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

Active substance: TAFLUPROST

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Package leaflet: Information for the patient

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

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.

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).

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.
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.
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.

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.
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.

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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.
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:

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
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 or 90 single-dose containers. Not all pack sizes may be
marketed.

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.

Marketing Authorisation Holder (UK/Malta): Merck Sharp & Dohme
Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK.
Marketing Authorisation Holder (Ireland): Merck Sharp & Dohme
Ireland (Human Health) Limited, Red Oak North, South County Business
Park, Leopardstown, Dublin 18, Ireland.
Manufacturer: Merck Sharp & Dohme BV, Waarderweg 39, 2031 BN
Haarlem, The Netherlands.
This medicinal product is authorised in the Member States of the
EEA under the following names:

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 at : www.mhra.gov.uk/yellowcard
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.

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
This leaflet was last revised July 2014

PIL.SAF.14.UK.4038.II-023

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Taflotan
Taflotan sine
Saflutan

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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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