Taflotan

Package Leaflet: Information for the Patient

TAFLOTAN, 15 micrograms/ml, eye drops, solution in a single-dose container

Tafluprost

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What is TAFLOTAN and what is it used for
• 2. Important information before using TAFLOTAN
• 3. How to use TAFLOTAN
• 4. Possible side effects
• 5. How to store TAFLOTAN
• 6. Contents of the pack and other information

1. What is TAFLOTAN and what is it used for

What type of medicine is it and how does it work?

TAFLOTAN eye drops contain tafluprost, which belongs to a group of medicines called prostaglandin analogues. TAFLOTAN lowers the pressure in the eye. This medicine is used when the pressure in the eye is too high.

What is it used for?

TAFLOTAN is used to treat a type of glaucoma called open-angle glaucoma and a condition called ocular hypertension in adults. Both of these conditions are related to increased pressure within the eyeball and can lead to vision disturbances.

2. Important information before using TAFLOTAN

When not to use TAFLOTAN

• if you are allergic to tafluprost or any of the other ingredients of this medicine (listed in section 6)

Warnings and precautions

Before starting to use TAFLOTAN, discuss it with your doctor, pharmacist, or nurse.
Considerthat TAFLOTAN may cause the following effects, some of which may be permanent:

• TAFLOTAN may increase the length, thickness, intensity of color, and/or number of eyelashes, and may cause abnormal hair growth on the eyelids.
• TAFLOTAN may cause darkening of the skin around the eyes. Wipe off any solution remaining on the skin after administration to reduce the risk of skin darkening.
• TAFLOTAN may change the color of the iris (the colored part of the eye). If TAFLOTAN is used in only one eye, the color of the treated eye may change permanently and differ from the other eye.
• TAFLOTAN may cause hair growth in areas where the solution comes into repeated contact with the skin.

Tell your doctor

• if you have kidney disease;
• if you have liver disease;
• if you have asthma;
• if you have other eye conditions.

Children and adolescents

TAFLOTAN is not recommended for children and adolescents under 18 years of age due to a lack of data on efficacy and safety.

TAFLOTAN and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.
If you are using other eye medicines, wait at least 5 minutes between administering TAFLOTAN and the other medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or think you may be pregnant, you must use effective contraceptive methods during treatment with TAFLOTAN. Do not use TAFLOTAN if you are pregnant or breastfeeding. Consult your doctor.

Driving and using machines

TAFLOTAN has no influence on the ability to drive and use machines.
For a short time after administration, vision may be blurred. Do not drive or operate machinery until your vision is clear.
After using TAFLOTAN, wait until your vision is clear before driving or operating machinery.

TAFLOTAN contains phosphate buffer

This medicine contains about 0.04 mg of phosphates per drop, which corresponds to 1.2 mg/ml.
In patients with severe damage to the clear front part of the eye (cornea), phosphates may, in very rare cases, cause corneal clouding due to calcium accumulation during treatment.

3. How to use TAFLOTAN

Always use this medicine exactly as your doctor or pharmacist has told you.
If you are not sure, ask your doctor or pharmacist.
The recommended dose of TAFLOTAN is one drop in the eye(s) once daily in the evening. Do not use more drops or use them more often than your doctor has told you, as this may reduce the effect of TAFLOTAN.
Use TAFLOTAN in both eyes only on the advice of your doctor.
TAFLOTAN is for use in the eye only. Do not swallow.

How to use:

When opening a new pouch:
Do not use single-dose containers if the pouch is damaged. Tear the pouch along the perforation. Write the date of opening on the space provided on the pouch.
Each time you use TAFLOTAN:

• 1. Wash your hands.
• 2. Remove the connected single-dose containers from the pouch.
• 3. Separate one single-dose container.
• 4. Put the remaining containers back in the pouch and fold the edge to close the pouch.
• 5. Make sure the solution is in the bottom part of the single-dose container.

• 6. Open the container by twisting the tab at the top of the container.

• 7. Tilt your head back.
• 8. Bring the tip of the container close to your eye.

• 9. Pull the lower eyelid down and look up.
• 10. Gently squeeze the container to release one drop into the space between the lower eyelid and the eye.

• 11. Close your eye and press the inner corner of your eye with your finger for about one minute. This will help prevent the drop from draining into the tear duct.
• 12. Wipe off any excess solution from the skin around your eye.

If the drop does not get into your eye, repeat the administration attempt.
If your doctor has advised you to use drops in both eyes, repeat steps 7 to 12 for the second eye.
The contents of one single-dose container are enough for both eyes.
Discard the opened single-dose container and any remaining solution immediately after use.
If you are using other eye medicines, wait at least 5 minutes between administering TAFLOTAN and the other medicine.
Using more TAFLOTAN than prescribedshould not cause serious harm. Take the next dose at the usual time.
If you accidentally swallow TAFLOTAN, contact your doctor.
Missing a dose of TAFLOTAN. Take one drop in the eye(s) as soon as you remember, and then continue with your regular dosing schedule. Do not take a double dose to make up for a missed dose.

Do not stop using TAFLOTAN without consulting your doctor. Stopping

use of TAFLOTANcan lead to increased eye pressure again, which may cause permanent damage to your eye.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most side effects are not serious.

Common side effects

The following effects may affect up to 1 in 10 people:
Nervous system disorders:

• headache.

Eye disorders:

• eye itching
• eye irritation
• eye pain
• eye redness
• changes in length, thickness, and number of eyelashes
• dry eye
• feeling of something in the eye
• change in eyelash color
• eyelid redness
• spot-like inflammation of the eye surface
• increased sensitivity to light
• excessive tearing
• blurred vision
• reduced ability to see details clearly
• change in iris color (may be permanent).

Uncommon side effects

The following effects may affect up to 1 in 100 people:
Eye disorders:

• change in skin color around the eyes
• eyelid swelling
• eye fatigue
• conjunctival swelling
• eye discharge
• eyelid inflammation
• signs of inflammation inside the eye
• eye discomfort
• conjunctival discoloration
• conjunctival nodules
• allergic inflammation
• changed sensation in the eye.

Skin and subcutaneous tissue disorders:

• abnormal hair growth on the eyelids

Frequency not known: cannot be estimated from the available data

Eye disorders:

• inflammation of the iris/ciliary body (the middle layer of the eye)
• sunken eye appearance
• macular edema (swelling of the retina leading to vision impairment).

Respiratory, thoracic, and mediastinal disorders:

• worsening of asthma, shortness of breath

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Pharmacovigilance Department, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TAFLOTAN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the single-dose container, pouch, and outer carton after EXP. The expiry date refers to the last day of that month.
Unopened foil pouches should be stored in the refrigerator (2°C – 8°C). Open the pouch just before using the eye drops, as unused containers from an opened pouch must be discarded after 28 days.
After opening the foil pouch:

• Store the single-dose containers in the original foil pouch;
• Store below 25°C;
• Discard unused single-dose containers after 28 days from first opening the pouch;
• Discard the opened single-dose container and any remaining solution immediately after use.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What TAFLOTAN contains

• -The active substance is tafluprost. 1 ml of solution contains 15 micrograms of tafluprost. One single-dose container (0.3 ml) contains 4.5 micrograms of tafluprost. One drop (about 30 µl) contains about 0.45 micrograms of tafluprost.
• -The other ingredients are glycerol, sodium dihydrogen phosphate dihydrate, disodium edetate, polysorbate 80, and water for injections. Small amounts of hydrochloric acid or sodium hydroxide may be added to maintain the appropriate pH.

What TAFLOTAN looks like and contents of the pack

TAFLOTAN is a clear, colorless solution (liquid) in plastic single-dose containers containing 0.3 ml of solution. One pouch contains ten single-dose containers. TAFLOTAN is available in packs containing 30 or 90 single-dose containers. Not all pack sizes may be marketed.

Marketing Authorization Holder

Santen Oy
Niittyhaankatu 20
33720 Tampere
FINLAND

Manufacturer

Santen Oy
Kelloportinkatu 1
33100 Tampere
FINLAND

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Bulgaria, Czech Republic, Denmark, Finland, Estonia, Hungary, Iceland, Lithuania, Latvia, Norway, Poland, Slovakia, Sweden: TAFLOTAN
Austria, Belgium, Cyprus, France, Greece, Spain, Netherlands, Ireland, Luxembourg, Malta, Portugal, Romania, Slovenia, Italy, United Kingdom (Northern Ireland): SAFLUTAN
Germany: TAFLOTAN sine
Date of last revision of the leaflet:07/2021
Detailed information on this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.