Saflutan 15 micrograms/ml eye drops, solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tafluprost

Available from:

Santen OY

ATC code:

S01EE05

INN (International Name):

Tafluprost

Dosage:

15 microgram(s)/millilitre

Pharmaceutical form:

Eye drops, solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

tafluprost

Authorization status:

Marketed

Authorization date:

2019-02-15

Patient Information leaflet

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Package leaflet: Information for the patient
SAFLUTAN 15 MICROGRAMS/ML
EYE DROPS, SOLUTION
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 symptoms 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 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 colo

Summary of Product characteristics

Health Products Regulatory Authority
30 June 2023
CRN00DP7Z
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Saflutan 15 micrograms/ml eye drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of solution contains 15 micrograms of tafluprost
One drop contains about 0.45 micrograms of tafluprost.
Excipient with known effect: One ml of eye drops solution contains 1.2
mg phosphates and one drop contains approximately
0.04 mg phosphates.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution (eye drops).
A clear, colourless solution, practically free from visible particles
with a pH between 5.5 and 6.7, and an osmolality of 260 - 310
mOsmol/kg.
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.
_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.
_Use in renal/hepatic impairment_
Tafluprost has not been studied in patients with renal/hepatic
impairment and should therefore be used with caution in such
patients.
Method of administration
Health Products Regulatory Authority
30 June 2023
CRN00DP7Z
Page 2 of 7
Patients should be informed of the correct handling of the bottle.
When using for the first time, before delivering a drop to the
eye,