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SAFLUTAN 15 MICROGRAMS/ML EYE DROPS SOLUTION

Active substance(s): TAFLUPROST

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T05772

SAFLUTAN® 15 micrograms/ml eye drops,
solution, in single-dose container
(tafluprost)

Patient Information Leaflet
This medicine is available using the above
name but will be referred to as Saflutan
throughout the Patient Information 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 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.
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

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).
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.
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.

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.

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
container.

6.

To open the container,
twist off the tab.

7.
8.

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

11. Close your eye for a
moment and press the
inner corner of the eye
with your finger for
about one minute. 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.
If a drop misses your eye, try again.

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.

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.

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.

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.

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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.

• 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.

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

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.

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

6. Contents of the pack and other
information

Effects on the nervous system:
• headache.

What Saflutan contains
- 1 ml of solution contains 15 micrograms of
the
active
ingredient
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.

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

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.

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.
Manufacturer and Product Licence Holder
This product is manufactured by Laboratoire
Unither, Zl La Guerie, F-50211 Coutances
Cedex, France. It is procured from within the EU
by the Product Licence Holder: Swinghope
Limited, Brandon House, Marlowe Way,
Croydon CR0 4XS UK. Repackaged by
Interport Limited, Brandon House, Marlowe
Way, Croydon CR0 4XS UK.

POM
PL No: 10380/1592
Leaflet revision date: 20/11/2015
Saflutan® is registered trademark of Merck
Sharp & Dohme Corp., USA.

Effects on the skin and tissue under the skin:
• unusual hair growth on eyelids.
Not known: frequency cannot be estimated
from the available data
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 via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Saflutan
• Keep 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.

T05772

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