Xalatan 50 micrograms/ml eye drops, solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Latanoprost

Available from:

LTT Pharma Limited

ATC code:

S01EE; S01EE01

INN (International Name):

Latanoprost

Dosage:

50 microgram(s)/millilitre

Pharmaceutical form:

Eye drops, solution

Administration route:

Eye instillation

Units in package:

Pack size : 1 x 2.5 ml

Prescription type:

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

Manufactured by:

Pfizer Manufacturing Belgium NV

Therapeutic area:

Prostaglandin analogues1); latanoprost

Therapeutic indications:

Reduction of elevated intraocular pressure in patients with open angle glaucoma and ocular hypertension. Reduction of elevated intraocular pressure in paediatric patients with elevated intraocular pressure and paediatric glaucoma

Authorization status:

Authorised

Authorization date:

2015-07-24

Patient Information 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
What Xalatan is and what it is used for
What you need to know before you use
Xalatan
How to use Xalatan
Possible side effects
How to store Xalatan
Contents of the pack and other
information
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.
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)
•
If you are pregnant or trying to become pregnant
•
If you are breast-feeding
WARNINGS AND PRECAUTIONS
Talk t

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Xalatan 50 micrograms/ml eye drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 ml eye drops solution contains 5 mg latanoprost.
One drop contains approximately 1.5 micrograms latanoprost.
Excipient(s) with known effect
Benzalkonium chloride is included as a preservative.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution.
_Product imported from 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
Benzalkonium chloride
Sodium 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
Before first opening: The shelf life expiry date for this product
shall be the date shown on the bottle and outer package
of the product on the market in the country of origin.
After first opening of container: 4 weeks
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6.4 SPE