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SAFLUTAN 15 MICROGRAMS/ML EYE DROPS SOLUTION IN SINGLE-DOSE CONTAINER

Active substance(s): TAFLUPROST

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65NOT2520/H/270215-3

3931

1SAFL2520GB
Pack

formation for the patient

SAFLUTAN® 15 micrograms/ml
Eye drops, solution in single
dose-container
T

rost

carefully before you start using this medicine
because it contains important information for you.

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 e ects, talk to your doctor, pharmacist or nurse.
This includes any possible side e ects not listed in this l
.
See section 4.
:
Wha
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 e ects
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 con
rost, 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 a ect your eyesight.

Pregnancy, breast-feeding and fertility
If you may become pregnant, you must use an e ective 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
SAFLUT
ce on the ability to drive and use machines.
at your vision is blurred for a time just after you put
You ma
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 e ective.
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.

2. What you need to know before you use SAFLUTAN
Do not use SAFLUTAN:
• if you are allergic t
rost 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 e ects 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
ny excess solution from the skin. This will reduce the
eyes. W
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 di erent 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.
Children and adolescents
SAFLUTAN is not recommended for children and adolescents below
18 years due to a lack of data on safet
cy.
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.

6. To open the container, t
the tab.

7. Tilt your head backwards.
8. 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
y
for about one minute.
This helps to prevent the eye drop
from draining down the tear duct.
12. W
ny excess solution from
the skin around the eye.

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 ar
nt 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 e ects
Like all medicines, this medicine can cause side e ects, although not
everybody gets them. Most side e ects are not serious.
Common side e ects
The following may a ect up to 1 in 10 people:
E ects on the nervous system:
• headache.
E ects 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
ation on the surface of the eye
• small spotlike ar
• 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 e ects
The following may a ect up to 1 in 100 people:
E ects on the eye:
• change of colour of the skin around the eyes

yelids
• tired eyes
• swelling of the eye’s surface membranes
• eye discharge
ation of the eyelids

• sig
ation inside the eye
• discomfort in the eye
• pigmentation of the eye’s surface membranes
• follicles in the surface membranes of the eye
• allerg
ation
• abnormal sensation in the eye.
E ects on the skin and tissue under the skin:
• unusual hair growth on eyelids.
Not known: frequency cannot be estimated from the available data
E ects on the eye:

ation of the iris/uvea (middle layer of the eye)
• eyes appear sunken
• macular oedema/cystoid macular oedema (swelling of the retina
within the eye leading to worsening vision).
E ects on the respiratory system:
• worsening of asthma, shortness of breath

65NOT2520/H/

270215-3

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 e ects
If you get any side e ects, talk to your doctor, pharmacist or nurse. This
includes any possible side e ects not list
You can also report side e ects directly (see details below). By reporting
side e ects you can help provide more information on the safety of this
medicine.
United Kingdom: Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
or search for MHRA Yellow Card in the Google Play or Apple App Store.
Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2,
Tel: +353 1 6764971; Fax: +353 1 6762517, Website: www.hpra.ie;
e-mail: medsafety@hpra.ie
Malta: ADR Reporting, The Medicines Authority, Post-Licensing
Directorate, 203 Level 3, Rue D’Argens, GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt,
e-mail: postlicensing.medicinesauthority@gov.mt
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
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
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 substanc
rost. 1 ml of solution contains
rost. One single-dose container (0.3 ml)
15 microgr
contains 4.5 microgr
rost. One drop (about 30 µl) contains
about 0.45 microgr
rost.
- 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 or 90 single-dose containers. Not all pack sizes may be
marketed.
Marketing Authorisation Holder (UK/Ireland/Malta): Santen Oy,
Niittyhaankatu 20, 33720 Tampere, Finland
Manufacturer: Laboratoire Unither, ZI La Guérie, 50211 Coutances
Cedex, France
This medicinal product is authorised in the Member States of the
EEA under the following names:
Bulgaria, Czech Republic, Denmark, Estonia, Finland,
Hungary, Iceland, Latvia, Lithuania, Norway, Poland,
Slovakia, Sweden
Germany
Austria, Belgium, Cyprus, France, Greece, Ireland,
Italy, Luxembourg, Malta, The Netherlands, Portugal,
Romania, Slovenia, Spain, United Kingdom
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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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