Xalatan 50 micrograms/ml eye drops, solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Latanoprost

Available from:

Imbat Limited

ATC code:

S01EE; S01EE01

INN (International Name):

Latanoprost

Dosage:

50 microgram(s)/millilitre

Pharmaceutical form:

Eye drops, solution

Prescription type:

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

Therapeutic area:

Prostaglandin analogues1); latanoprost

Authorization status:

Authorised

Authorization date:

2008-10-24

Patient Information leaflet

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
XALATAN
® 50 MICROGRAMS/ML EYE DROPS, SOLUTION
latanoprost
Your medicine is available using the above name but will be referred
to as Xalatan throughout
this leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT
INFORMATION FOR YOU. EVEN IF YOU HAVE ALREADY USED XALATAN OR A
SIMILAR
MEDICINE BEFORE, WE ADVISE
YOU TO READ THIS TEXT CAREFULLY. THE INFORMATION MAY HAVE
BEEN CHANGED.

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 XAL

Summary of Product characteristics

Health Products Regulatory Authority
25 January 2019
CRN008QF7
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Xalatan 50 micrograms/ml eye drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
100ml eye drops solution contains 5mg latanoprost
One drop contains approximately 1.5 micrograms latanoprost.
Excipient with known effect: Benzalkonium chloride 0.02% w/v is
included as a
preservative.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution
_Product imported from: Italy & UK (as Latanoprost and as Xalatan)_
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.
Health Products Regulatory Authority
25 January 2019
CRN008QF7
Page 2 of 3
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.
Shelf life after opening of container: 4 weeks.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Product imported from Italy (as Xalatan) and UK (as Latanoprost)
Store in a refrigerator (2°C - 8°C)
Keep the bottle in the outer carton in order to protect from light.
After first opening the bottle: do not store above 25°C and use
within four weeks.
Product imported from UK (as Xalatan)
Store at room temperature (below 25°C)
Keep the bottle in the outer carton in order to protect from light.
Use within four weeks of opening.
6.5 NATURE AND CONTENTS OF CONTAINER
Dropper container with either a screw cap and tamper evident ove