Patient Information Leaflet

SAFLUTAN 15 micrograms/mL

Single-dose eye drop solution

Tafluprost

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

6. Contents of the pack and additional information

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

SAFLUTAN eye drops contain tafluprost, which belongs to a group of medications called prostaglandin analogs. SAFLUTAN reduces intraocular pressure. It is used when the pressure inside the eye is too high.

What is this medication for?

SAFLUTAN is used to treat a type of glaucoma called open-angle glaucoma, and also a condition known as ocular hypertension in adults. Both conditions are linked to an increase in intraocular pressure and, over time, can affect vision.

Do not use SAFLUTAN

• If you are allergic to tafluprost or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use SAFLUTAN

Note:SAFLUTAN may have the following effects and some of them may be permanent:

• SAFLUTAN may increase the length, thickness, color, and/or amount of eyelashes, and may cause unusual growth of the eyebrows.
• SAFLUTAN may cause darkening of the skin around the eyes. Wipe off any excess solution from the skin. This will reduce the risk of skin darkening.
• SAFLUTAN may change the color of the iris (the colored part of the eye). If SAFLUTAN is used only in one eye, it may become a different color from the untreated eye permanently.
• SAFLUTAN may cause hair growth in areas where the solution comes into contact with the skin surface repeatedly.

Inform your doctor:

• if you have any kidney problems.
• if you have any liver problems.
• if you have asthma.
• if you have other eye diseases.

Children and adolescents

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

Use of SAFLUTAN with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

If you use other eye medicationsin the eye, wait at least 5 minutes after applying SAFLUTAN and before using the other medication.

Pregnancy, breastfeeding, and fertility

If you can become pregnant, you should use an effective contraceptive method during treatment with SAFLUTAN. If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machines

The influence of SAFLUTAN on the ability to drive and operate machines is none. After applying SAFLUTAN, you may notice blurred vision for a time. Do not drive or use any tools or machines until your vision is clear.

SAFLUTAN contains phosphates

This medication contains approximately 0.04mg of phosphates in each drop, equivalent to 1.2mg/ml. If you suffer from severe damage to the cornea (the transparent layer at the front of the eye), treatment with phosphates, in rare cases, may cause blurred vision due to calcium accumulation.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is 1 drop of SAFLUTAN in one eye or both, once a day, at night. Do not instill more drops or use it more frequently than indicated by your doctor.

This may make SAFLUTAN less effective.

Use only SAFLUTAN in both eyes if your doctor instructs you to do so.

For use only as eye drops. Do not ingest.

Usage Instructions:

When starting a new bottle:

Do not use the single-use containers if the bottle is open. Open the bottle along the dotted line. Write the date when you opened the bottle, in the space reserved for the date, on the bottle.

Each time you use SAFLUTAN:

1. Wash your hands.
2. Remove the strip of single-use containers from the bottle.
3. Break off a single-use container from the strip
4. Place the remaining strip back in the bottle and fold the edge to close the bottle.
5. Make sure the solution is at the bottom of the single-use container.

1. To open the container, unscrew the tab.

1. Incline your head back.
2. Place the tip of the container near the eye.

1. Pull the lower eyelid down and look up.

1. Gently press the container and let one drop fall into the space between the lower eyelid and the eye.

1. Close your eye for a moment and press the inner corner of the eye with your finger for about a minute. This helps prevent the drop from draining into the tear duct.
2. Wipe away any excess solution from the skin around the eye.

If a drop does not fall into the eye, try again.

If your doctor has told you to use eye drops in both eyes, repeat steps 7 to 12 in the other eye. The contents of a single-use container are sufficient for both eyes. Dispose of the open container with the remaining contents immediately after use.

If you use other eye medications, wait at least five minutes after applying SAFLUTAN and before using the other medication.

If you use more SAFLUTAN than you should,it is unlikely to cause serious harm. Apply the next dose at the usual time.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20.

If you forget to use SAFLUTAN,apply one drop as soon as you remember, and return to your regular schedule. Do not use a double dose to make up for missed doses.

Do not stop using SAFLUTAN without consulting your doctor. If you interrupt treatment with SAFLUTAN,the pressure inside the eye will increase again. This may cause permanent damage to the eye.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them. Most side effects are not serious.

Frequent side effects

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

Effects on the nervous system:

• headache

Effects on the eyes:

• itching of the eyes
• eye irritation
• eye pain
• eye redness
• changes in the length, thickness, and amount of eyelashes
• dry eyes
• sensation of a foreign body in the eye
• change in color of the eyelashes
• eyelid redness
• small areas of inflammation on the surface of the eye
• light sensitivity
• tearful eyes
• blurred vision
• decreased ability to see details
• change in color of the iris (may be permanent)

Less frequent side effects

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

Effects on the eyes:

• change in color of the skin around the eyes
• swelling of the eyelids
• fatigue of the eyes
• swelling of the surface membranes of the eye
• tearful eyes
• inflammation of the eyelids
• signs of inflammation inside the eye
• eye discomfort
• pigmentation of the surface membranes of the eye
• follicles on the surface membranes of the eye
• allergic inflammation
• abnormal sensation in the eye

Effects on the skin and tissues under the skin:

• unusual hair growth on the eyelids

Unknown frequency: cannot be estimated from available data

Effects on the eyes:

• inflammation of the iris/choroid (central layer of the eye)
• sunken eyes
• macular edema/cystoid macular edema (inflammation of the retina inside the eye leading to worsening of vision)

Effects on the respiratory system:

• worsening of asthma, difficult breathing

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the single-dose container, the bag, and the box after “EXP” or “CAD”. The expiration date is the last day of the month indicated.

Store the aluminum bags unopened in the refrigerator (between 2°C and 8°C). Do not open the bag until you are ready to use the eye drops, as the containers must be discarded 28 days after opening the bag for the first time.

After opening the aluminum bag:

• Keep the single-dose containers in the original aluminum bag.
• Do not store at a temperature above 25°C.
• Discard unused single-dose containers after 28 days from the date of the first opening of the aluminum bag.
• Discard the opened single-dose container with the remaining solution immediately after use.

Medications should not be disposed of through the drains or in the trash. Deposit the containers and medications you do not need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you do not need. In this way, you will help protect the environment.

Composition of SAFLUTAN

• The active ingredient is tafluprost. 1 ml of solution contains 15 micrograms of tafluprost.
• A single-dose vial (0.3 ml) contains 4.5 micrograms of tafluprost. One drop (approximately 30 µl) contains approximately 0.45 micrograms of tafluprost.
• The other components are glycerol, dihydrogen phosphate disodium dihydrate, edetate disodium, polisorbate 80, and water for injection preparations. Hydrochloric acid, sodium hydroxide, or both are added to adjust the pH.

Appearance of the product and contents of the package

SAFLUTAN is a transparent and colorless liquid (solution) that is supplied in single-dose plastic vials containing 0.3 ml of solution. In a bag, 10 single-dose vials are provided. SAFLUTAN is supplied in vials containing 30 or 90 single-dose vials. Only some sizes of vials may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Santen Oy

Niittyhaankatu 20

33720 Tampere

Finland

Responsible manufacturer:

Santen Oy

Kelloportinkatu 1

33100 Tampere

Finland

Further information about this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

Santen Pharmaceutical Spain S.L.

Acanto, 22, 7th floor

28045 Madrid

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

Last review date of this leaflet:September 2021

Detailed and updated information about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/