Xalatan 50 micrograms/mL Eye drops, solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Latanoprost

Available from:

Pfizer Healthcare Ireland

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:

Marketed

Authorization date:

1997-07-25

Patient Information leaflet

PAA103204
335959
Puurs
N/A
9 pt
Ireland
05
Leaflet
2981
I028/F
298
105 x 520 mm
I-XALATAN PB
IE
PAR-2018-0002054
PROFILE
BLACK
13:48
BARCODE Nº
ITF 2 OF 5
SUPPLIER Nº
DATE:
04 SEP 2018
TIME:
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SMALLEST
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MARKET
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Package Leaflet: Information for the User
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
g

Summary of Product characteristics

Health Products Regulatory Authority
24 November 2019
CRN008L99
Page 1 of 9
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_
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.
Health Products Regulatory Authority
24 November 2019
CRN008