SAFLUTAN 15 Microgram/ML Eye Drops Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TAFLUPROST

Available from:

Primecrown 2010 Ltd

ATC code:

S01EE05

INN (International Name):

TAFLUPROST

Dosage:

15 Microgram/ML

Pharmaceutical form:

Eye Drops Solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Prostaglandin analogues

Authorization status:

Authorised

Authorization date:

2014-11-14

Patient Information leaflet

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. 

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
som

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Saflutan 15 micrograms/ml, eye drops, solution in single-dose container
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of eye drops, solution, contains 15 micrograms of tafluprost.
One single-dose container (0.3 ml) of eye drops, solution, contains 4.5 micrograms of tafluprost.
One drop (about 30 µl) contains about 0.45 micrograms of tafluprost.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution in single-dose container (eye drops).
_Product imported from Italy:_
A clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Reduction of elevated intraocular pressure in open angle glaucoma and ocular hypertension.
As monotherapy in patients:
who would benefit from preservative free eye drops
insufficiently responsive to first line therapy
intolerant or contra-indicated to first line therapy.
As adjunctive therapy to beta-blockers.
Saflutan is indicated in adults
18 years.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is one drop of SAFLUTAN in the conjunctival sac of the affected eye(s) once daily in the
evening.
The dose should not exceed once daily as more frequent administration may lessen the intraocular pressure lowering
effect.
For single use only, one container is sufficient to treat both eyes. Any unused solution should be discarded immediately
after use.
_Use in elderly_
No dosage alteration in elderly patients is necessary.
_Paediatric population_
The safety and efficacy of tafluprost in children below age 18 has not yet been established. No data are available.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 17/11/2014_
_CR