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TAFLOTAN 15 MICROGRAMS/ML EYE DROPS SOLUTION SINGLE-DOSE CONTAINER

Active substance(s): TAFLUPROST

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PATIENT INFORMATION LEAFLET

2563
05.01.15[4]

Saflutan® 15 micrograms/ml eye drops,
solution, single-dose container

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

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

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

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

(tafluprost)
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.
Your medicine will be referred to as Saflutan throughout the following
leaflet.
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.

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.

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.

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.

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.

For use as eye drops only. Do not swallow.
If a drop misses your eye, try again.

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.

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.

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 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 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 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 (see details below). By reporting
side effects you can help provide more information on the safety of this
medicine.
United Kingdom: Yellow Card Scheme Website:
www.mhra.gov.uk/yellowcard
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.
Store the unopened foil pouches in a refrigerator (2°C – 8°C). Store in the
original package. 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.
If the solution becomes discoloured or shows any other signs of
deterioration, consult your pharmacist who will tell you what to do.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to 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.
− 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 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
Manufactured by Santen Oy, Niittyhaankatu 20, FI-33720 Tampere,
Finland.
Procured from within the EU by Product Licence holder:
Star Pharmaceuticals Ltd. 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL 20636/2563

Leaflet revision and issue date (Ref) 05.01.15[4]
Saflutan is a trademark of Merck Sharp & Dohme Corp.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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