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TAFLUPROST 15 MICROGRAMS/ML EYE DROPS SINGLE-DOSE CONTAINER

Active substance(s): TAFLUPROST

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Package leaflet: Information for the patient

Saflutan® 15 micrograms/ml eye drops, solution, 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.
 Your medicine is called Saflutan® 15 micrograms/ml eye drops,
solution, single-dose container but will be referred to as Saflutan
throughout the remainder of this 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.

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.

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.
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.

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.

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.
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 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.
 Store in a refrigerator (2oC-8oC).
 After opening the foil pouch:
 Keep the single-dose containers in the original foil pouch
 Do not store above 25oC
 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 your medicine becomes discoloured or shows any sign of
deterioration, return it to your pharmacist.
 Medicines should not be disposed of via waste water 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
- 1 ml of solution contains 15 micrograms of tafluprost. One singledose container (0.3ml) of eye drops, solution, 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 eye drops solution in single dose
containers. Each pouch contains 10 single-dose containers (in 2 strips of
5 ampoules).
Saflutan is supplied in packs containing 30 single-dose containers.
Manufacturer:
Laboratoire Unither, ZI La Guerie, F-50211 Coutances Cedex, France.
Procured from within the EU by the Product Licence holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd
PL: 33532/0479
Saflutan® 15 micrograms/ml eye drops, solution, single-dose
container
Leaflet dated 14th September 2015
Leaflet coded xxxxxx

POM

Saflutan® is a registered trademark of Merck Sharp & Dohme Corp, USA

Package leaflet: Information for the patient

Tafluprost 15 micrograms/ml eye drops, single dose container
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 is called Tafluprost 15 micrograms/ml eye drops, single
dose container but will be referred to as Tafluprost throughout the
remainder of this leaflet.
What is in this leaflet:
1. What Tafluprost is and what it is used for
2. What you need to know before you use Tafluprost
3. How to use Tafluprost
4. Possible side effects
5. How to store Tafluprost
6. Contents of the pack and other information
1. What Tafluprost is and what it is used for
What kind of medicine is it and how does it work?
Tafluprost eye drops contain tafluprost, which belongs to a group of
medicines called prostaglandin analogues. Tafluprost lowers the
pressure in the eye. It is used when the pressure in the eye is too high.
What is your medicine for?
Tafluprost 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
Tafluprost 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
Tafluprost in your eye. Do not drive or use any tools or machines until
your vision is clear.
3. How to use Tafluprost
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 Tafluprost 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 Tafluprost less effective.
Only use Tafluprost 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 Tafluprost:
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 Tafluprost
Do not use Tafluprost:
 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 Tafluprost.
Please note that Tafluprost may have the following effects and that
some of them may be permanent:
 Tafluprost may increase the length, thickness, colour and/or number of
your eyelashes and may cause unusual hair growth on your eyelids.
 Tafluprost 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.
 Tafluprost may change the colour of your iris (the coloured part of your
eye). If Tafluprost 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
Tafluprost is not recommended for children and adolescents below
18 years due to a lack of data on safety and efficacy.
Other medicines and Tafluprost
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 Tafluprost and the other medication.
Pregnancy, breast-feeding and fertility
If you may become pregnant, you must use an effective method of birth
control during Tafluprost therapy. Do not use Tafluprost if you are
pregnant. You should not use Tafluprost if you are breast-feeding.
Ask your doctor for advice.

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.

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 Tafluprost and the other medication.
If you use more Tafluprost 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 Tafluprost, 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 Tafluprost without asking your doctor. If you stop
using Tafluprost, 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 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 Tafluprost
 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 in a refrigerator (2oC-8oC).
 After opening the foil pouch:
 Keep the single-dose containers in the original foil pouch
 Do not store above 25oC
 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 your medicine becomes discoloured or shows any sign of
deterioration, return it to your pharmacist.
 Medicines should not be disposed of via waste water 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 Tafluprost contains
- 1 ml of solution contains 15 micrograms of tafluprost. One singledose container (0.3ml) of eye drops, solution, 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 Tafluprost looks like and contents of the pack
Tafluprost is a clear colourless eye drops solution in single dose
containers. Each pouch contains 10 single-dose containers (in 2 strips of
5 ampoules).
Tafluprost is supplied in packs containing 30 single-dose containers.
Manufacturer:
Laboratoire Unither, ZI La Guerie, F-50211 Coutances Cedex, France.
Procured from within the EU by the Product Licence holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd
PL: 33532/0479
Tafluprost 15 micrograms/ml eye drops, single dose container
Leaflet dated 14th September 2015
Leaflet coded xxxxxx

POM

Expand view ⇕

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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