Xalatan 50micrograms/ml Eye Drops Solution

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LATANOPROST

Available from:

Pfizer Hellas S.A.

ATC code:

S01EE01

INN (International Name):

LATANOPROST

Pharmaceutical form:

EYE DROPS, SOLUTION

Composition:

LATANOPROST 50 microgram(s)/millilitre

Prescription type:

POM

Therapeutic area:

OPHTHALMOLOGICALS

Authorization status:

Authorised

Authorization date:

2005-10-31

Patient Information leaflet

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2015-0010445
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. 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 XALATAN:

If you are allergic (hypersensitive) to latanoprost or any of the
other ingredients of

Summary of Product characteristics

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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 with known effect
Benzalkonium chloride 0.2 mg/mL is included as a preservative.
Sodium dihydrogen phosphate monohydrate (E339i) 7.70 mg/mL.
Disodium phosphate anhydrous (E339ii) 1.55 mg/mL.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution.
The solution is a clear, colourless liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Reduction of elevated intraocular pressure (IOP) in patients with open
angle glaucoma and ocular
hypertension in adults (including the elderly).
Reduction of elevated IOP in paediatric patients with elevated IOP and
paediatric glaucoma.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Adults (including the elderly) _
Recommended therapy is one eye drop in the affected eye(s) once daily.
Optimal effect is obtained
if Xalatan is administered in the evening.
The dosage of Xalatan should not exceed once daily since it has been
shown that more frequent
administration decreases the IOP lowering effect.
If one dose is missed, treatment should continue with the next dose as
normal.
_Paediatric population _
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Xalatan Eye drops, solution may be used in paediatric patients at the
same posology as in adults. No
data are available for preterm infants (less than 36 weeks gestational
age). Data in the age group < 1
year (4 patients) are limited (see section 5.1).
Method of administration
As with any eye drops, to reduce possible systemic absorption, it is
recommended that the lachrymal
sac be compressed at the medial canthus (punctal occlusion) for one
minute. This should be performed
immediately following the instillation of each drop.
Contact lenses should be removed before instillation of the eye drops
and