Saflutan 15 micrograms/ml eye drops solution in single-dose container

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

SAFLUTAN 15 micrograms/ml

eye drops solution in single-dose container

Tafluprost

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

• Keep this leaflet. 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 pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What SAFLUTAN is and what it is used for

2. What you need to know before you use SAFLUTAN

3. How to use SAFLUTAN

4. Possible side effects

5. How to store SAFLUTAN

6. Contents of the pack and other information

1. What SAFLUTAN is and what it is used for

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

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

What is this medicine used 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 disorders are associated with increased pressure inside the eye and, over time, may affect vision.

2. What you need to know before using SAFLUTAN

Do not use SAFLUTAN

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use SAFLUTAN.

Note: SAFLUTAN may cause the following effects, some of which may be permanent:

• SAFLUTAN may increase the length, thickness, color, and/or number of eyelashes, and may cause unusual growth of eyebrows.
• SAFLUTAN may darken the skin color around the eyes. Dry 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 in only one eye, that eye may permanently become a different color than the untreated eye.
• SAFLUTAN may cause hair growth in areas where the solution repeatedly comes into contact with the skin.

Tell 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 lack of data on safety and efficacy.

Using SAFLUTAN with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

If you use other eye medications, wait at least 5 minutes after applying SAFLUTAN before using the other medicine.

Pregnancy, breastfeeding, and fertility

If you could become pregnant, you must use an effective method of contraception during treatment with SAFLUTAN. If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

SAFLUTAN has no influence on the ability to drive and use machines. However, after applying SAFLUTAN, you may experience blurred vision for a period of time. Do not drive or operate any tools or machinery until your vision is clear.

SAFLUTAN contains phosphates

This medicine contains approximately 0.04 mg of phosphates per drop, equivalent to 1.2 mg/ml. If you have severe corneal damage (the transparent layer at the front of the eye), treatment with phosphates may, in very rare cases, cause blurred vision due to calcium accumulation.

3. How to use SAFLUTAN

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 1 drop of SAFLUTAN in one or both eyes, once daily, in the evening. Do not instill more drops or use it more frequently than indicated by your doctor.

Doing so may make SAFLUTAN less effective.

Use SAFLUTAN in both eyes only if instructed by your doctor.

For ophthalmic use only. Do not ingest.

Instructions for use:

When starting a new pouch:

Do not use the unit-dose containers if the pouch is open. Open the pouch along the dotted line. Write the date you opened the pouch in the space provided for the date on the pouch.

Each time you use SAFLUTAN:

1. Wash your hands.

2. Remove the strip of containers from the pouch.

3. Detach one unit-dose container from the strip.

4. Return the remaining strip to the pouch and fold the edge to close the pouch.

5. Make sure the solution is at the bottom of the unit-dose container.

6. To open the container, unscrew the tab.

7. Tilt your head backward.

8. Place the tip of the container near your eye.

9. Pull down the lower eyelid and look upward.

10. Gently squeeze the container and release one drop into the space between the lower eyelid and the eye.

11. Close your eye for a moment and press with your finger on the inner corner of the eye for about one minute. This helps prevent the drop from draining into the tear duct.

12. Wipe away any excess solution from the skin around the eye.

If a drop does not enter the eye, try again.

If your doctor has instructed you to use the eye drops in both eyes, repeat steps 7 to 12 for the other eye. The contents of one unit-dose container are sufficient for both eyes. Immediately discard the opened container with any remaining solution after use.

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

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20.

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

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

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

4. Possible adverse effects

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

Frequent adverse effects

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

Effects on the nervous system:

• headache

Effects on the eyes:

• itchy eyes
• eye irritation
• eye pain
• redness of the eyes
• changes in the length, thickness, and number of eyelashes
• dry eyes
• sensation of having a foreign body in the eye
• change in eyelash color
• redness of the eyelids
• small inflamed areas at points on the surface of the eye
• light sensitivity
• watery eyes
• blurred vision
• decreased visual acuity (ability to see fine details)
• change in iris color (may be permanent)

Uncommon adverse effects

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

Effects on the eyes:

• change in skin color around the eyes
• eyelid swelling
• tired eyes
• swelling of the superficial membranes of the eye
• watery eyes
• eyelid inflammation
• signs of inflammation inside the eye
• eye discomfort
• pigmentation of the superficial membranes of the eye
• follicles on the superficial membranes of the eye
• allergic inflammation
• abnormal sensation in the eye

Effects on the skin and tissues beneath the skin:

• abnormal growth of eyelid hair

Frequency not known: cannot be estimated from available data

Effects on the eyes:

• inflammation of the iris/uvea (middle layer of the eye)
• sunken eyes
• macular edema/cystoid macular edema (swelling of the retina within the eye leading to worsening vision)

Effects on the respiratory system:

• worsening of asthma, difficulty breathing

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of SAFLUTAN

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the single-dose container, the pouch, and the carton, following “EXP” or “CAD”. The expiry date refers to the last day of the month indicated.

Store unopened aluminium pouches in a refrigerator (between 2°C and 8°C). Do not open the pouch until the time of use, as the containers must be discarded 28 days after the first opening of the aluminium pouch.

After opening the aluminium pouch:

• Keep the single-dose containers in the original aluminium pouch.
• Do not store at temperatures above 25°C.
• Discard unused single-dose containers 28 days after the first opening of the aluminium pouch.
• Immediately discard the opened single-dose container along with any remaining solution after use.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of SAFLUTAN

• The active substance is tafluprost. 1 ml of solution contains 15 micrograms of tafluprost.
• A single-dose container (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, sodium dihydrogen phosphate dihydrate, disodium edetate, polysorbate 80 and water for injections. Hydrochloric acid, sodium hydroxide or both may be added to adjust the pH.

Appearance of the product and contents of the pack

SAFLUTAN is a clear, colourless liquid (solution) supplied in single-dose plastic containers containing 0.3 ml of solution. Each bag contains 10 single-dose containers. SAFLUTAN is available in packs containing 30 or 90 single-dose containers. Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Santen Oy
Niittyhaankatu 20
33720 Tampere
Finland

Manufacturer:

Santen Oy
Kelloportinkatu 1
33100 Tampere
Finland

For further information about this medicinal product, contact the local representative of the Marketing Authorisation Holder:

Santen Pharmaceutical Spain S.L.
Acanto, 22, 7º
28045 Madrid
Spain

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

Date of the most recent review of this leaflet: September 2021

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/