Monopost Unidose 50 micrograms/ml eye drops, solution in single-dose container

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Latanoprost

Verfügbar ab:

PCO Manufacturing Ltd.

ATC-Code:

S01EE; S01EE01

INN (Internationale Bezeichnung):

Latanoprost

Dosierung:

50 microgram(s)/millilitre

Darreichungsform:

Eye drops, solution in single-dose container

Therapiebereich:

Prostaglandin analogues1); latanoprost

Berechtigungsdatum:

2019-05-29

Gebrauchsinformation

_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
MONOPOST
®
UNIDOSE
50 MICROGRAMS/ML
eye drops, solution in single-dose container
latanoprost
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 MONOPOST UNIDOSE is and what it is used for
2.
What you need to know before you use MONOPOST UNIDOSE
3.
How to use MONOPOST UNIDOSE
4.
Possible side effects
5.
How to store MONOPOST UNIDOSE
6.
Contents of the pack and other information
1.
WHAT MONOPOST UNIDOSE IS AND WHAT IT IS USED FOR
MONOPOST UNIDOSE belongs to a group of medicines known as
prostaglandins. It lowers the pressure within your eye by increasing
the
natural outflow of fluid from inside the eye into the bloodstream.
MONOPOST UNIDOSE is used to treat conditions known as open angle
glaucoma and ocular hypertension. Both of these conditions are linked
with an increase in the pressure within your eye, eventually affecting
your eye sight.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE MONOPOST UNIDOSE
DO NOT USE MONOPOST UNIDOSE
•
If you are allergic (hypersensitive) to latanoprost or any of the
other
ingredients of this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, or pharmacist or nurse before using MONOPOST
UNIDOSE if you think any of the following apply to you:
•
If you are about to have or have had eye surgery (including cataract
surgery).
•
If you suffer from eye problems (such as eye pain, irritation or
inflammation, blurred vision).
•
If you know that you suffer from dry eyes.
•
If yo

Fachinformation

Health Products Regulatory Authority
06 October 2020
CRN009Y3D
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Monopost Unidose 50 micrograms/ml eye drops, solution in single-dose
container
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml eye drops solution contains 50 micrograms of latanoprost.
One drop contains approximately 1.5 micrograms of latanoprost.
Excipient with known effect: contains polyethylene glycol glycerol
hydroxystearate 40
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution in single-dose container.
Product imported from Greece;
The solution is a slightly yellow and opalescent solution.
4 CLINICAL PARTICULARS
As per PA1107/007/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1107/007/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Polyethylene glycol glycerol hydroxystearate 40
Sorbitol
Carbomer 974P
Polyethylene glycol 4000
Ethylenediaminetetraacetate disodium salt
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 is the date shown on the
container and outer package of the product on the market in
the country of origin.
After first opening of the sachet:
For sachet of 5 single-dose containers: use the single-dose containers
within 7 days
For sachet of 10 single-dose containers: use the single-dose
containers within 10 days
After first opening of the single-dose container: use immediately and
discard the single-dose container after use.
Health Products Regulatory Authority
06 October 2020
CRN009Y3D
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store below 25 °C.
For storage after first opening of the medicinal product, see section
6.3.
6.5 NATURE AND CONTENTS OF CONTAINER
5 or 10 single-dose containers containing 0.2 ml of eye drops solution
are packed in sachet. Pack size: 30 single-dose
containers.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing L