Xalatan 50 micrograms/mL eye drops, solution

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Latanoprost

Saatavilla:

PCO Manufacturing Ltd.

ATC-koodi:

S01EE; S01EE01

INN (Kansainvälinen yleisnimi):

Latanoprost

Annos:

50 microgram(s)/millilitre

Lääkemuoto:

Eye drops, solution

Prescription tyyppi:

Product subject to prescription which may not be renewed (A)

Terapeuttinen alue:

Prostaglandin analogues1); latanoprost

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2011-04-08

Pakkausseloste

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PACKAGE LEAFLET: INFORMATION FOR THE USER
XALATAN
®
50 MICROGRAMS/ML EYE
DROPS, SOLUTION
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 or the
doctor treating your child or pharmacist.
–
This medicine has been prescribed for you or for your child
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 or the doctor
treating your child or pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Xalatan is and what it is used for
2.
What you need to know before you use Xalatan
3.
How to use Xalatan
4.
Possible side effects
5.
How to store Xalatan
6.
Contents of the pack and other information
1.
WHAT XALATAN IS AND WHAT IT IS USED FOR
Xalatan belongs to a group of medicines known as
prostaglandin analogues. It works by increasing the natural
outflow of fluid from inside the eye into the bloodstream.
Xalatan is used to treat conditions known as OPEN ANGLE
GLAUCOMA and OCULAR HYPERTENSION
in adults. Both of these
conditions are linked with an increase in the pressure within your
eye, eventually affecting your eye sight.
Xalatan
is
also
used
to
treat
increased
eye
pressure
and
glaucoma in all ages of children and babies.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE XALATAN
Xalatan can be used in adult men and women (including the
elderly) and in children from birth to 18 years of age. Xalatan
has not been investigated in prematurely born infants (less than
36 weeks gestation).
DO NOT USE XALATAN:

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 the doctor treating your child or
pharmacist before using Xalatan or before you g

Valmisteyhteenveto

Health Products Regulatory Authority
22 December 2020
CRN00C07S
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Xalatan 50 micrograms/mL eye drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL eye drops solution contains 50 micrograms of latanoprost.
One drop contains approximately 1.5 micrograms latanoprost.
Excipient(s) with known effect:
Benzalkonium chloride
Sodium dihydrogen phosphate monohydrate
Anhydrous Disodium phosphate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution.
_Product sourced from Italy, France, The Netherlands, Norway and the
United Kingdom._
The solution is a clear colourless liquid.
4 CLINICAL PARTICULARS
As per PA0822/140/001.
5 PHARMACOLOGICAL PROPERTIES
As per PA0822/140/001.
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Sodium chloride
Benzalkonium chloride
Sodium dihydrogen phosphate monohydrate (E339a)
Anhydrous disodium phosphate (E339b)
Water for injections
6.2 INCOMPATIBILITIES
_In vitro_ studies have shown that precipitation occurs when eye drops
containing thiomersal are mixed with Xalatan. If such
medicinal products are used, the eye drops should be administered with
an interval of at least five minutes.
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 of container: 4 weeks
Health Products Regulatory Authority
22 December 2020
CRN00C07S
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Keep the bottle in the outer carton in order to protect from light.
Do not store above 25°C.
6.5 NATURE AND CONTENTS OF CONTAINER
Dropper container (5ml) with either a screw cap and tamper evident
overcap or with a screw cap and tamper-evident ring.
Each dropper container contains 2.5 mL eye drops solution
corresponding to approximately 80 drops of solution.
Pack sizes: 1 x 2.5 mL.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
Any unused medicinal product or