Tafluprost Ophthalmic

WHY is this medicine prescribed?

Tafluprost ophthalmic is used to treat glaucoma (a condition in which increased pressure in the eye can lead to gradual loss of vision) and ocular hypertension (a condition which causes increased pressure in the eye). Tafluprost is in a class of medications called prostaglandin analogs. It lowers pressure in the eye by increasing the flow of natural eye fluids out of the eye.

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?

Tafluprost comes as a solution (liquid) to instill in the eye. It is usually instilled in the affected eye(s) once a day in the evening. Use tafluprost at around the same time in the evening every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use tafluprost exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Tafluprost ophthalmic comes in single-use containers. The solution from one container should be used immediately after opening for one or both eyes. Dispose of each single-use container and any remaining solution after one use.

Tafluprost controls glaucoma and ocular hypertension but does not cure them. Continue to use tafluprost even if you feel well. Do not stop using tafluprost without talking to your doctor.

Tafluprost ophthalmic is for use only in the eye(s). Do not swallow tafluprost solution.

To instill 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.
3. Pull off one single-use container from the strip.
4. Put the remaining strip of single-use containers back in the foil pouch and fold the edge to close the pouch.
5. Hold the single-use container upright. Make sure that the tafluprost solution is in the bottom part of the single-use container.
6. Open the single-use container by twisting off the tab.
7. Tilt your head backwards. If you are not able to tilt your head, lie down.
8. 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.
9. Pull your lower eyelid downwards and look up.
10. 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.
11. 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 tafluprost,

• tell your doctor and pharmacist if you are allergic to tafluprost, any other medications, or any of the ingredients in tafluprost solution. Ask your pharmacist or check the manufacturer's patient information for a list of the ingredients.

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

• If tafluprost is used with other topical eye medications, allow at least 5 minutes between each medication.

• tell your doctor if you have ever had eye surgery, inflammation of the eye or other eye conditions, and if you have or have ever had any other medical problems.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you are able to become pregnant, you should use an effective form of birth control while you are using tafluprost. If you become pregnant while using tafluprost, call your doctor.

• Tafluprost may change your eye color to brown or a deeper shade of brown. This color change usually occurs slowly, but it may be permanent. If you use tafluprost in only one eye, you should know that there may be a difference in color between your eyes after using tafluprost. Tafluprost also may cause darkening of the color of the skin around your eyes, an increase in the length, thickness, color, or number of your eyelashes, or fine hair on your eyelids. The eyelash changes and any darkening of the skin around your eyes usually go away when you stop using tafluprost.

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?

Instill the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not instill a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

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

• stinging, irritation, or itching of the eye
• dry eyes
• blurry or cloudy vision
• headache

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
• sudden changes or loss of vision
• eye injury
• eye infection

Tafluprost 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 (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 unopened foil pouches containing tafluprost solution in the refrigerator. When you open the foil pouch, write down the date you opened it in the space provided on the pouch. Store opened foil pouches containing single-use containers of tafluprost solution at room temperature and away from excess heat and moisture (not in the bathroom). Dispose of any unused single-use containers left in the foil pouch more than 28 days after it was first opened. Do not use tafluprost if the foil pouch is not sealed when you first receive it.

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.

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

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.

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.