Xalatan 50 micrograms/mL Eye drops, solution

Land: Malta

Språk: engelsk

Kilde: Medicines Authority

Aktiv ingrediens:

LATANOPROST

Tilgjengelig fra:

Viatris Hellas Ltd 253-255, Mesogion Avenue, 154 51 Neo Psychiko, Athens,, Greece

ATC-kode:

S01EE01

INN (International Name):

LATANOPROST 50 µg/ml

Legemiddelform:

EYE DROPS, SOLUTION

Sammensetning:

LATANOPROST 50 µg/ml

Resept typen:

POM

Terapeutisk område:

OPHTHALMOLOGICALS

Autorisasjon status:

Authorised

Autorisasjon dato:

2005-10-31

Informasjon til brukeren

Page 1 of 7
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).
Page 2 of 7
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

Preparatomtale

Page 1 of 11
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).
Page 2 of 11
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 may be reinserted after
15