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

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tafluprost

Available from:

PCO Manufacturing Ltd.

ATC code:

S01EE; S01EE05

INN (International Name):

Tafluprost

Dosage:

15 microgram(s)/millilitre

Pharmaceutical form:

Eye drops, solution in single-dose container

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Prostaglandin analogues1); tafluprost

Authorization status:

Authorised

Authorization date:

2013-11-25

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
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 ma

Summary of Product characteristics

Health Products Regulatory Authority
08 August 2023
CRN00DLP6
Page 1 of 2
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 microl) contains about 0.45 micrograms of
tafluprost.
Excipient with known effect: contains phosphates
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, Poland, Greece and Romania:_
A clear, colourless solution.
4 CLINICAL PARTICULARS
As per PA0879/006/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0879/006/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Glycerol
Sodium dihydrogen phosphate dihydrate
Disodium edetate
Polysorbate 80
Hydrochloric acid and/or sodium hydroxide for pH adjustment
Water for injections
6.2 INCOMPATIBILITIES
Not applicable
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
After first opening a foil pouch: 28 days.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store in a refrigerator (2°C - 8°C).
Health Products Regulatory Authority
08 August 2023
CRN00DLP6
Page 2 of 2
After opening the foil pouch:
Keep the single-dose containers in the original foil pouch
Do not store above 25°C
Discard an opened single-dose container with any remaining solution
immediately after use.
6.5 NATURE AND CONTENTS OF CONTAINER
Single-dose containers packed in foil pouch. Each single-dose
container has a fill volume of 0.3 ml and there are 10 containers
in each foil pouch, i.e. 30 x 0.3 ml single-dose containers in each
carton.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
Any unused medicinal product or waste material should be disposed of
in accordance with loca