Package Insert: Information for the Patient

Taflotan 15 micrograms/mL Eye Drops Solution

Tafluprost

Read this entire package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

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

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

What is this medication used for?

Taflotan 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 Taflotan

• 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 Taflotan.

Please note thatTaflotan may have the following effects and some of them may be permanent:

• Taflotan may increase the length, thickness, color, and/or amount of eyelashes, and may cause abnormal hair growth on the eyelids.
• Taflotan 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.
• Taflotan may change the color of the iris (the colored part of the eye). If Taflotan is used only in one eye, it may become a different color from the untreated eye permanently.
• Taflotan 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

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

Other medications and Taflotan

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 Taflotan 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 Taflotan. Do not use Taflotan if you are pregnant. You should not use Taflotan if you are breastfeeding. 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 machinery

Taflotan has little influence on the ability to drive and operate machinery. After applying Taflotan, you may notice blurred vision for a time. Do not drive or use any tools or machinery until your vision is clear.

Taflotan 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 is1 drop of Taflotan in one eye or in both, once a day, at night. Do not instill more drops or use it more frequently than indicated by your doctor.

This may make Taflotan less effective.

Use only Taflotan in both eyes if your doctor instructs you to.

For use only as eye drops. Do not ingest.

Instructions for use:

When using it for the first time, before applying a drop to the eye, you must first practice using the bottle, slowly pressing it to let a drop fall outside the eye.

When you are sure you can apply a single drop each time, choose the most comfortable position for drop instillation (you can sit, lie on your back, or stand in front of a mirror).

When starting a new bottle:

Do not use the bottle or if the plastic ring around the neck of the bottle is not there or is broken. Write the date you opened the bottle in the space reserved for the date, on the outer box.

Each time you use Taflotan:

There will be a residual volume of approximately 1 ml, which should not be administered. Do not attempt to empty the bottle.

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 6 to 9 in the other eye.

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

If you use more Taflotan 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 forgot to use Taflotan,apply a single drop as soon as you remember, and return to your regular schedule. Do not use a double dose to compensate for missed doses.

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

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 eye:

• itching in the eyes
• eye irritation
• eye pain
• eye redness
• changes in the length, thickness, and amount of eyelashes
• dryness in the eye
• sensation of having a foreign body in the eye
• change in the color of the eyelashes
• eyelid redness
• small areas of inflammation on the surface of the eye
• sensitivity to light
• tearful eyes
• blurred vision
• decreased ability to see details
• change in the 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 eye:

• change in the color of the skin around the eyes
• swelling of the eyelids
• tired 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 eye:

• 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 label of the bottle and on the box, after “CAD”. The expiration date is the last day of the month indicated.

Store in the refrigerator (between 2°C and 8°C). Do not freeze.

After opening the bottle, store below 25°C.

Store in the original packaging to protect it from light.

You must discard the bottle 3 months after opening it for the first time, to prevent infections, and use a new bottle.The 3 ml filled bottle is intended for a period of use of 1month, the 5 ml filled bottle for 2months, and the 7ml filled bottle for 3months.

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

Taflotan Composition

• Active Ingredientis tafluprost. 1 ml of solution contains 15 micrograms of tafluprost. 1 drop contains approximately 0.45 micrograms of tafluprost.
• Other Componentsare glycerol, dihydrogen phosphate dihydrate, disodium edetate, polysorbate 80, and water for injection. Hydrochloric acid and/or sodium hydroxide are added to adjust the pH.

Appearance of the Product and Contents of the Package

Taflotan is a transparent and colorless liquid (solution) that is practically free of visible particles. It is presented in a box that contains 1 transparent plastic bottle with 3 ml, 5 ml, or 7 ml, or 3 transparent plastic bottles with 3 ml of solution in each bottle. The plastic bottles are closed with stoppers.

Only some sizes of packaging 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

Or

Tubilux Pharma, S.p.A.

Via Costarica 20/22

00071 Pomezi, Rome

Italy

For more information about this medication, please contact the local representative of the marketing authorization holder:

Santen Pharmaceutical Spain, S.L.

Acanto, 22, 7th floor

28045 Madrid

Phone: 91 414 24 85

This medication 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:June 2023

For detailed information about this medication, please visit the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)