Saflutan 15 micrograms/ml eye drops, solution

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

Saflutan eye drops contain tafluprost, which belongs to a group of medicines called prostaglandin analogues. Saflutan lowers the pressure in the eye. It is used when the pressure in the eye is too high.

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 linked with an increase in the pressure within your eye and eventually they may affect your eyesight.

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

Talk to your doctor, pharmacist or nurse before using Saflutan.

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

• Saflutan may increase the length, thickness, colour and/or number of your eyelashes and may cause unusual hair growth on your eyelids.
• Saflutan may cause darkening of the colour 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 colour of your iris (the coloured part of your eye). If Saflutan is used in one eye only, the colour of the treated eye may permanently become different from the colour of the other eye.
• Saflutan may cause hair growth in areas where the solution comes repeatedly in contact with the skin surface.

Tell your doctor

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

Saflutan is not recommended for children and adolescents below 18 years due to a lack of data on safety and efficacy.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

If you use other medicines in the eye, leave at least 5 minutes between putting in Saflutan and the other medication.

If you may become pregnant, you must use an effective method of birth control during Saflutan therapy. Do not use Saflutan if you are pregnant. You should not use Saflutan if you are breast-feeding. Ask your doctor for advice.

Saflutan has minor influence on the ability to drive and use machines. You may find that your vision is blurred for a time just after you put Saflutan in your eye. Do not drive or use any tools or machines until your vision is clear.

This medicine contains approximately 0.04 mg phosphates in each drop which is equivalent to 1.2 mg/ml. If you suffer from severe damage to the clear layer at the front of the eye (the cornea), phosphates may cause in very rare cases cloudy patches on the cornea due to calcium build-up during treatment.

When using for the first time, before delivering a drop to the eye, you should first of all practise using the bottle by squeezing it slowly to deliver one drop away from the eye.

When you are confident that you can deliver one drop at a time, choose the position that you find most comfortable for the instillation of the drops (you can sit down, lie on your back, or stand in front of a mirror).

When you start a new bottle:

Do not use the bottle if the plastic ring around the bottle neck is missing or broken. Write down the date you opened the bottle in the space reserved for the date on the outer carton.

Every time you use Saflutan:

1. Wash your hands.
2. When you are using the bottle for the first time, remove the tamper-evident ring of the cap by pulling the tab
3. Open the bottle by pulling the cap.
4. When using the bottle the first time, drop one drop to waste.
5. Hold the bottle between your thumb and middle finger.
6. Tilt your head backwards or lie down. Place your hand on your forehead. Your index finger should be aligned with your eyebrow or resting on the bridge of the nose.
Take special care that the tip of the dropper bottle does not touch your eye, the skin around your eye or your fingers to prevent potential contamination of the solution.
7. Pull the lower eyelid downwards with the other hand and look up. Gently squeeze the bottle and let one drop fall into the space between the lower eyelid and the eye. Please note that there might be a slight delay between squeezing and the drop coming out. Do not squeeze too hard.
8. Close the eye and press the inner corner of the eye with your finger for about one minute. Thus you can prevent the eye drop from draining down the tear duct.
9. Wipe off any 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 get rid of any remaining solution from the top. Do not touch or wipe the top.
11. Put the cap back on and close the bottle tightly.

There will be a residual volume of approximately 1 ml, which cannot be dosed. Do not try to empty the bottle.

If a drop misses your eye, try again.

If your doctor has told you to use drops in both eyes, repeat steps 6 to 9 for your other eye.

If you use other medicines in the eye, leave at least 5 minutes between putting in Saflutan and the other medication.

If you use more Saflutan than you should, it is unlikely to cause you any serious harm. Put in your next dose at the usual time.

If the medicine is accidentally swallowed, please contact a doctor for advice.

If you forget to use Saflutan, use a single drop as soon as you remember, and then go back to your regular routine. Do not use a double dose to make up for a forgotten dose.

Do not stop using Saflutan without asking your doctor. If you stop using Saflutan, the pressure in the eye will increase again. This may cause a permanent injury to your eye.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom:

or search for MHRA Yellow Card in the Google Play or Apple App Store.

Ireland:

• The active substance is tafluprost. 1 ml of solution contains 15 micrograms of tafluprost. One drop contains about 0.45 micrograms of tafluprost.
• The other ingredients 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.

Saflutan is a clear, colourless liquid (solution), practically free from visible particles. It is supplied in a pack containing either 1 transparent plastic bottle with 3 ml, 5 ml or 7 ml, or 3 transparent plastic bottles with 3 ml solution each. The plastic bottles are closed with caps. Not all pack sizes may be marketed.

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