29203 for

Sandoz Inc. Princeton, NJ 08540

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