Saflurownd

Package leaflet: Information for the patient

Safluround 15 micrograms/ml

Eye drops, solution
Tafluprost
Please 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 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, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Safluround is and what it is used for

What type of medicine is it and how does it work?
Safluround eye drops contain tafluprost, which belongs to a group of medicines called prostaglandin analogues. Safluround reduces the pressure inside the eye and is used when the pressure within the eye is too high.
What is this medicine used for?
Safluround 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 may eventually impair vision.

2. What you need to know before using Safluround

Do not use Safluround:

• 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 Safluround.
Please note that Safluround may cause the following effects, some of which may be permanent:

• Safluround may increase the length, thickness, pigmentation, and/or number of eyelashes and may cause unusual hair growth on the eyelids.
• Safluround may cause darkening of the skin around the eyes. Remove any residual solution from the skin. This will reduce the risk of skin darkening.
• Safluround may change the colour of the iris (the coloured part of the eye). If Safluround is used in only one eye, the treated eye may permanently become a different colour from the untreated eye.
• Safluround 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 Safluround is not recommended in children and adolescents under 18 years of age due to lack of data on safety and efficacy.
Other medicines and Safluround
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are applying other medicines in the eye, wait at least 5 minutes between the application of Safluround and the application of the other medicine.
Pregnancy, breast-feeding and fertility
If you could become pregnant, you must use an effective method of contraception during treatment with Safluround. Do not use Safluround during pregnancy. Do not use Safluround while breast-feeding. Ask your doctor for advice.
Driving and using machines
Safluround has a minor influence on the ability to drive and use machines. After applying Safluround, you may experience temporary blurred vision. Do not drive or operate tools or machinery until your vision has cleared.

3. How to use Safluround
   Use this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

The recommended dose is 1 drop of Safluround in each affected eye, once daily, in the evening. Do not use more drops or use the medicine more frequently than prescribed by your doctor, as this may reduce the effectiveness of Safluround.
Use Safluround 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 using the bottle for the first time, before instilling a drop into the eye, first practise using the bottle by gently pressing it to release a drop away from the eye.
Once you feel confident in releasing a single drop, choose the position that is most comfortable for you when instilling the eye drops (you may sit, lie on your back, or stand in front of a mirror).
When starting a new bottle:
Do not use the bottle if the pouch is damaged or if the tamper-evident ring around the neck of the bottle is missing or broken.
Open the pouch along the dotted line. Write down the date you opened the bottle in the space provided on the outer carton.
Each time you use Safluround:

1. Wash your hands.
2. When using the bottle for the first time,

remove the tamper-evident ring from the cap by pulling the tab.

3. Open the bottle by removing the cap.
4. When using the bottle for the first time, discard the first drop.
5. Hold the bottle between your thumb and middle

finger.

6. Tilt your head back or lie down. Place your hand on your forehead. Your index finger should be aligned with your eyebrow or resting on the bridge of your nose. Be especially careful not to let the tip of the dropper touch the eye, the skin around the eye, or your fingers, to prevent potential contamination of the solution.
7. Pull the lower eyelid down with your other

hand and look upwards. Gently press the bottle to release one drop into the space between the lower eyelid and the eye. Note that there may be a slight delay between pressing and the drop coming out. Do not press too hard.

8. Close your eye and press the inner corner

of the eye with your finger for about one minute. This helps prevent the eye drop from draining through the tear duct.

9. Remove excess solution from the skin around the eye to reduce the risk of darkening of the eyelid skin.
10. Shake the bottle once downwards to

remove any residual solution from the tip. Do not touch or wipe the tip.

11. Replace the cap and close the bottle securely.

There will be approximately 1 ml of residual volume remaining after using the amount required for 28 days. Do not attempt to empty the bottle.
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 6 to 9 for the other eye.
If you are applying other eye medicines, wait at least 5 minutes between the application of Safluround and the other medicine.
If you use more Safluround than you should, it is unlikely to cause serious problems. Apply the next dose at your usual time.
If the medicine is accidentally swallowed, consult your doctor.
If you forget to use Safluround, apply one single drop as soon as you remember, then return to your regular dosing schedule. Do not use a double dose to make up for a forgotten dose.
Do not stop using Safluround without consulting your doctor. If you stop treatment with Safluround, the pressure inside the eye will rise again, which may cause permanent damage to the eye.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Most 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 a foreign body in the eye
• alteration in eyelash colour
• eyelid redness
• 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.

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 inside 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 http://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 Safluround

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the bottle and on the carton after 'Exp.'. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep in the original packaging to protect the medicine from light.
The bottle must be discarded 28 days after first opening to prevent infections, and a new bottle must be used.
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 Safluround contains

• The active substance is tafluprost. 1 ml of solution contains 15 micrograms of tafluprost. One drop 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 Safluround and contents of the pack
Safluround is a clear, colourless liquid (solution), practically free from visible particles. It is supplied in a pack containing 1 or 3 transparent plastic bottles, each containing 3 ml of solution. The transparent plastic bottles are closed with a cap. Each bottle is packed in a pouch. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Santen Oy
Niittyhaankatu 20
33720 Tampere
Finland

Manufacturer
Santen Oy
Niittyhaankatu 20
33720 Tampere
Finland
Tubilux Pharma SpA
Via Costarica 20/22
00071 Pomezia (Roma)
Italy

This medicinal product is authorised in the European Economic Area countries under the following names:

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