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SAFLUTAN® 15 micrograms/ml, eye drops, solution,
in single-dose container
Your medicine is known by the above name but will be referred to as
SAFLUTAN throughout this leaflet.
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 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 signs of illness are the same as
• 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.
What is in this 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

3. How to use SAFLUTAN
Always use this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is 1 drop of SAFLUTAN in the eye or eyes, once
daily in the evening. Do not instil more drops or use more often than as
instructed by your doctor. This may make SAFLUTAN less effective.
Only use SAFLUTAN in both eyes if your doctor told you to.
For use as eye drops only. Do not swallow.

Instructions for use:
When you start a new pouch:
Do not use the single-dose containers if the pouch is broken. Open the
pouch along the dashed line. Write down the date you opened the pouch
in the space reserved for the date on the pouch.
Every time you use SAFLUTAN:
1. Wash your hands.
2. Take the strip of containers from the pouch.
3. Detach one single-dose container from the strip.
4. Put the remaining strip back in the pouch and fold the edge to close
the pouch.
5. Make sure that the solution is in
the bottom part of the single-dose

1. What SAFLUTAN is and what it is used for
What kind 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 lowers the
pressure in the eye. It is used when the pressure in the eye is too high.
What is your medicine 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 linked with an increase in the pressure within
your eye and eventually they may affect your eyesight.

2. What you need to know before you use SAFLUTAN
Do not use SAFLUTAN:
• if you are allergic to tafluprost or any of the other ingredients of this
medicine (listed in section 6).

6. To open the container, twist off
the tab.

7. Tilt your head backwards.
8. Place the tip of the container
close to your eye.

Warnings and precautions
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.

9. Pull the lower eyelid downwards
and look up.
10. Gently squeeze the container
and let one drop fall into the space
between the lower eyelid and the

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

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

11. Close your eye for a moment
and press the inner corner of the
eye with your finger for about one
This helps to prevent the eye drop
from draining down the tear duct.
12. Wipe off any excess solution
from the skin around the eye.

Other medicines and SAFLUTAN
Tell your doctor or pharmacist if you are taking, have recently taken or
might take other medicines.
If you use other medicines in the eye, leave at least 5 minutes between
putting in SAFLUTAN and the other medication.

Pregnancy, breast-feeding and fertility
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.

Driving and using machines
SAFLUTAN has no 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.

If a drop misses your eye, try again.
If your doctor has told you to use drops in both eyes, repeat steps
7 to 12 for your other eye.
The contents of one single-dose container are sufficient for both eyes.
Discard the opened container with any remaining contents immediately
after use.
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

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 have any further questions on 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 side effects are not serious.

Common side effects
The following may affect up to 1 in 10 people:
Effects on the nervous system:
• headache.
Effects on the eye:
• itching of the eye
• irritation in the eye
• eye pain
• redness of the eye
• changes in the length, thickness and number of eyelashes
• dry eye
• foreign body sensation in the eye
• discolouration of eyelashes
• redness of the eyelids
• small spotlike areas of inflammation on the surface of the eye
• sensitivity to light
• watery eyes
• blurred vision
• reduction in the eye’s ability to see details
• change of colour of the iris (may be permanent).

Uncommon side effects
The following may affect up to 1 in 100 people:
Effects on the eye:
• change of colour of the skin around the eyes
• puffy eyelids
• tired eyes
• swelling of the eye’s surface membranes
• eye discharge
• inflammation of the eyelids
• signs of inflammation inside the eye
• discomfort in the eye
• pigmentation of the eye’s surface membranes
• follicles in the surface membranes of the eye
• allergic inflammation
• abnormal sensation in the eye.
Effects on the skin and tissue under the skin:
• unusual hair growth on eyelids.

Not known: frequency cannot be estimated from the available
Effects on the eye:
• inflammation of the iris/uvea (middle layer of the eye)
• eyes appear sunken
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 (the cornea) have developed cloudy patches on the
cornea due to calcium build-up during treatment.

Reporting of side effects
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
United Kingdom: Yellow Card Scheme Website:

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 which is stated on the
single-dose container, pouch and the carton after ‘Exp’. The expiry date
refers to the last day of that month.
Store the unopened foil pouches in a refrigerator (2°C – 8°C). Do not
open the pouch until you are about to start using the eye drops as
unused containers in an open pouch must be discarded 28 days after
first opening the pouch.
After opening the foil pouch:
• Keep the single-dose containers in the original foil pouch.
• Do not store above 25°C
• Discard unused single-dose containers after 28 days from date of first
opening of the foil pouch
• Discard an opened single-dose container with any remaining solution
immediately after use.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.

6. Contents of the pack and other information
What SAFLUTAN contains
• The active substance is tafluprost. 1 ml of solution contains
15 micrograms of tafluprost. One single-dose container (0.3 ml)
contains 4.5 micrograms of tafluprost. One drop (about 30 μl)
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.

What SAFLUTAN looks like 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 one pouch. SAFLUTAN is supplied in packs
containing 30 single-dose containers.
Merck Sharp & Dohme BV, Waarderweg 39, 2031 BN Haarlem,
The Netherlands.
Procured from within the EU and repackaged by: Amimed Direct Ltd,
Hendon, London, NW9 6AQ.
Product Licence holder: Sam Pharma Ltd, Unit 20 Garrick Industrial
Estate, Irving Way, Hendon, London, NW9 6AQ.

PL No: 33902/0502

This leaflet was last approved: 03/10/2014
SAFLUTAN® is a registered trademark of Merck Sharp & Dohme Corp.

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Further information

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