Saflutan

Package leaflet: Information for the patient

SAFLUTAN 15 micrograms/ml

Eye drops, solution
Tafluprost

Read this entire leaflet carefully before 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 give it to others, even if they have the same symptoms as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What SAFLUTAN is and what it is used for
2. What you need to know before using 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 the pressure inside the eye. 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 of these conditions are related to increased pressure inside the eye and can eventually damage 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 using SAFLUTAN.
Please note that SAFLUTAN may cause the following effects, some of which may be permanent:

• SAFLUTAN may increase the length, thickness, pigmentation, and/or number of eyelashes and may cause unusual hair growth on the eyelids.
• SAFLUTAN may cause darkening of the skin around the eyes. Remove any residual solution from the skin. This will reduce the risk of skin darkening.
• SAFLUTAN may change the colour of the iris (the coloured part of the eye). If SAFLUTAN is used in only one eye, the colour of the treated eye may permanently become different from that of the other eye.
• SAFLUTAN may cause hair growth in areas where the solution repeatedly comes into contact with the skin surface.

Tell your doctor

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

Children and adolescents
The use of SAFLUTAN is not recommended in children and adolescents under 18 years of age due to lack of data on safety and efficacy.
Other medicines and SAFLUTAN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are applying other ocular medicines, wait at least 5 minutes between the application of SAFLUTAN and the other medicine.
Pregnancy, breastfeeding and fertility
If you are able to become pregnant, you must use an effective method of contraception during treatment with SAFLUTAN. Do not use SAFLUTAN during pregnancy. You must not use SAFLUTAN while breastfeeding. Consult your doctor.
Driving and using machines
SAFLUTAN does not affect the ability to drive or operate machinery. However, after applying SAFLUTAN, you may experience transient blurred vision. Do not drive or operate tools or machinery until your vision has cleared.
Important information about some SAFLUTAN excipients
SAFLUTAN contains benzalkonium chloride.
Benzalkonium chloride may cause ocular irritation.
Contact lenses
Benzalkonium chloride is known to discolour soft contact lenses.
Therefore, avoid contact with soft contact lenses.
Remove contact lenses before applying SAFLUTAN and wait at least 15 minutes before reinserting them.

3. How to use SAFLUTAN

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 drop of SAFLUTAN in each eye to be treated, once daily, in the evening. Do not use more drops or use the medicine more frequently than prescribed by your doctor. Doing so could make SAFLUTAN less effective.
Use SAFLUTAN in both eyes only if your doctor has specifically instructed you to do so.
For topical ophthalmic use only. Do not swallow.

Instructions for use:
When starting a new bottle:
Do not use the bottle if the plastic seal covering the cap and neck is missing or broken.
Remove the plastic seal. Record the date of opening the bottle in the space provided on the outer carton.

Each time you use SAFLUTAN:

1. Wash your hands.
2. Open the bottle. Be especially careful to avoid touching the dropper tip of the bottle to your eye, the skin around your eye, or your fingers.
3. Tilt your head backward and turn the

bottle upside down above your eye.

4. Pull the lower eyelid downward and

look upward. Gently squeeze the bottle to release one drop of eye drop solution into the space between the lower eyelid and the eye.

5. Close your eye briefly and press with your finger

on the inner corner of the eye for about one minute. This helps prevent the eye drop from draining through the tear duct.

6. Wipe away any excess solution on the skin around the eye.
7. Replace the cap and close the bottle tightly.

If the drop did not enter the eye, repeat the procedure.
If your doctor has prescribed you to apply the eye drops in both eyes, repeat steps 3 to 7 for the other eye.
If you are using other eye medications, wait at least 5 minutes between applying SAFLUTAN and the other medication.

If you use more SAFLUTAN than you should, it is unlikely to cause serious harm. Apply the next dose at your usual time.
If the medicine is accidentally swallowed, seek medical advice from your doctor.

If you forget to use SAFLUTAN, apply one drop as soon as you remember, then return to your regular dosing 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 stop treatment with SAFLUTAN, the pressure inside the eye will rise again. This may cause permanent damage to the eye.

If you have any questions about 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 of the side effects are not serious.

Very common side effects
The following effects may affect more than 1 in 10 people:
Eye effects:

• eye redness

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

• headache

Eye effects:

• eye itching
• eye irritation
• eye pain
• changes in length, thickness, and number of eyelashes
• dry eye
• sensation of a foreign body in the eye
• alteration in eyelash colour
• redness of the eyelids
• small pinpoint areas of inflammation on the eye surface
• light sensitivity
• increased tearing
• blurred vision
• reduced ability of the eye to distinguish details
• change in iris colour (may be permanent)

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

• change in skin colour around the eyes
• swollen eyelids
• tired eyes
• swelling of the eye's superficial membranes
• eye discharge
• inflammation of the eyelids
• signs of inflammation inside the eye
• eye discomfort
• pigmentation of the eye's superficial membranes
• follicles on the eye's superficial membranes
• allergic inflammation
• abnormal sensation in the eye

Skin and subcutaneous tissue effects:

• unusual growth of fine hair on the eyelids

Not known: frequency cannot be estimated from the available data
Eye effects:

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

Respiratory system effects:

• worsening of asthma, shortness of breath

In very rare cases, some patients with severe damage to the clear layer at the front of the eye (cornea) have developed cloudy spots on the cornea due to calcium deposits during treatment.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SAFLUTAN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle label and on the carton after "Exp". The expiry date refers to the last day of the month.
Do not store above 25°C.
Keep in the original packaging.
To prevent infections, discard the bottle 28 days after first opening and use a new one.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What SAFLUTAN contains

• The active substance is tafluprost. 1 ml of solution contains 15 micrograms of tafluprost. A bottle (2.5 ml) of eye drops, solution, contains 37.5 micrograms of tafluprost.
• The other components are benzalkonium chloride (preservative), glycerol, sodium dihydrogen phosphate dihydrate, disodium edetate, polysorbate 80, and water for injections. Hydrochloric acid and/or sodium hydroxide are added to adjust the pH.

Description of the appearance of SAFLUTAN and contents of the pack
SAFLUTAN is a clear, colourless liquid (solution), supplied in packs of 1 or 3 transparent plastic bottles, each containing 2.5 ml of solution. The plastic bottles are closed with a screw cap. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Santen Italy S.r.l.
Via Roberto Lepetit
8/10 - 20124 Milano
Manufacturer
Santen Oy
Niittyhaankatu 20
FI-33720 Tampere
FINLAND

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Germany, Finland	Taflotan
Italy	Saflutan

More detailed information on this medicinal product is available on the website of the Italian Medicines Agency.

Patient information leaflet

SAFLUTAN 15 micrograms/ml

Eye drops, solution in single-dose container
Tafluprost
Please read this leaflet carefully before 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

7. What SAFLUTAN is and what it is used for
8. What you need to know before using SAFLUTAN
9. How to use SAFLUTAN
10. Possible side effects
11. How to store SAFLUTAN
12. Contents of the pack and other information

7. 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 the pressure inside the eye and 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 conditions are related to increased pressure inside the eye and can eventually damage vision.

8. 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 using SAFLUTAN.
Please note that SAFLUTAN may cause the following effects, some of which may be permanent:

• SAFLUTAN may increase the length, thickness, pigmentation, and/or number of eyelashes and may cause unusual growth of eyelid hair.
• SAFLUTAN may cause darkening of the skin around the eyes. Remove any residual solution remaining on the skin. This will reduce the risk of skin darkening.
• SAFLUTAN may change the colour of the iris (the coloured part of the eye). If SAFLUTAN is used in only one eye, the colour of the treated eye may permanently become different from that of the other eye.
• SAFLUTAN may cause increased hair growth in areas where the solution repeatedly comes into contact with the skin surface.

Inform your doctor if:

• you have kidney problems
• you have liver problems
• you suffer from asthma
• you suffer from other eye diseases.

Children and adolescents
The use of SAFLUTAN is not recommended in children and adolescents under 18 years of age due to lack of safety and efficacy data.
Other medicines and SAFLUTAN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are applying other medicines into the eye, wait at least 5 minutes between the application of SAFLUTAN and the application of the other medicine.
Pregnancy, breast-feeding and fertility
If you are able to become pregnant, you must use an effective method of contraception during treatment with SAFLUTAN. Do not use SAFLUTAN during pregnancy. Do not use SAFLUTAN while breast-feeding. Consult your doctor.
Driving and using machines
SAFLUTAN does not affect the ability to drive or use machinery. However, blurred vision may occur transiently after application of SAFLUTAN. Do not drive or operate tools or machinery until your vision has cleared.

9. How to use SAFLUTAN

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
The recommended dose is 1 drop of SAFLUTAN in each eye to be treated, once daily, in the
evening. Do not use more drops or use the medicine more frequently than prescribed by your
doctor. Doing so may make SAFLUTAN less effective.
Use SAFLUTAN in both eyes only if your doctor has specifically instructed you to do so.
For ocular use only. Do not swallow.

Instructions for use:
When opening a new pouch
Do not use the single-dose container if the pouch is damaged. Open the pouch along the dotted line.
Write the date of opening on the space provided on the pouch.
Each time you use SAFLUTAN

1. Wash your hands.
2. Remove the strip of containers from the pouch.
3. Detach one single-dose container from the strip.
4. Return the strip to the pouch and fold the corner of the pouch to close it.

5. Check that the solution is at the bottom of the single-dose container.

6. To open the container, unscrew the tab.

7. Tilt your head backward.
8. Hold the tip of the container close to the eye.

9. Pull the lower eyelid down and look upward.
10. Gently squeeze the container and let one drop fall into the space between the lower eyelid and the eye.
11. Close your eye briefly and press with

your finger on the inner corner of the eye for
about one minute. This helps prevent the eye drops from draining through the tear duct.

12. Wipe away any excess solution on the skin around the eye. If the drop does not enter the eye, repeat the procedure.

If your doctor has prescribed you to apply the eye drops in both eyes, repeat steps 7 to 12 for
the other eye.
One single-dose container contains enough dose for both eyes. After use, immediately discard the opened container, including any remaining solution.
If you are using other eye medications, wait at least 5 minutes between applying SAFLUTAN and the other medication.
If you use more SAFLUTAN than you should, it is unlikely to cause serious harm. Apply the next dose at your usual time.
If the medicine is accidentally swallowed, seek advice from your doctor.
If you forget to use SAFLUTAN, apply one drop as soon as you remember, then return to your regular dosing 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 stop treatment with SAFLUTAN, the pressure inside the eye will rise again. This may cause permanent damage to the eye.
If you have any questions about how to use this medicine, consult your doctor, pharmacist, or nurse.

10. Possible side effects

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

Common side effects
The following effects may occur in up to 1 in 10 people:
Effects on the nervous system:

• headache

Effects on the eye:

• eye itching
• eye irritation
• eye pain
• eye redness
• changes in length, thickness, and number of eyelashes
• dry eye
• sensation of foreign body in the eye
• alteration of eyelash colour
• redness of the eyelids
• small pinpoint inflamed areas on the eye surface
• light sensitivity
• increased tearing
• blurred vision
• reduced ability of the eyes to distinguish details
• change in iris colour (may be permanent)

Uncommon side effects
The following effects may occur in up to 1 in 100 people:
Effects on the eye:

• change in skin colour around the eyes
• swollen eyelids
• tired eyes
• swelling of the eye's superficial membranes
• eye discharge
• inflammation of the eyelids
• signs of inflammation inside the eye
• eye discomfort
• pigmentation of the eye's superficial membranes
• follicles on the eye's superficial membranes
• allergic inflammation
• abnormal eye sensitivity

Effects on the skin and subcutaneous tissue:

• unusual growth of fine hair on the eyelids

Frequency not known: frequency cannot be estimated from the available data
Effects on the eye:

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

Effects on the respiratory system:

• worsening of asthma, shortness of breath

In very rare cases, some patients with severe damage to the clear layer at the front of the eye (cornea) have developed cloudy spots on the cornea due to calcium deposits during treatment.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

11. How to store SAFLUTAN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the single-dose container, on the foil pouch, and on the box after 'Exp.'. The expiry date refers to the last day of the month.
Store the aluminium foil pouches in a refrigerator (2°C – 8°C). Do not open the pouch until ready to use the eye drops, because unused containers contained in an opened pouch must be discarded 28 days after the first opening of the pouch.
After opening the aluminium foil pouch:

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

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What SAFLUTAN contains

• 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 microliters) 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 and/or sodium hydroxide are added to adjust the pH.

Description of the appearance of SAFLUTAN and contents of the pack
SAFLUTAN is a clear, colourless liquid (solution), supplied in single-dose plastic containers, each containing 0.3 ml of solution. Ten single-dose containers are provided in a pouch. SAFLUTAN is available in packs of 30 or 90 single-dose containers. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Santen Italy S.r.l.
Via Roberto Lepetit
8/10 - 20124 Milano
Manufacturer
Laboratoire Unither
ZI La Guérie
50211 Coutances Cedex
FRANCE
This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Bulgaria, Czech Republic, Denmark, Estonia, Finland, Hungary, Iceland, Latvia, Lithuania, Norway, Poland, Slovakia, Sweden	Taflotan
Germany	Taflotan sine
Austria, Belgium, Cyprus, France, Greece, Ireland, Italy, Luxembourg, Malta, Netherlands, Portugal, Romania, Slovenia, Spain, United Kingdom	Saflutan

More detailed information on this medicinal product is available on the website of the Italian Medicines Agency.