Saflutan 15 micrograms/ml eye drops, solution, single-dose container

Kraj: Malta

Język: angielski

Źródło: Malta Medicines Authority

Składnik aktywny:

TAFLUPROST

Dostępny od:

Santen Oy Niittyhaankatu 20, 33720 Tampere, Finland

Kod ATC:

S01EE05

INN (International Nazwa):

TAFLUPROST 15 µg/ml

Forma farmaceutyczna:

EYE DROPS, SOLUTION

Skład:

TAFLUPROST 15 µg/ml

Typ recepty:

POM

Dziedzina terapeutyczna:

OPHTHALMOLOGICALS

Status autoryzacji:

Authorised

Data autoryzacji:

2011-03-28

Ulotka dla pacjenta

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 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

Charakterystyka produktu

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.
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 in single-dose container (eye drops).
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:
o
who would benefit from preservative free eye drops
o
insufficiently responsive to first line therapy
o
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.
_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
To reduce the risk of darkening of the eyelid skin the patients should
wipe off any excess solution
from the ski