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

Active substance(s): TAFLUPROST

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S1749 LEAFLET Saflutan 20141014

Package leaflet: Information for the patient
®

SAFLUTAN 15 micrograms/ml eye drops,
solution in single-dose container
(tafluprost)
The name of your medicine is SAFLUTAN 15 micrograms/ml eye
drops, solution in single-dose container but will be referred to as
Saflutan throughout the following 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.

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.
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.

2. What you need to know before you use Saflutan

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.

3. How to use Saflutan

For use as eye drops only. Do not swallow.

4. Possible side effects

Instructions for use:

5. How to store Saflutan

When you start a new pouch:

6. Contents of the pack and other information

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.

1. WHAT SAFLUTAN IS AND WHAT IT IS USED FOR

Every time you use Saflutan:

What kind of medicine is it and how does it work?

1. Wash your hands.

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.

2. Take the strip of containers from the pouch.

What is in this leaflet:
1. What Saflutan is and what it is used for

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.

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).

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

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.

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.

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

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.

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

12. Wipe off any excess solution from
the skin around the eye.
If a drop misses your eye, try again.

S1749 LEAFLET Saflutan 20141014

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.

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
Ireland: Pharmacovigilance Section, Irish Medicines Board, Kevin
O’Malley House, Earlsfort Centre, Earlsfort Terrace, IRL - Dublin 2,
Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.imb.ie,
e-mail: imbpharmacovigilance@imb.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

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:


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.



itching of the eye

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.



irritation in the eye

After opening the foil pouch:



eye pain



Keep the single-dose containers in the original foil pouch.



redness of the eye



Do not store above 25°C



changes in the length, thickness and number of eyelashes





dry eye

Discard unused single-dose containers after 28 days from date
of first opening of the foil pouch



foreign body sensation in the eye





discolouration of eyelashes

Discard an opened single-dose container with any remaining
solution immediately after use.



redness of the eyelids



small spotlike areas of inflammation on the surface of the eye



sensitivity to light



watery eyes

6. CONTENTS OF THE PACK AND OTHER INFORMATION



blurred vision

What Saflutan contains



reduction in the eye’s ability to see details

-



change of colour of the iris (may be permanent).

headache.

Effects on the eye:

Uncommon side effects
The following may affect up to 1 in 100 people:
Effects on the eye:

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.

The active substance is tafluprost. 1 ml of solution contains 15
micrograms of tafluprost. One single-dose container (0.3 ml) 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



change of colour of the skin around the eyes



puffy eyelids



tired eyes



swelling of the eye’s surface membranes



eye discharge

Saflutan is a clear, colourless liquid (solution) supplied in singledose 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.



inflammation of the eyelids

Product Licence holder



signs of inflammation inside the eye



discomfort in the eye



pigmentation of the eye’s surface membranes

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer



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

This product is manufactured by
Merck Sharp & Dohme BV, Waarderweg 39, 2031 BN Haarlem,
The Netherlands.
POM

PL No: 19488/1749

Leaflet revision date: 14 October 2014
Saflutan is a registered trademark of the Merck Sharp & Dohme
group of companies.
S1749 LEAFLET Saflutan 20141014

S1749 LEAFLET Tafluprost 20141014

Package leaflet: Information for the patient

TAFLUPROST 15 micrograms/ml eye drops,
solution in single-dose container
The name of your medicine is TAFLUPROST 15 micrograms/ml
eye drops, solution in single-dose container but will be referred to
as Tafluprost throughout the following 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.

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 breastfeeding. Ask your doctor for advice.
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.

2. What you need to know before you use Tafluprost

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.

3. How to use Tafluprost

For use as eye drops only. Do not swallow.

4. Possible side effects

Instructions for use:

5. How to store Tafluprost

When you start a new pouch:

6. Contents of the pack and other information

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.

1. WHAT TAFLUPROST IS AND WHAT IT IS USED FOR

Every time you use Tafluprost:

What kind of medicine is it and how does it work?

1. Wash your hands.

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.

2. Take the strip of containers from the pouch.

What is in this leaflet:
1. What Tafluprost is and what it is used for

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.

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).

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

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.

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.

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

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.

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

12. Wipe off any excess solution from
the skin around the eye.
If a drop misses your eye, try again.

S1749 LEAFLET Tafluprost 20141014

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 inflammatio n 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:

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
Ireland: Pharmacovigilance Section, Irish Medicines Board, Kevin
O’Malley House, Earlsfort Centre, Earlsfort Terrace, IRL - Dublin 2,
Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.imb.ie,
e-mail: imbpharmacovigilance@imb.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 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 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 Tafluprost contains
-

The active substance is tafluprost. 1 ml of solution contains 15
micrograms of tafluprost. One single-dose container (0.3 ml) 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



change of colour of the skin around the eyes



puffy eyelids



tired eyes



swelling of the eye’s surface membranes

Tafluprost is a clear, colourless liquid (solution) supplied in singledose plastic containers, each containing 0.3 ml of solution. Ten
single-dose containers are provided in one pouch. Tafluprost is
supplied in packs containing 30 single-dose containers.



eye discharge

Product Licence holder



inflammation of the eyelids



signs of inflammation inside the eye



discomfort in the eye



pigmentation of the eye’s surface membranes

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer



follicles in the surface membranes of the eye



allergic inflammation



abnormal sensation in the eye.

Effects on the skin and tissue under the skin:


This product is manufactured by
Merck Sharp & Dohme BV, Waarderweg 39, 2031 BN Haarlem,
The Netherlands.
POM

PL No: 19488/1749

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

Leaflet revision date: 14 October 2014

S1749 LEAFLET Tafluprost 20140826

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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